May 25, 2007
Vitamin D, calcium reduce fracture risk, study says
Vitamin D supplements alone are not enough to lower the risk of hip fractures for the frail elderly and those with osteoporosis, new research indicates.
The risk of hip fractures decreases only if they take oral vitamin D supplements along with additional calcium, according to a report in The Journal of Clinical Endocrinology & Metabolism.
The risk of hip fracture was cut by 18% in study participants receiving vitamin D plus calcium, the report indicates. Vitamin D and calcium work together to restore calcium balance and reduce fracture risk restore bone health, researchers concluded. ------------------------------------------------------------------
May 23, 2007
Popular diabetes drug could be dangerous, study finds
A widely prescribed drug to treat type 2 diabetes increases users' risk for heart attack, according to study findings released this week.
The U.S. Food and Drug Administration reacted to the report with a safety alert for the drug Avandia. It said, however, that more analysis was needed before it would make a decision about the drug from a regulatory standpoint. The generic name for the drug is rosiglitazone.
Researchers found those taking the drug increased their risk of heart attack by 43%. Also, there was a 64% increased risk of dying from cardiovascular causes, compared with patients not taking the drug. Findings will appear in the June 14 issue of the New England Journal of Medicine. More than two million people worldwide take Avandia for type 2 diabetes. Remember that loss of blood sugar control is more risky than the risk of this drug. Consult with your physician or consultant pharmacist as to your alternatives. ----------------------------------------------------------------------
May 3, 2007
Once-a-Year Treatment for Bone Loss, Promising
A simple annual infusion of a new drug is just as effective at reducing bone fractures as weekly or monthly bone loss drugs currently on the market, according to a study by researchers at the University of California San Francisco published today.
The findings on the drug -- called zoledronic acid and marketed as Reclast by Novartis Pharmaceuticals -- could offer millions of older women a more convenient alternative to preventing bone loss. Reclast has not yet been approved by the Food and Drug Administration.
Older women who took Reclast experienced a 70 percent reduction in the risk of spinal fractures and a 41 percent reduction in the risk of hip fractures. Risk of other types of fractures were also reduced, by about 25 percent.
Bone mineral density increased in the spine by 6.7 percent and in the hip by 6 percent among the women on Reclast, according to the study, published in the New England Journal of Medicine.
The three-year study involved 7,700 postmenopausal women with osteoporosis in 27 countries. About half of the women were given Reclast once a year for three years and the other half got a placebo.
The women had a mean age of 73 years and the study included women up to age 89.
"This drug could be quite effective, especially for people who don't tolerate other osteoporosis drugs well," said Dennis Black, professor of epidemiology and biostatistics at the UCSF School of Medicine and lead author of the study.
Common osteoporosis drugs -- such as Fosamax, Actonel and Boniva - - are typically administered in a weekly or monthly pill or liquid form. The medication must be taken on an empty stomach with a full glass of water and the person must sit upright for at least 30 minutes afterwards. A common side effect is an upset stomach.
About half of patients prescribed these oral treatments stop taking them after one year, previous studies have found.
"People just don't continue to take the oral medications," Black said. "Partially it's because it's a general problem of any preventative medicine that doesn't make you feel better when you take it."
Reclast is in this same class of drugs as Fosamax, called biophosphonates. It is given once a year in a 15-minute 5 milligram infusion that can be administered in a doctor's office or hospital.
It has been approved in Mexico and several other countries and is still in the FDA approval process.
Reclast leaves the bloodstream within 24 hours but the drug "has a high affinity to adhere to the bone and stays there," making the effect of the infusion long-lasting, Black said.
The drug remained effective for a year or more, according to the study.
About a quarter of the women in the study experienced mild side effects after their first Reclast infusion, including chills, nausea, bone pain and back pain. Those symptoms typically subsided within three days. On subsequent yearly infusions, side effects were far less common, Black said.
More worrisome, a small number of patients developed atrial fibrillation, a condition of abnormal heart rhythms that can lead to stroke. The risk of developing this heart problem was about 2.5 times higher in patients given Reclast than those in the control group.
Though rare -- one event in 150 women over the three years -- this result surprised researchers because previous studies where cancer patients were given higher doses of Reclast did not indicate atrial fibrillation as a side effect, Black said. More studies on this are forthcoming.
"To some extent, the jury is still out on whether it is a real finding." he said.
Fosamax has also been linked to a slight increase in incidence of atrial fibrillation.
Safety concerns that Reclast could cause kidney damage, osteonecrosis of the jaw, a rare jaw bone condition, or cause the bone to lose its ability to repair itself were not borne out by this study, which was funded by Novartis.
More than 50 million women in the United States, Europe and Japan have osteoporosis. Half of those women over age 50 will have a resulting hip fracture in their lifetime. One in five women over 65 who fracture a hip die within one year. Men also get osteoporosis but at much lower rates; there are 2 million men with the disease in the United States.
Reclast could be a good option for the growing number of very elderly women with osteoporosis, Dr. Juliet Compston, professor of bone medicine at the University of Cambridge School of Clinical Medicine in England, wrote in an editorial published with the study.
"The practicality and acceptability of annual intravenous therapy in large numbers of women remains to be tested," Compston wrote.
"Nevertheless, increased treatment choices for patients are to welcomed." ----------------------------------------------------------------------
May 3, 2007
Genetic flaws may point way on diabetes
Scientists find new risk factors for the disease
Decades after scientists first realized that the risk of getting diabetes was partially inherited, discoveries of real genetic defects are suddenly coming rapid-fire.
Yesterday, four separate scientific teams, including one led by Harvard researchers, reported three new genetic risk factors and confirmed five others identified over the last few years. An additional risk factor identified by one group has not yet been confirmed by others.
The discoveries open up new avenues to explain what breaks down in the body to cause type 2 diabetes. More than 20 million Americans suffer from diabetes and another 54 million are at risk. In the future, scientists said, the genetic findings may also help predict who will get the illness and lead to treatments tailored to each individual's genetic makeup.
"This is a milestone," said Dr. Larry C. Deeb, president for medicine and science of the American Diabetes Association, who was not involved in the research. "We're moving out of the darkness into understanding a lot more about diabetes."
The researchers identified some genetic areas that are not connected to any known mechanism behind diabetes, which harms the body's ability to control blood sugar and can lead to heart disease, blindness, and early death.
"No one had the first clue that these genetic changes were involved in the disease," said David Altshuler, associate professor of genetics and medicine at Harvard Medical School and a leader of one of the three collaborating teams.
Some of the genetic changes are in what scientists previously called "junk DNA," he said, areas of the genetic code that they previously thought were meaningless. "Our whole view of which parts of the human genome contribute to disease is being augmented."
Genetics accounts for about half the risk of getting type 2 diabetes, according to Altshuler. Environment and such behaviors as obesity and lack of exercise account for the remaining risk.
The eight confirmed genetic defects together account for about 5 percent of the risk of getting the illness, he said. "The picture that is emerging is of multiple genes, each with a modest effect" on diabetes, he added.
However, scientists from the National Institutes of Health found that in one group of subjects, people with the most defects had a four times higher risk of having diabetes than people with the fewest defects.
Scientists said much work remains before genetic testing for diabetes becomes useful for patients. Researchers also expect it may be up to a decade before new treatments result from the work.
"The pharmaceutical industry is absolutely salivating at all of these studies" because they suggest targets for new drugs, said Dr. Francis Collins, director of the National Human Genome Research Institute and a leader of another of the teams. "But there is a long lead time."
The results were published yesterday in the on line editions of the journals Science and Nature Genetics. They are based on a new research technique called genome wide association studies, in which scientists compare genetic samples from thousands of individuals who have a specific illness with those who don't.
The work is also unusual because three of the four scientific groups collaborated to confirm their results, drawing on the largest database of DNA ever used to study diabetes and making the findings extremely solid.
"Only five years ago this work would have been unthinkable," said Collins.
Each of the four groups used genetic material from a different population, totaling tens of thousands of subjects.
The three groups that coordinated to confirm each other's results were led by scientists from Britain; the National Institutes of Health and Finland; and the Broad Institute at Harvard and MIT, Sweden, and the pharmaceutical company Novartis.
The three variations they found are near genes that appear to be related to regulation of insulin, which controls blood sugar, and to growth of the cells in the pancreas that produce insulin. In diabetes, the body becomes resistant to insulin or fails to make enough insulin, causing a problematic build-up of sugar in the blood stream. The actual effect of the genetic defects has yet to be determined.
Separately, deCODE Genetics , a company in Iceland, reported finding one of the same genes in an Icelandic population and confirming it in samples of people from other nations. The Harvard research also identified a genetic defect linked to high trigyclerides in the blood, a risk factor for heart disease. The NIH team identified an additional genetic link to diabetes that was not confirmed by the other groups. And the British and NIH groups confirmed a genetic change tied to obesity.
Using the same technique, a French consortium reported finding two diabetes-related genes in February, and deCODE reported finding the genetic variation most strongly linked to the disease in January 2006. Two other genes were identified in 2000. --------------------------------------------------------------------------
May 2, 2007
Study offers hope for memory restoration in Alzheimer's patients
The use of certain cancer drugs or a stimulating environment appear to restore the memories of laboratory mice that have symptoms mimicking Alzheimer's disease, researchers say.
The results offer hope for people with dementia, according to researchers at the Massachusetts Institute of Technology's Picower Institute of Learning and Memory.
For the study, bioengineered mice got their memories back after either being placed in stimulating environments or given a drug most commonly used to fight cancer. An "enriched" environment had shelves, perches, nesting material and tunnels. The study results were published online in the Journal Nature. -------------------------------------------------------------------
April 27, 2007
Many Stop Drug After Adverse Reaction
Ninety-four percent of U.S. adults who have had an adverse reaction to a prescription drug say they stopped taking a medication, a survey found.
Forty-six percent of U.S. adults currently taking prescription medications report they are only fairly confident, somewhat confident, or not at all confident that their prescribed medications are safe, according to a poll of 1,726 adults interviewed online by Harris Interactive for the Pharmaceutical Safety Institute.
Almost one-half of patients polled report they are concerned about adverse reactions, and more than one-third report having had an adverse reaction to a prescription medication.
More than one-third of all adults who have ever taken a prescription medication report having had an adverse reaction, according to the survey.
These concerns and experiences lead to prescription-drug non-adherence. Thirty-five percent of people who have ever taken a prescription medication reported they had decided not to take a prescription drug because they had a concern about a potential adverse reaction. -----------------------------------------------------------
April 24, 2007
No Generic Substitution of AEDs Without Physician and Patient Consent, Says AAN
Generic substitution of antiepilepsy drugs (AEDs) should not occur without the full knowledge and consent of both the treating physician and the patient, according to a position statement released by the American Academy of Neurology (AAN).
Published in the April 17 issue of Neurology, the paper addresses the long- standing issue of whether generic substitution of AEDs places patients with epilepsy at undue risk for breakthrough seizures in the name of reducing health costs.
According to the AAN position statement, the US Food and Drug Administration (FDA) allows for significant differences between name-brand and generic drugs. However, for some patients with epilepsy, even minor differences in the composition of anticonvulsant drugs can make a big difference.
All-or-Nothing Phenomenon
"Epilepsy is unlike other disorders. The marker for success is whether or not you're having seizures and whether or not you're having side effects. So unlike a condition such as hypertension, where, if you make a change in dose you can monitor blood pressure to determine whether it's working or not, with epilepsy you have an all-or-nothing phenomenon — you're either seizure free or you're not," Gregory Barkley, MD, from Wayne State University in Detroit, Michigan, one of the AAN position statement authors, told Medscape.
"As an organization whose goal is to improve the lives of people with neurologic problems in general, and the lives of people with epilepsy in particular, the AAN feels it is important we speak out on behalf of patients who we know have had problems because they have been switched [to generic AEDs], frequently without their knowledge," he added.
Dr. Barkley also pointed out the consequences of switching to a generic anticonvulsant that results in subsequent breakthrough seizures or adverse events can be devastating.
"Having a breakthrough seizure could mean a person could lose their driver's license or their job or injure themselves or someone else. This has to be weighed against the potential cost savings of switching to a generic anticonvulsant," he said.
Adverse Events Underreported?
In an accompanying editorial, Michel Berg, MD, from the University of Rochester School of Medicine and Dentistry, in New York, suggests one of the reasons the FDA remains unconvinced there is an equivalency issue between generic and brand-name AEDs is because physicians are not reporting such events through MedWatch, the FDA's voluntary drug-reporting system.
According to Dr. Berg, several surveys have shown that the majority of physicians and patients perceive that generic AEDs are not always equivalent to the brand-name drug. But this is not reflected in case reports to MedWatch. He suggests this may, in part, be due to a lack of physician awareness of the MedWatch system.
Dr. Barkley added that underreporting of such events might also be due to the fact that in many cases, physicians are simply not aware that their patients have been switched to a generic agent.
"Unless a patient specifically says to a doctor that their pills look different or they know for a fact that they've been switched [to a generic drug], physicians may attribute a breakthrough seizure or increased side effects to the brand-name drug," he said.
In addition to opposing generic substitution without physician and patient consent, the AAN statement also supports the use of newer-generation anticonvulsant drugs, which generally have a much more favorable adverse-event profile but tend to be more expensive.
"The AAN believes that physicians should make every effort to identify when patients may be effectively treated with less expensive alternatives. However, the discretion for this decision should remain with the prescribing physician and should not be determined by coverage limitations," the authors write.
According to Dr. Barkley, because of the higher cost of these agents, some insurers are putting up "roadblocks" to prevent physicians from prescribing them by imposing a painstaking and protracted approval process.
As a result, he said, the AAN's position statement also opposes prior authorization requirements by public and private formularies. --------------------------------------------------------------------
April 23, 2007
Studies examine link between HRT and cancer risks
An analysis published in the NEJM suggests that the decline in the use of hormone replacement therapy in 2002 is the most likely explanation for the "sharp" decline in the rate of breast cancer cases in the US in 2003. Use of HRT began to decline in the US after concerns over the drugs' safety emerged from the Women Health Initiative study.
In the initial analysis of data from the National Cancer Institute's registries, the findings showed that the breast cancer rate in the US decreased by 6.7 percent between 2002 and 2003, and that the rate for 2004 remained almost unchanged. Between 2001 and 2004, the breast cancer rate fell 8.6 percent, with the decrease evident in women 50 years and older, and "more evident in cancers that were oestrogen-receptor positive." The analysis also showed that prescriptions for Wyeth's HRT drugs Prempro and Premarin decreased to 27 million prescriptions in 2003, compared to 61 million in 2001.
"The missing cancers, the ones that don't seem to have occurred, are the kinds that are responsive to hormone therapy,'' remarked lead author, Peter Ravdin. "The decline was not a one-year wonder, a short-lived anomaly.'' The researchers added that "the contributions of other causes to the change in incidence seem less likely to have played a major role but have not been excluded."
Wyeth's senior vice president of global medical affairs, Joseph Camardo, stated that the company disagrees "with the conclusion that links the decrease in breast cancer rates with the decline in hormone therapy usage. It might be prudent to look for a broader explanation for the trend in 2003 and 2004." Hugh Taylor, of Yale University, added that "even if there was a cause-and-effect, you wouldn't expect it to show up for five or 10 years. It just doesn't fit with what we know about the basic biology of breast cancer."
Separately, in a study published in The Lancet, researchers examined data from about 950 000 postmenopausal women in the UK who had not previously had cancer. The results demonstrated that for every 1000 women taking HRT, 2.6 developed ovarian tumours over five years, compared with 2.2 cases in every 1000 women who did not use HRT. The death rates from ovarian cancer over five years were 1.6 cases per 1000 and 1.3 cases per 1000 for those taking HRT and those not taking HRT, respectively.
"The effect of HRT on ovarian cancer should not be viewed in isolation especially since the use of HRT also affects the risk of breast and endometrial cancer," the researchers noted. "The total incidence of these three cancers in the study population is 63 percent higher in current users of HRT than never users. ---------------------------------------------------------------------
April 22, 2007
Baby boomers less healthy than parents, study finds
For the first time in history, the next generation reaching retirement - the baby boomers - may actually be less healthy than their parents were at the same age, according to new study results.
While baby boomers tend not to smoke as much and describe themselves as healthy and vibrant, researchers at the University of Texas at Austin found that they are more likely to report difficulty climbing stairs, getting up from a chair and doing other routine activities. In addition, the study, which was reported in the Washington Post, shows that more boomers have chronic problems that include diabetes, high cholesterol and high blood pressure.
Baby boomers tend to be less physically active than their parents and grandparents. Increasingly sedentary lifestyles and work routines are largely to blame, according to the report. -------------------------------------------------------------------
April 17, 2007
Drug monograph update on Zanaflex®
AcordaTherapeutics the makers of Zanaflex® announced changes along with the FDA to the“ Contraindications and Warnings” statements in the Zanaflex monograph on April 11, 2007.
Recent postmarketing studies have shown that when co-administered with CYP 1A2 inhibitors the serum concentrations of tizanidine(Zanaflex®) are significantly increased. This serum level increase raises the potential for adverse effects of sedation and hypotension. Use with the following agents should be avoided especially in the geriatric population. Explanation: CYP 1A2 are the isozymes (chemicals in the liver) that breaks down and metabolizes the drug (Zanaflex). There are multitudes of the different chemicals with different names that breakdown many different drugs. Subjecting more than one drug to that named isozyme chemical causes stress and unpredictable outcomes when co-administered together. Therefore any of the drugs listed below act on the same chemical and may cause very unpredictable outcomes and side effects.
CYP 1A2 inhibitors:
antiarrythmics
amiodarone
atazanavir
cimetidine
ciprofloxacin
citalopram
clarithromycin
diltiazem
echinacea
enoxacin
erythromycin
ethinyl estradiol
famotidine
fluvoxamine
fluroquinolones isoniazid
ketoconazole
methoxsalen
mexiletine
nalidixic acid
norethindrone
omeprazole
oral contraceptives
paroxetine
tacrine
ticlopidine
tipranavir
troleandomycin
zileuton -----------------------------------------------------------
April 13, 2007
FDA: Bladder Drug Needs Stronger Warning
Johnson & Johnson's Ditropan, used to calm an overactive bladder, should have stronger warnings that the drug may cause hallucinations and agitation in children, U.S. regulators said.
The frequency of these side effects is "disproportionately higher" among children taking Ditropan than adults, said a review posted Monday on the Food and Drug Administration's Web site. The medicine's labeling already lists general precautions about central- nervous system side effects.
The agency staff said it will suggest the new age-specific warnings at an advisory panel meeting scheduled Wednesday to discuss the drug, which is approved for use by children over age 5. Since 2002, about 1.3 million Americans under age 17 have filled prescriptions for oxybutynin, the active ingredient in Ditropan, according to data compiled by Verispan LLC.
Regulators reviewed 1,667 reports of side effects in Ditropan users, including 116 reports from children, at the request of the FDA's Pediatric Advisory Committee. At least 31 percent of reports from children involved hallucination, agitation or another problem with the central nervous system, while only 11 percent of adult cases included these events. ---------------------------------------------------------------------
April 3, 2007
Oral Alzheimer's vaccine shows promise
Humans will test a new oral vaccine for Alzheimer's as early as next year, according to the director of a Japanese research institute that is testing the vaccine.
The vaccine has proven effective and safe in mice, said Takeshi Tabira, director of the National Institute for Longevity Sciences in Aichi, central Japan. It reduced the amount of amyloid plaques - which characterize Alzheimer's disease - in the brain and improved mental function. The treatment did not cause inflammation or bleeding in the brains of the mice, Tabira noted.
Research on this project is expected to be published by the Federation of American Societies for Experimental Biology in July. Another Alzheimer's vaccine ACC-001, by U.S. drugmaker Wyeth and its Irish partner Elan Corp, is in early stage human trials -------------------------------------------------------------------
March 30, 2007
Pergolide Withdrawn From US Market
March 29, 2007 — The manufacturers of pergolide in its brand-name (Permax; Valeant Pharmaceuticals) and generic forms have agreed to take it off the market after a pair of studies implicated the dopamine agonist in causing serious heart valve damage, the US Food and Drug Administration (FDA) has announced [1].
Two case control studies published in the January 4, 2007 issue of the New England Journal of Medicine (NEJM) found significantly increased rates of valvular dysfunction in patients with Parkinson's disease taking pergolide and another dopamine agonist, cabergoline [2,3]. As reported at the time by heartwire, the findings were consistent with abundant clinical and mechanistic evidence that activators of the serotonin receptor 5-hydroxytryptamine 2B (5-HT2B), such as pergolide and cabergoline, cause a histologically distinct form of fibrotic valvulopathy. Cabergoline is approved in the US for the treatment of hyperprolactinemic disorders at doses much lower and safer than those used in Parkinson's disease, according to the FDA statement, which was published online today.
Those NEJM studies, along with the availability of other dopamine agonists for Parkinson's disease, have led pergolide manufacturers to withdraw the drug voluntarily, which will have a delayed effect on pharmacy inventories, according to the FDA: "This delay will allow time for healthcare professionals and patients to discuss appropriate treatment options and to change treatments." Manufacturers of the generic products, the agency notes, include Par Pharmaceutical Companies and Teva Pharmaceutical Industries.
The FDA recommends that patients currently taking pergolide contact their healthcare providers to discuss alternative treatments but not go off the drug on their own. Clinicians are urged to assess alternatives and, if necessary, substitute another dopamine agonist; others remaining on the market have not been linked to valve disease. Current pergolide therapy should not be stopped abruptly but should be gradually tapered, the agency cautions.
- http://www.fda.gov/cder/drug/advisory/pergolide.htm
- Schade R, Andersohn F, Suissa S, et al. Dopamine agonists and the risk of cardiac-valve regurgitation. N Engl J Med 2007; 356:29-38.
Zanettini R, Antonini A, Gatto G, et al. Valvular heart disease and the use of dopamine agonists for Parkinson's disease. N Engl J Med 2007; 356:39-46. --------------------------------------------------------------
March 30, 2007
Novartis suspends US sales of Zelnorm over safety concerns
In a public health advisory, the FDA stated that Novartis agreed to stop selling irritable bowel syndrome drug, Zelnorm (tegaserod), after a new safety analysis revealed an increased risk of heart attack, stroke and worsening chest pain in patients receiving the drug. Novartis indicated that it is complying with the agency's request. The company's shares fell as much as 4 percent on the news.
The FDA asked the drugmaker to halt marketing and sales of the compound after a retrospective analysis of data from 29 clinical trials of Zelnorm showed a statistically significant imbalance in the incidence of cardiovascular ischemic events such as heart attack, stroke and unstable angina in patients who received the drug, compared to patients who took placebo. Cardiovascular ischemic events occurred in 13 of 11 614 patients treated with Zelnorm, compared to one case in 7031 patients administered placebo.
James Shannon, global head of development at Novartis Pharma, stated that "although we have complied with the FDA's request and are collaborating with the agency, we continue to believe that Zelnorm provides important benefits for appropriate patients." In its advisory, the FDA specified that it is willing to consider a limited re-introduction of Zelnorm sometime in the future if a patient population for whom the benefits of the drug outweigh the risks can be identified. -------------------------------------------------------------------------
March 29, 2007
Angioplasty No Better Than Drugs, Study Says
A large and long-awaited study finds that angioplasty works no better than medication at preventing heart attacks or death, a finding that could slow the growth of one of medicine's most common cardiac interventions.
The research comes on the heels of a growing debate over whether some patients are getting unnecessary angioplasty, a procedure that involves using a tiny balloon and metal scaffolds called stents to prop open clogged arteries.
Angioplasty is recommended for those with fully blocked arteries or who have had a heart attack. But the new study, presented at the American College of Cardiology's annual meeting in New Orleans yesterday, should give doctors and their patients with partially obstructed arteries the confidence to put off angioplasty or to skip surgery altogether, according to the researchers.
"The results are very striking," said Dr. Steven Nissen , president of the American College of Cardiology, who was not involved in the study. "This is important for patients because it does now mean patients have choices. If your symptoms aren't so severe and aren't interfering with your lifestyle, you can afford to wait."
Half of the 2,300 patients studied underwent angioplasty and took heart drugs, and were told to make lifestyle changes, such as exercising, losing weight, and giving up smoking. The other half received only lifestyle counseling and medication, including drugs to lower cholesterol, relax blood vessels, slow heart rate, and prevent blood clots. Both groups fared equally well after an average of 4 1/2 years, according to the study, also published online yesterday in The New England Journal of Medicine.
Stent manufacturer Boston Scientific Corp. of Natick criticized the study yesterday as not breaking any new ground, and said stents improve quality of life for patients with clogged arteries. The authors said their research suggested that improvements in quality of life were not statistically significant over the course of the study.
The use of angioplasty to open clogged arteries has taken off since the mid-1990s, increasing from about 430,000 procedures in 1995 to nearly 1.3 million in 2004, with many of the more recent surgeries being done proactively, rather than after a life-threatening event.
The popularity of angioplasty has spurred debate among cardiologists, some of whom think the procedure is overused.
Dr. William Boden of Buffalo General Hospital said he designed the new study to determine how much added benefit angioplasty provided for people with few symptoms -- and was surprised to discover that, statistically, there was none.
The good news for patients, he said in a news conference: "You are no more or less at risk of developing a heart attack or dying if you defer angioplasty until some time down the road."
Angioplasty did provide a better quality of life than drugs alone for patients experiencing angina, the discomfort or chest pain that occurs when the heart muscle is deprived of oxygen.
Nissen said that angioplasty remains the treatment of choice for patients with a fully blocked artery, and that campaigns are underway to make sure patients having heart attacks are taken to hospitals that can swiftly perform an angioplasty.
Nissen and others said they think the procedure is probably done more often than needed, though the study's authors said they did not want to speculate about the amount of overuse.
Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center, said the bottom line is that patients and doctors need to make sure they're using angioplasty for the right reasons.
"To place a stent to reduce the chances of a heart attack or to prevent someone from dying, those are not reasons to put in a stent," said Maisel, chairman of a federal panel that examined stent safety.
Boston doctors tend toward the conservative, so they probably use the procedure less often than doctors elsewhere, according to Dr. Frederic S. Resnic, director of the cardiac catheterization laboratory at Brigham and Women's Hospital. Roughly 30 percent of the Brigham patients who get angioplasty have heart disease but are not in immediate danger of having a heart attack, he said.
"We have always been very careful to have detailed discussions with our patients with stable coronary artery disease, to make sure that they are comfortable and understand that we are considering the procedure to relieve the symptoms of angina, and reduce the number and amount of medications needed," he said.
The team of researchers, which included several from Hartford Hospital and the VA Connecticut Healthcare System, said their study may offer fresh evidence that heart disease is more of a systemwide than a localized problem in the body.
Using a stent addresses just one problem spot, but fails to correct other potentially more dangerous fat deposits in the diseased arteries.
The study, known as COURAGE, was paid for by the US Department of Veterans Affairs and the Canadian Institutes of Health Research, as well as 11 pharmaceutical companies, including Pfizer Inc., the maker of the world's top-selling drug, the cholesterol-lowering pill Lipitor.
The researchers acknowledge that one significant limitation of their study was that 85 percent of the patients were men and only 14 percent were non white.
Boston Scientific, which makes drug-coated stents, was sharply critical of the study.
"The results of the COURAGE trial don't really tell us much we didn't already know about the relative benefits of stents over drug therapy in the treatment of cardiovascular disease," the company said in a statement. "Stents have improved the lives of millions of patients, as amply demonstrated by a broad range of clinical trials and real-world experiences, but their benefits are found in safe, durable, and minimally-invasive relief of angina, rather than in further improving the already good survival of stable angina patients on medical therapy."
The company also criticized the study for failing to include drug-coated stents, which were not on the market when the study began.
Boden said that because drug-coated stents have not been shown to improve lifespan, using them instead of bare-metal stents would not have changed the study's results. -------------------------------------------------------------------- March 27, 2007
Antidepressants might improve brain function in stroke victims
The use of antidepressants appears to boost brain function affecting overall reasoning and functioning in stroke victims, whether or not they had symptoms of depression, according to new research.
Researchers randomly assigned 47 stroke patients admitted to a rehabilitation center to one of two antidepressants, nortriptyline and Prozac, or an inactive placebo. While researchers observed no differences among the treatment groups at 12 weeks, 21 months later they found that those given an antidepressant experienced noticeable improvement in executive function. The condition of the majority of patients given the placebo had deteriorated significantly, researchers at the University of Iowa Carver College of Medicine found.
The study was published in the March issue of the British Journal of Psychiatry. ------------------------------------------------------------------------ March 18, 2007
Heart disease, diabetes, depression could be deadly combo
Heart disease, diabetes, depression. It's the recipe for a lethal cocktail, according to new research findings.
The presence of all three diseases can boost a patient's death by 20% to 30%, says researcher Anastasia Georgiades, of Duke University in Durham, N.C. The Duke team followed 933 heart patients for more than four years. During that time, there were 135 deaths among patients with type 2 diabetes and/or depression, the researchers found. There was a higher risk of dying among patients with moderate-to-severe symptoms of depression who were also diabetics, compared with patients with either depression alone or diabetes alone.
The reason for the increased risk is unclear, "but it could either be that depression influences crucial aspects of self-care behaviors needed to manage diabetes or that a more severe disease process is reflected in more depressive symptoms," Georgiades said. -------------------------------------------------------------------- March 16, 2007
FDA Says Pills Can Cause 'Sleep-Driving'
WASHINGTON - All prescription sleeping pills may sometimes cause sleep-driving, federal health officials warned Wednesday, almost a year after the bizarre side effect first made headlines when Rep. Patrick Kennedy crashed his car after taking Ambien.
It's a more complicated version of sleepwalking, but behind the wheel: getting up in the middle of the night and going for a drive - with no memory of doing so.
The Food and Drug Administration wouldn't say exactly how many cases of sleep-driving it had linked to insomnia drugs, but neurology chief Dr. Russell Katz said the agency uncovered more than a dozen reports - and is worried that more are going uncounted.
Given the millions of prescriptions for insomnia drugs, Katz called the problem rare, and said he was unaware of any deaths. But because sleep-driving is so dangerous - and there are precautions that patients can take - the FDA ordered a series of strict new steps Wednesday.
First, the makers of 13 sleep drugs must put warnings on their labels about two rare but serious side effects:
-sleep-driving, along with other less dangerous "complex sleep-related behaviors" - like making phone calls, fixing and eating food, and having sex while still asleep.
-and life-threatening allergic reactions, as well as severe facial swelling, both of which can occur either the first time the pills are taken or anytime thereafter.
Next, doctors this week will begin getting letters notifying them of the new warnings.
Later this year, all prescription sleeping pills will begin coming with special brochures called "Medication Guides" that spell out the risks for patients in easy-to-understand language.
Sleep-driving made headlines last May when Kennedy, D-R.I., crashed his car into a security barrier outside the U.S. Capitol after taking Ambien and a second drug, Phenergan, an anti-nausea pill that also acts as a sedative. Kennedy has said he had no memory of the event. He pleaded guilty to driving under the influence of prescription drugs, and was sentenced to court-ordered drug treatment and a year's probation.
Ambien isn't the only insomnia drug that can cause sleep-driving - any of the class known as "sedative-hypnotics" can, FDA's Katz stressed Wednesday.
To lower the risk of a sleep-driving episode, he advised patients to never take any prescription insomnia drug along with alcohol or any other sedating drug. Also, don't take higher-than-recommended doses of the pills.
"We really want people to know these things can occur, and these sleep behaviors can be perhaps to a large extent mitigated by behaviors the patients can control," he said.
Some of the insomnia drugs may be riskier than others, so FDA also recommended that manufacturers conduct clinical trials to figure that out.
The drugs are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; Sonata.
Fewer than one in 1,000 patients in studies of Ambien reported somnambulism - a scientific term that includes the sleep behaviors flagged by the FDA - said Lisa Kennedy, a spokeswoman for manufacturer Sanofi-Aventis SA, who is not related to the congressman. The side effect has remained similarly rare since widespread sales began, she said. ---------------------------------------------------------------------
March 5, 2007
FDA Warns Migraine Medicine Makers
WASHINGTON - The government said Thursday it had warned the world's largest maker of generic drugs and 19 other companies that they are illegally selling migraine medicines without federal approval.
The Food and Drug Administration said the 20 warning letters were part of an effort to halt the marketing of unapproved and potentially dangerous drugs. The goal is to get the unapproved drugs off the market, agency officials said. The manufacturers could seek agency approval for the products.
The prescription migraine treatments contain a drug called ergotamine tartrate. Ergotamine is derived from a rye fungus called ergot, from which a separate drug, the illegal hallucinogen LSD, also can be synthesized. Ergotamine is a vasoconstricting drug, meaning it narrows the blood vessels when taken.
The letters - dated Monday but not publicly disclosed until Thursday - went to companies that include a U.S. subsidiary of Israel's Teva Pharmaceutical Industries Ltd., the world's largest generics manufacturer. Other recipients included Iceland's Actavis and Sandoz Inc., a pioneer in the marketing of ergotamine tartrate that is now part of Switzerland's Novartis AG.
Messages left with all three companies were not immediately returned Thursday.
The FDA said the companies have 60 days to stop making the drugs and 180 days to stop distributing them. Otherwise, the companies are subject to seizure or injunction, the FDA said.
"Because these drugs don't have approval, we don't know how they were formulated or manufactured. We don't know if they are safe or effective," Deborah Autor, director of the office of compliance within the FDA's Center for Drug Evaluation and Research, told reporters.
The FDA said the labels of the drugs failed to warn consumers of dangerous interactions if taken with other medications, including some HIV drugs, antibiotics and anti-fungal agents.
There are five ergotamine tartrate drugs on the market that have FDA approval, including one made by Sandoz. The labels of those approved medications carry "black-box" warnings, the most severe the government can require, about the risk of drug interactions.
The FDA stepped up last year its efforts to get drugs without agency approval off the market. Under guidelines issued in June, the FDA said those unapproved drugs most likely to pose a risk to public health would be the highest priority for enforcement action. ------------------------------------------------------------------ March 2, 2007
Don't Let your Jewelry KILL you !
That magnetic brooch or necklace may set off more than your eyes or sweater-it could also set off, or turn off, your pacemaker or implanted cardioverter/defibrillator(ICD).
Jewelry, reading glasses, name tags, and even some clothing now sport a new breed of magnet. Called rare earth or neodymium-iron-boron magnets, they are more powerful than the traditional magnets used to stick things to a refrigerator or found inside stereo speakers
Swiss researchers tested two jewel-sized pieces as well as a necklace and a name tag-all made of neodymium-iron- boron magnets-in 70 volunteers with a pacemaker or ICD. All four pieces interfered with the heart device at a distance of an inch or so. They made the pacemakers generate “beat now” signals at a fixed rate regardless of the heart’s activity. More worrisome, they turned off the ICD’s ability to detect and stop a potentially deadly heart rhythm.
People with pacemakers and ICDs are advised to keep magnets a least a few inches from their device. That’s generally not a problem, but these new magnets are showing up in products that can potentially sit right on top of the device. --------------------------------------------------------------
February 16, 2007
Researchers offer hope for stroke victims with vision impairments
A new device that uses light stimulation could help enlarge the visual field of stroke victims who have been left with vision impairments, according to researchers.
The visual field of about three quarters of the patients treated using Vision Restoration Therapy improved on average by nearly 15%. These patients suffered a stroke or other brain injury causing impaired vision. The complete Vision Restoration Therapy program, a custom-designed pattern of bright and dim light stimulation, delivered to the edges of the visual field of the affected eye, consists of six four-week treatment modules.
For some, the improvement may make the difference between not reading and having the ability to read. The research results were presented during the American Stroke Association's International Stroke Conference 2007 in San Francisco. The findings are being used to seek approval for Medicare reimbursement for the device, according to researchers. --------------------------------------------------------------------
February 11, 2007
Lucentis Linked to Stroke Risk in Elderly
January 30, 2007 — Genentech, Inc, has warned healthcare professionals regarding the potential increased risk for stroke associated with use of ranibizumab ( Lucentis) in the treatment of neovascular (wet) age-related macular degeneration in elderly patients. The warning was based on interim data from an ongoing safety study (SAILOR) showing that the risk for stroke was significantly higher in patients receiving the recommended dose of ranibizumab (0.5 mg) compared with a 0.3 mg dose (1.2% vs 0.3%; P = .02) at an average follow-up of 230 days. Patients with a history of stroke appeared to be at increased risk for subsequent stroke, the company said. The 0.3- and 0.5-mg doses were not statistically different in terms of incidence of myocardial infarction or vascular death, and their overall safety appeared to be consistent with that observed in phase 3 studies submitted as part of the drug approval process. Ranibizumab was approved by the US Food and Drug Administration in June 2006. The recommended dosing regimen is 0.5 mg administered by intravitreal injection once a month. Additional information regarding use of ranibizumab injection may be obtained from the company by calling 1-800-821-8590.Adverse events potentially related to use of ranibizumab should be reported to the company by phone at 1-888-835-2555. Alternatively, this information may be communicated to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. --------------------------------------------------------------------- February 10, 2007
Lonely adults twice as likely to develop Alzheimer’s disease, researchers find: Social and emotional isolation in elderly people increase their risk of developing dementia by about 51%, according to new research.
The risk of developing Alzheimer’s disease among 823 elderly people was about twice as great in subjects who reported a high degree of loneliness, said researchers at Rush University Medical Center in Chicago. They studied participants for four years.
Social isolation in old age includes being single, having few friends and participating in few activities with others, researchers said in their study report. They also note that it seems unlikely that dementia causes loneliness, because loneliness levels remained relatively stable even in subjects who developed dementia. The study appears in the Archives of General Psychiatry. ---------------------------------------------------------------
February 9, 2007
Study: Older adults can handle bad news better than younger people
A new study has uncovered revealing findings about perception and age: Older people, investigators found, can take bad news better than their children or grandchildren. As a result, they can be more risky gamblers because losses don’t affect them as much.
Older adults process negative information differently from their younger counterparts, according to research funded by the National Institute on Aging. They respond less strongly to unpleasant information.
When they were shown a series of images, including dead animals and ice cream, they were less likely to be depressed and affected by negative or unpleasant information. They also were less likely to react to gambling losses. Still, their lack of responsiveness did not make them any happier, said lead researcher Dr. Stacey Wood, neuropsychologist and associate professor at California's Scripps College. ------------------------------------------------------------------
February 8, 2007
Elderly women with kidney disease at greater risk of hip fractures
Even mild kidney dysfunction in elderly women raises their risk of hip fracture, according a new study.
Researchers at the VA Medical Center in Minneapolis found that mildly impaired kidney function increased the risk of hip fracture among older women by more than 50%. Moderately impaired kidney function increased the risk of hip fractures by more than 100%. Researchers studied nearly 700 women 65 and older, either with hip fractures, vertebral fractures or no broken bones.
Kidney function did not have an effect on vertebral fractures, according to the research. The study was published in the Archives of Internal Medicine. --------------------------------------------------------------------------
February 7, 2007
Lucentis Linked to Stroke Risk in Elderly
January 30, 2007 — Genentech, Inc, has warned healthcare professionals regarding the potential increased risk for stroke associated with use of ranibizumab (Lucentis) in the treatment of neovascular (wet) age-related macular degeneration in elderly patients.The warning was based on interim data from an ongoing safety study (SAILOR) showing that the risk for stroke was significantly higher in patients receiving the recommended dose of ranibizumab (0.5 mg) compared with a 0.3 mg dose (1.2% vs 0.3%; P = .02) at an average follow-up of 230 days. Patients with a history of stroke appeared to be at increased risk for subsequent stroke, the company said. The 0.3- and 0.5-mg doses were not statistically different in terms of incidence of myocardial infarction or vascular death, and their overall safety appeared to be consistent with that observed in phase 3 studies submitted as part of the drug approval process. Ranibizumab was approved by the US Food and Drug Administration in June 2006. The recommended dosing regimen is 0.5 mg administered by intravitreal injection once a month. Additional information regarding use of ranibizumab injection may be obtained from the company by calling 1-800-821-8590.Adverse events potentially related to use of ranibizumab should be reported to the company by phone at 1-888-835-2555. Alternatively, this information may be communicated to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. --------------------------------------------------------------------
January 26, 2007
Lyrica (pregabalin) Problems
The FDA Medical Officer who was the primary reviewer for the applications for approval of pregabalin for diabetic neuropathy and postherpetic neuralgia concluded that the drug should not be approved for these indications. Concerning the application for postherpetic neuralgia, he stated that "overall the risk of adverse effects of treatment approach or exceed the likelihood of treatment benefit." In similarly recommending against the approval for diabetic neuropathy, he stated that "it does not appear that the benefits of the drug in patients with diabetic neuropathy outweigh the risks. I therefore do not recommend approval of this application."
His concerns about risks involved statistically significant increases in visual abnormalities in patients using pregabalin as well as increased numbers of accidental injuries and edema. For blurred vision, there was a 4.3-fold increase in pregabalin users compared with those taking a placebo and for double vision, a 6.7 fold increase. Accidental injuries occurred nine times more frequently in pregabalin users. One possible explanation for the increased injuries is significant increases in dizziness and abnormal gait in people using pregabalin.
Despite the concerns of the FDA Medical Officer, he was overruled by his supervisors and the drug was approved for these two indications. After its approval, one review of the drug's performance rated the evidence for pregabalin for neuropathic pain as limited.
Pregabalin may control, but does not cure, these conditions, nor any off-label conditions for which it may be prescribed. It belongs to the same family as gabapentin (NEURONTIN), a drug that was illegally promoted for many off-label uses despite a lack of evidence of its effectiveness.
DO NOT USE Until 2012: Pregabalin for Partial-Onset Seizures
Pregabalin was approved as an adjuvant treatment for partial-onset seizures, meaning it can be used along with other anti-seizure medications such as carbamazepine, lamotrigine, phenytoin, or valproate in order to increase their overall effectiveness.
Many patients who experience partial-onset seizures have inadequate response to available drugs. Up to 12 percent of adults facing this condition may become seizure free with pregabalin.
Concerns When Taking Pregabalin
Adverse effects, including muscle twitches, happen more with higher doses. Pregabalin may decrease platelets or cause you to retain fluid. Common adverse effects include dizziness, vision changes, and weight gain. This drug is a controlled substance with a potential for abuse.
In March 2006, evidence of erectile dysfunction in five men using pregabalin was published in a journal article co-authored by a researcher from Pfizer, manufacturer of both pregabalin and VIAGRA. In the report are previously unpublished Pfizer data showing significant increases, compared to a placebo, in sexual dysfunction in both men and women using pregabalin. For men, there were significant increases in impotence and decreased libido. For women, there were significant increases in anorgasmia (failure to have an orgasm) and decreased libido.
Patients taking pregabalin should start with the lowest recommended dose. If necessary, the prescribing physician should increase the dose gradually. Be advised that it takes at least one week to experience a decrease in pain. For neuropathic pain, doses of 600 mg have more adverse effects and no additional benefit occurs compared to doses of 300 mg. People with kidney problems or on dialysis may need dose adjustments. If stopping, follow your doctor's instructions to lower the dose of pregabalin gradually over a week. Otherwise, seizures may occur. There have been reports of brain swelling due to abrupt stopping of pregabalin.
See the complete review of LYRICA here: http://www.worstpills.org/member/drugprofile.cfm?m_id=312 ------------------------------------------------------------------------
January 19,2007
Effect of 3-year folic acid supplementation on cognitive function in older adults in the FACIT trial: a randomised, double blind, controlled trialSummary
Background Low folate and raised homocysteine concentrations in blood are associated with poor cognitive performance in the general population. As part of the FACIT trial to assess the effect of folic acid on markers of atherosclerosis in men and women aged 50–70 years with raised plasma total homocysteine and normal serum vitamin B12 at screening, we report here the findings for the secondary endpoint: the effect of folic acid supplementation on cognitive performance. Methods Our randomised, double blind, placebo controlled study took place between November, 1999, and December, 2004, in the Netherlands. We randomly assigned 818 participants 800 μg daily oral folic acid or placebo for 3 years. The effect on cognitive performance was measured as the difference between the two groups in the 3-year change in performance for memory, sensorimotor speed, complex speed, information processing speed, and word fluency. Analysis was by intention-to-treat. This trial is registered with clinicaltrials.gov with trial number NCT00110604. Findings Serum folate concentrations increased by 576% (95% CI 539 to 614) and plasma total homocysteine concentrations decreased by 26% (24 to 28) in participants taking folic acid compared with those taking placebo. The 3-year change in memory (difference in Z scores 0·132, 95% CI 0·032 to 0·233), information processing speed (0·087, 0·016 to 0·158) and sensorimotor speed (0·064, −0·001 to 0·129) were significantly better in the folic acid group than in the placebo group. Interpretation Folic acid supplementation for 3 years significantly improved domains of cognitive function that tend to decline with age.
Affiliations
a. Division of Human Nutrition, Wageningen University, 6700 EV Wageningen, Netherlands b. Wageningen Centre for Food Sciences, Wageningen, Netherlands c. Department of Psychiatry and Neuropsychology, Brain and Behaviour Institute, Maastricht University, Maastricht, Netherlands
------------------------------------------------------ January 15, 2007
New gene linked to Alzheimer's, data
Researchers identified a new gene that may be linked to late-onset Alzheimer's disease. The findings are published in the current issue of Nature Genetics.
In the study, researchers examined DNA samples from 6000 people with different ethnic backgrounds. The results showed that certain variations of the SORL1 gene occurred more often in people with late-onset Alzheimer's disease than in healthy people. The researchers also remarked that SORL1 appears to affect how amyloid beta protein builds up in brain cells, which many scientists believe plays a key role in causing Alzheimer's.
Study co-author and University of Toronto researcher Dr. Peter St. George-Hyslop indicated that "what we found is this gene is robustly associated with increased risk for common forms of late-onset Alzheimer's disease in several different ethnic groups. [The gene] is likely to be a significant contributor to the causes of Alzheimer's," he said, The Toronto Star reports.
Meanwhile, Dr. Sam Gandy, chairman of the American Alzheimer's Association medical and scientific advisory council, noted that although SORL1 probably does not play as much of a role in the onset of Alzheimer's as previous genetic discoveries, "it does dovetail with the main hypothesis for how Alzheimer's starts. It tells us we are on the right track with drug discovery efforts." -------------------------------------------------------------------
January 3, 2007
Parkinson's Drugs Linked to Heart Problem Publication date: 2007-01-03
The use of common agents used in treating Parkinson's disease may be associated with a heart-valve abnormality, European researchers say.
Researchers said Wednesday they found that 12 of 31 patients newly diagnosed with a heart-valve regurgitation -- a failure of the valve to operate correctly -- were taking either pergolide (Permax) or cabergoline (Dostilex), medicine used in treating patients with Parkinson's symptoms or other conditions such as restless leg syndrome.
In a companion study that will also be published in Thursday's editions of the New England Journal of Medicine, researchers in Milan, Italy, also discovered that patients taking either of the drugs had elevated rates of heart-valve regurgitation.
About 23 percent of those on pergolide and 28 percent of those on cabergoline showed evidence of serious heart-valve regurgitation compared with 5.6 percent of other patients who were on a different class of Parkinson's drug or who were not taking any anti-Parkinson's medication.
There was no evidence of such an increase in risk with the use of other dopamine agonists (used in treating Parkinson's disease), said Rene Schade, a clinical pharmacologist at Charite-University Hospital in Berlin, Germany.
The Italian researchers suggested that follow-up echocardiograms be performed on patients being treated with the drugs. ---------------------------------------------------------------------
December 2006

Merry Christmas and Happy New Year!
November 29, 2006
METHADONE -- Death, Narcotic Overdose, and Serious Cardiac ArrhythmiasFDA has reviewed reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone’s cardiac toxicities (QT prolongation and Torsades de Pointes). Physicians prescribing methadone should be familiar with methadone’s toxicities and unique pharmacologic properties. Methadone’s elimination half-life (8-59 hours) is longer than its duration of analgesic action (4-8 hours). Methadone doses for pain should be carefully selected and slowly titrated to analgesic effect even in patients who are opioid-tolerant. Physicians should closely monitor patients when converting them from other opioids and changing the methadone dose, and thoroughly instruct patients how to take methadone. Healthcare professionals should tell patients to take no more methadone than has been prescribed without first talking to their physician. Considerations Methadone is an effective analgesic and may provide pain relief when other analgesics are ineffective. However, methadone can cause significant toxicities. We are highlighting important safety information from the new label about using methadone for pain. See the methadone label (Dolophine) for more details. Methadone’s elimination half-life (8-59 hours) is longer than its duration of analgesic action (4-8 hours). Methadone’s peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects. During treatment initiation, methadone’s full analgesic effect is usually not attained until 3-5 days of dosing. Initiation and titration to analgesic effect and dose adjustments should be done cautiously and in consideration of these properties. In chronic use, methadone may be retained in the liver and then slowly released, prolonging the duration of action despite low plasma concentrations. Cross-tolerance between methadone and other opioids is incomplete. This incomplete cross-tolerance makes the conversion of patients on other opioids to methadone complex and does not eliminate the possibility of methadone overdose, even in patients tolerant to other opioids. Deaths have been reported during conversion from chronic, high-dose treatment with other opioid agonists to methadone. It is critical to understand the pharmacokinetics of methadone when converting patients from other opioids to methadone. Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose adjustments. Methadone can cause serious cardiac conduction effects, including QT interval prolongation and Torsades de Pointes. There are pharmacokinetic and pharmacodynamic drug interactions between methadone and many other drugs. Drugs administered concomitantly with methadone should be evaluated for interaction potential. Methadone is secreted into human milk. What should physicians do?
- Read and follow the prescribing information for methadone.
- Carefully weigh methadone’s risks with its potential benefits before prescribing methadone.
- Avoid prescribing methadone 40 mg dispersible tablets for pain. This product is only FDA-approved for detoxification and maintenance treatment of narcotic addition.
- Closely monitor patients who receive methadone, especially during treatment initiation and dose adjustments.
What should healthcare professionals tell patients when prescribing methadone for pain?
- Pain relief from methadone does not last as long as methadone stays in your body. Therefore, do not to take more methadone than prescribed because methadone could build up in your body and cause death.
- Methadone can cause life-threatening changes in breathing (it may slow or stop).
- Methadone can cause life-threatening changes to the heart beat that may not be felt.
- Seek medical attention right away if you experience symptoms suggestive of an arrhythmia such as palpitations, dizziness, lightheadedness, or fainting or if you experience symptoms suggestive of a methadone overdose such as slow or shallow breathing; extreme tiredness or sleepiness; blurred vision; inability to think, talk or walk normally; and feeling faint, dizzy or confused.
- Directions you should follow if your pain is not controlled after taking the prescribed amount of methadone.
- Pain relief from methadone should last longer after you have taken it for awhile.
- Tell your doctor if you start or stop other medicines because other medicines can interact with methadone and possibly cause death or life threatening side effects, or result in less pain relief from methadone.
- Tell your doctor if you are breastfeeding because methadone is secreted into human milk. Babies can experience the same serious side effects from methadone as the mother.
Data and Background Information There have been reports of serious adverse events such as death, respiratory depression, and serious cardiac arrhythmias in patients receiving methadone. Fatalities have been reported in patients who were switched from chronic, high-dose treatment with other opioids to methadone and in patients initiating treatment with methadone. These adverse events may have resulted from unintentional methadone overdoses, drug interactions, and/or methadone’s cardiac toxicities (QT prolongation and Torsades de Pointes). Some of the unintentional overdoses were due to prescribers not being aware of methadone’s pharmacokinetics and potential adverse effects. FDA recently updated the methadone label following an extensive review of the medical literature and other available information. The new label provides new information on methadone’s pharmacology, drug interactions, and instructions on converting patients from other opioids to methadone and dosing methadone based on a synthesis of recommendations from several palliative care organizations and treatment centers. ----------------------------------------------------------------- November 13, 2006
FDA staff recommends updating Tamiflu label over neuropsychiatric events
FDA staff recommended that a advisory committee consider updating the label for Roche's Tamiflu, to caution that there have been postmarketing reports of neuropsychiatric events in patients who have taken the antiviral drug. The recommendations were posted to the US agency's Web site ahead of a paediatric advisory committee meeting scheduled for November 16. In a briefing document dated September 20, the US regulatory staff noted that between August 29, 2005 and July 6, 2006, 103 cases of neuropsychiatric events have been reported in people who received Tamiflu. The agency staff said that about 67 percent of cases occurred in U.S. patients, and 95 out of the 103 cases came from Japan. As a result, the agency staff suggested that the drug's precautions section be updated to state that people receiving treatment with Tamiflu, particularly children, geriatric and adolescent patients, should be "monitored closely" for abnormal behaviour such as hallucinations, delusions, aggression and suicidal ideation. --------------------------------------------------------------------
November 12, 2006
Polypharmacy and Prescribing Quality in Older People
In a recent study published in the Journal of the American Geriatrics Society, researchers found that both inappropriate use and underuse of medications are evident among 40% of older patients taking five or more medications. Vitamins and minerals, topical and herbal products, and as-needed medications were all excluded from the study. To determine appropriateness, researchers used the 2003 update of the Beers’ criteria and subscales of the Medication Appropriateness Index. The mean age of study participants was 74.6, and patients used a mean of 8.1 ± 2.5 medications (range 5-17). Use of one or more inappropriate medications was documented in 128 patients (65%), including 73 (37%) taking a medication in violation of the Beers drugs-to-avoid criteria and 112 (57%) taking a medication that was ineffective, not indicated, or duplicative. Medication underuse was observed in 125 patients (64%). Together, inappropriate use and underuse were simultaneously present in 82 patients (42%), whereas 25 (13%) had neither inappropriate use nor underuse. When assessed by the total number of medications taken, the frequency of inappropriate medication use rose sharply from a mean of 0.4 inappropriate medications in patients taking five to six drugs, to 1.1 inappropriate medications in patients taking seven to nine drugs, to 1.9 inappropriate medications in patients taking 10 or more drugs. In contrast, the frequency of underuse averaged 1.0 underused medications per patient and did not vary with the total number of medications taken. Overall, patients using fewer than eight medications were more likely to be missing a potentially beneficial drug than to be taking a medication considered inappropriate. ----------------------------------------------------------------
November 12, 2006
CDC Advisory Panel Votes to Recommend New Shingles Vaccine for Vaccination of Adults Age 60 and Older The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recently voted unanimously to recommend that adults 60 years of age and older be vaccinated with Zostavax® to help prevent shingles (herpes zoster). Zostavaxâ was approved by the U.S. Food and Drug Administration (FDA) on May 25 for the prevention of shingles in individuals 60 years of age and older. Zostavaxâ is given by a single dose by injection. The ACIP recommendations do not result in requirements for vaccine coverage by insurers; however, private insurers typically follow the Committee’s guidance. Details of the ACIP recommendations for Zostavaxâ soon will be available from the CDC. The recommendations are under review by the director of the CDC and the Department of Health and Human Services and will become official when published in the CDC's Morbidity and Mortality Weekly Report. --------------------------------------------------
November 11, 2006
Evaluating Risks of Surgery for Sleep Apnea
Individuals with obstructive sleep apnea repeatedly stop breathing during the night due to upper airway obstruction. This condition is very common, as common as adult diabetes, and affects more than 12 million Americans, according to the National Institutes of Health. Risk factors include being male, overweight and over the age of 40, but sleep apnea can strike anyone at any age, even children.
Untreated, sleep apnea can cause high blood pressure and other cardiovascular disease, memory problems, weight gain, impotence, headaches and even death. Moreover, untreated sleep apnea may be responsible for job impairment and motor vehicle accidents.
Although the risk of serious complication following corrective surgery for sleep apnea is relatively low, the surgery is more risky in certain groups of patients with other medical problems, high body mass index (a measure of obesity) and more severe obstructive sleep apnea, according to a study led by UCSF Assistant Professor in Residence Eric J. Kezirian, MD, MPH, in the October issue of Archives of Otolaryngology – Head and Neck Surgery, published by the Journal of the American Medical Association.
A procedure known as uvulopalatopharyngoplasty (UPPP), during which surgeons remove the uvula and other soft tissues at the back of the throat to help clear the airway, is the most common operation performed to alleviate sleep apnea. Earlier work from Kezirian and his colleagues had shown that about 1.6 percent of all patients undergoing such procedures have serious complications, including 0.2 percent who die within 30 days. Previous reports about the risk factors for complications had been conflicting.
In Kezirian and his colleagues’ latest research, they studied 3,130 patients who underwent UPPP between 1991 and 2001 at United States Veterans Affairs medical centers. The researchers utilized data about participants’ surgeries and characteristics from medical records.
Data on body mass index, other illnesses and the severity of sleep apnea were collected from the medical charts of a smaller group of patients, including 51 (1.6 percent) who had serious complications and 212 others who did not have serious complications, but were the same sex and age, had the same number of procedures performed at the same time and had surgery the same year as those who did have serious complications.
In the larger group of 3,130 patients, the most important risk factor for serious complication was the presence of other serious medical conditions at the time of surgery. For each additional serious illness – besides sleep apnea – that a patient had, his or her risk for complications almost doubled. In the smaller group of patients, more severe sleep apnea, higher body mass index and the presence of other illnesses were associated with a higher risk for complication.
“While most patients do not have complications following sleep apnea surgery, it is important to know which patients may be at greatest risk,” Kezirian said. “I hope this research will improve the ability of surgeons to discuss the potential risks with patients and, in many cases, take additional steps or precautions to make the surgery even safer.”
" Risk Factors for Serious Complications After Uvulopalatopharyngoplasty " Eric J. Kezirian, MD, MPH; Edward M. Weaver, MD, MPH; Bevan Yueh, MD, MPH; Shukri F. Khuri, MD; Jennifer Daley, MD; William G. Henderson, PhD Archives of Otolaryngology – Head and Neck Surgery October 2006;132:1091-1098 -----------------------------------------------------------------
November 10, 2006
Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study
Summary Background
Lifestyle interventions can prevent the deterioration of impaired glucose tolerance to manifest type 2 diabetes, at least as long as the intervention continues. In the extended follow-up of the Finnish Diabetes Prevention Study, we assessed the extent to which the originally-achieved lifestyle changes and risk reduction remain after discontinuation of active counselling. Methods Overweight, middle-aged men (n=172) and women (n=350) with impaired glucose tolerance were randomly assigned to intensive lifestyle intervention or control group. After a median of 4 years of active intervention period, participants who were still free of diabetes were further followed up for a median of 3 years, with median total follow-up of 7 years. Diabetes incidence, bodyweight, physical activity, and dietary intakes of fat, saturated fat, and fibre were measured. Findings During the total follow-up, the incidence of type 2 diabetes was 4·3 and 7·4 per 100 person-years in the intervention and control group, respectively (log-rank test p=0·0001), indicating 43% reduction in relative risk. The risk reduction was related to the success in achieving the intervention goals of weight loss, reduced intake of total and saturated fat and increased intake of dietary fibre, and increased physical activity. Beneficial lifestyle changes achieved by participants in the intervention group were maintained after the discontinuation of the intervention, and the corresponding incidence rates during the post-intervention follow-up were 4·6 and 7·2 (p=0·0401), indicating 36% reduction in relative risk. Interpretation Lifestyle intervention in people at high risk for type 2 diabetes resulted in sustained lifestyle changes and a reduction in diabetes incidence, which remained after the individual lifestyle counselling was stopped.
October 29, 2006
Doctors Prescribing Medications without explaining effects to patient
Many doctors, a new study reports, prescribe medicine without explaining its purpose, discussing its side effects, offering instructions about its use or even mentioning its name.
Researchers audiotaped 45 doctors during their encounters with 909 patients, identifying 185 visits in which 243 medications that had not been used before by the patient were prescribed. The average age of the patients was 55, half of them were men, and most had some college education. Almost all had health insurance. About three-quarters of the doctors were men, and 89 percent were white.
Although there were variations, depending on the type of medicine prescribed, 74 percent of the doctors mentioned the trade or generic name of the medicine, and 87 percent stated its purpose. Sixty-six percent said nothing about how long to take the medicine, 45 percent did not say what dosage to take and 42 percent failed to mention the timing or frequency of doses. Physicians mentioned adverse side effects only 35 percent of the time.
The authors noted that the results may not be applicable to other groups of patients, and that the presence of recording equipment may have influenced what doctors said during the patient visits.
Still, Dr. Neil S. Wenger, the senior author on the study, said, “The problems we’re seeing are exactly the things we see going wrong in clinical practice.
“You prescribe a cholesterol-lowering medicine, a medicine that has to be taken for a lifetime, and the person never refills the first prescription. And we wonder why. Now it’s clear why: we never told them that they were supposed to keep taking it.”
Dr. Wenger is a professor of medicine at the University of California, Los Angeles.
The study was published Sept. 25 in Archives of Internal Medicine.
Correction: Oct. 4, 2006
A report in the Vital Signs column in Science Times yesterday, about a study that says many doctors prescribe medicine without giving patients basic information, omitted the journal that published the study. It was The Archives of Internal Medicine. -------------------------------------------------------------------
October 25, 2006
Adverse Drug Events an Important Cause of Illness: Report
NEW YORK (Reuters Health) Oct 18 - Each year, an estimated 700,000 Americans experience adverse reactions to prescribed drugs that necessitate a trip to the emergency department (ED), according to a report in the October 18th issue of the Journal of the American Medical Association. "Adverse drug events among outpatients that lead to emergency department visits are an important cause of morbidity in the United States, particularly among individuals aged 65 years or older," write Dr. Daniel S. Budnitz, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. During the two-year period from January 1, 2004 to December 31, 2005, a total of 21,298 adverse drug event (ADEs) cases were reported to a national surveillance system, yielding weighted annual estimates of 701,547 persons, or 2.4 persons per 1000 population, treated in EDs for adverse drug reactions. Adverse drug events included allergic reactions, unintended overdoses, adverse effects, secondary effects, and vaccine reactions. Such events accounted for 2.5% of estimated ED visits for all unintentional injuries and 6.7% of estimated ED visits leading to hospitalization. Adverse drug events were also responsible for 0.6% of estimated ED visits for all causes. Individuals aged 65 and older, who make up 12% of the US population, accounted for 25% of adverse drug events overall, and half of these events required hospitalization. This "highlights the importance of directing ADE prevention efforts to this vulnerable population," the authors write. Emergency department visits for ADEs in individuals 65 and older were nearly as common as those for motor vehicle occupant injuries, Dr. Budnitz and colleagues point out. Most ADEs were the result of unintentional overdoses and involved acute toxicity from drugs requiring regular outpatient monitoring such as antidiabetic agents, warfarin, several anticonvulsants, digitalis, glycosides, theophylline, and lithium. "Ongoing, population-based surveillance can help monitor these events and target prevention strategies," Dr. Budnitz and colleagues conclude. JAMA 2006;296:1858-1866. -------------------------------------------------------------------
October 22, 2006
Tamoxifen Should I or Shouldn't I Use???
Post-menopausal women who take tamoxifen to treat breast cancer face a greater risk of recurrence if they have a specific genetic variation, federal health advisers said Wednesday in recommending that a warning be added to the drug's label.
Recent studies have found tamoxifen does not work as well in women with breast cancer who carry a variant of a gene called CYP2D6. An estimated 7 percent to 10 percent of women with breast cancer may have that special form of the gene, which affects how their bodies process the drug.
A panel of Food and Drug Administration advisers recommended the agency change tamoxifen's label to warn post-menopausal women of that potential risk.
"The bottom line is, the consensus was that the information is important enough to be included in the label," said FDA pharmacology chief Dr. Lawrence Lesko.
However, the clinical pharmacology panel left it to the FDA to decide whether the drug's label should recommend genetic testing of post-menopausal breast cancer patients before they are prescribed tamoxifen. Still, the FDA will consider adding such language - perhaps in the form of a suggestion - to the label, Lesko said.
The FDA first approved tamoxifen in 1977. It is made in generic form by multiple drug companies.
The drug is now use to both treat breast cancer and to prevent the disease in women who may be predisposed to it. The drug blocks estrogen, a hormone that stimulates the growth of most tumors after menopause.
Lesko said the label changes could take six months to put in place. Since 2003, the FDA has taken three other drugs before the panel to discuss adding genetic-specific information to their labels. They include the blood-thinner warfarin; updates to its label are forthcoming, Lesko said. So to be on the safe side if Tamoxifen (Nolvadex) is prescribed for you, as a cancer prophylaxis treatment, I would definitely ask the physician to run the genetic test necessary to determine the safety of the use of this drug. ------------------------------------------------------------------------
October 20, 2006
Few Older Patients Get Appropriate Drugs
Doctors are as likely to under-prescribe medications for elders as they are to over-prescribe, say researchers at the San Francisco VA Medical Center.
Forty-two percent of patients studied were taking at least one inappropriate medication and simultaneously not taking one or more other medications that could have helped them, according to lead author Dr. Michael Steinman.
It's not just a question of, 'are you taking too much or too little,' physicians need to look at both sides of the equation, and be attentive to different kinds of prescribing problems.
The researchers observed 196 outpatients -- 194 of them male -- ages 65 or older who were taking five or more prescribed medications and receiving care at a Veterans Affairs Medical Center.
Sixty-five percent of patients were taking a drug that was ineffective, not indicated, duplicative of another medication, or considered generally inappropriate for older persons. Sixty-four percent were not taking a drug that would have been appropriate for a medical condition they had.
Together, 42 percent were simultaneously taking an inappropriate drug and not taking an appropriate drug. Only 13 percent were taking all drugs appropriate for their conditions and not taking inappropriate drugs, according to the study published in the Journal of the American Geriatrics Society. ------------------------------------------------------------------------
October 14, 2006
Study: Common blood-thinning drug weakens bones; Patients on Coumadin suffer more fractures
Older patients who take a common blood-thinner are more likely to suffer broken bones, according to a new study at Washington University here.
The study found that people taking warfarin, also known by the brand-name Coumadin, had an increased risk of fractures linked to osteoporosis. The results suggest doctors should carefully monitor the bone health of patients on the drug and that patients should take steps to reduce their risk.
Warfarin is often given to patients with atrial fibrillation, which is characterized by irregular contractions of the heart's upper chambers. By interfering with the role of vitamin K in clotting, the drug reduces the risk of blood clots, which often are caused by atrial fibrillation.
But vitamin K also aids osteocalcin, a protein vital for bone formation. As a result, warfarin also can affect bone strength, causing fractures to occur more easily.
"Our analysis showed that long-term use of warfarin -- longer than one year -- led to a 25 % increase in the incidence of fracture," said the study's lead author, Dr. Brian Gage, who studied the records of 15,000 patients hospitalized with atrial fibrillation.
The numbers were particularly alarming for men. Males who took warfarin for more than a year had a 63 % higher incidence of fracture than men who did not take the blood thinner. Elderly women, who normally have a higher risk of fractures, did not see their risk rise significantly on long-term warfarin use, Gage said.
Patients taking warfarin for less than one year did not have increased fracture risk. Patients taking beta-blockers also had fewer broken bones. The average age of patients studied was 80.
"The results of the study have important implications for the treatment of atrial fibrillation," said Gage, medical director of Barnes-Jewish Hospital's Blood Thinner Clinic.
"To maintain bone strength, elderly patients taking warfarin should exercise regularly and have adequate intakes of calcium and vitamin D. Those who are prone to falling could use walking aids and proper footwear. Smokers should quit."
More than half of the fractures seen in the study were hip fractures; the rest involved the spine and wrist. In the study group, nearly two of every five patients with a hip fracture died within 30 days. Gage said he hopes anticoagulants can be developed that will not interfere with vitamin K. ----------------------------------------------------------------------------------------
October 12, 2006
NICE rejects appeals related to appraisal of Alzheimer's drugs
NICE announced Wednesday that the appeals lodged by drugmakers and advocacy groups against draft guidance on the use of drugs to treat Alzheimer's disease have been rejected. NICE will recommend to the NHS in November that Pfizer's and Eisai's Aricept (donepezil), Johnson & Johnson's and Shire's Reminyl (galantamine) and Novartis' Exelon (rivastigmine), should be made available only for patients with moderate Alzheimer's disease.
Additionally, the agency recommended that Lundbeck's Ebixa (memantine) should only be given in clinical trials to patients with moderately-severe to severe Alzheimer's. NICE's chief executive Andrew Dillon explained that "based on all the evidence, including data presented by the drug companies themselves, our experts have concluded that these drugs do not make enough of a difference for us to recommend their use for all stages of Alzheimer's."
In response, drugmakers Shire and Lundbeck said in separate statements that they disagree with the ruling. Eisai and Pfizer noted that they are considering whether to appeal the decision. Meanwhile, Eisai's managing director, Dr. Paul Hooper, commented that "NICE is saying [to] wait until patients deteriorate before you treat them. It makes no sense medically, it makes no sense economically and it makes no sense to patients and their carers," The Daily Mail reports.
A statement released by the Association of the British Pharmaceutical Industry indicated that the organisation "condemns" the decision, noting that NICE's guidance "makes it harder for companies to justify devoting the enormous sums of money and resource necessary to research and develop new medicines, especially for conditions such as Alzheimer's, where there is so much more to be discovered about how best to treat it." ------------------------------------------------------------------------
October 11, 2006
If you are taking Coumadin (Warfarin) you should print this out....
The FDA has the regulatory authority to require the distribution of Medication Guides by pharmacists for drugs that pose a serious and significant public health concern. However, at this time, there are only approximately 75 drugs that require Medication Guides out of the thousands of drugs on the market. A list of these drugs with links to their respective Medication Guides can be found on the FDA's Web site at: http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.
The new warfarin Medication Guide is reproduced below.
What You Can Do
You should ask your pharmacist for a Medication Guide if you are currently taking warfarin. Look up the information concerning drug interactions on Worstpills.org.
Make sure you get a Medication Guide with each refill prescription for warfarin as it may contain new updated information.
MEDICATION GUIDE COUMADIN(COU-ma-din) Tablets (Warfarin Sodium Tablets, USP) Crystallin
Read this Medication Guide before you start taking COUMADIN (Warfarin Sodium) and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about COUMADIN when you start taking it and at regular checkups.
What is the most important information I should know about COUMADIN?
Take your COUMADIN exactly as prescribed to lower the chance of blood clots forming in your body. (See "What is COUMADIN?").
COUMADIN is very important for your health, but it can cause serious and life-threatening bleeding problems. To benefit from COUMADIN and also lower your chance for bleeding problems, you must:
Get your regular blood test to check for your response to COUMADIN. This blood test is called a PT/INR test. The PT/INR test checks to see how fast your blood clots. Your healthcare provider will decide what PT/INR numbers are best for you. Your dose of COUMADIN will be adjusted to keep your PT/INR in a target range for you.
Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems:
pain, swelling or discomfort headaches, dizziness, or weakness unusual bruising (bruises that develop without known cause or grow in size) nose bleeds bleeding gums bleeding from cuts takes a long time to stop menstrual bleeding or vaginal bleeding that is heavier than normal pink or brown urine red or black stools coughing up blood vomiting blood or material that looks like coffee grounds
Many other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements can interact with COUMADIN and:
affect the dose you need, or
increase COUMADIN side effects.
Tell your healthcare provider about all the medicines you take. Do not stop medicines or take anything new unless you have talked to your healthcare provider. Keep a list of your medicines with you at all times to show your healthcare provider and pharmacist.
Do not take other medicines that contain warfarin. Warfarin is the active ingredient in COUMADIN.
Some foods can interact with COUMADIN and affect your treatment and dose.
Eat a normal, balanced diet. Talk to your doctor before you make any diet changes. Do not eat large amounts of leafy green vegetables. Leafy green vegetables contain Vitamin K. Certain vegetable oils also contain large amounts of Vitamin K. Too much Vitamin K can lower the effect of COUMADIN.
Avoid drinking cranberry juice or eating cranberry products. Avoid drinking alcohol.
Always tell all of your healthcare providers that you take COUMADIN. Wear or carry information that you take COUMADIN.
What is COUMADIN?
COUMADIN is an anticoagulant medicine. It is used to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions such as blood clots in the legs or lungs.
Who should not take COUMADIN?
Do not take COUMADIN if:
your chance of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if COUMADIN is right for you.
Talk to your healthcare provider about all of your health conditions.
you are pregnant or plan to become pregnant. COUMADIN can cause death or birth defects to an unborn baby. Use effective birth control if you can get pregnant.
you are allergic to warfarin or to anything else in COUMADIN.
What should I tell my healthcare provider before starting COUMADIN?
Tell your healthcare provider about all of your health conditions, including if you:
have bleeding problems fall often have liver or kidney problems have high blood pressure have a heart problem called congestive heart failure have diabetes drink alcohol or have problems with alcohol abuse. Alcohol can affect your COUMADIN dose and should be avoided. are pregnant or planning to become pregnant. See "Who should not take COUMADIN?" are breastfeeding. COUMADIN may increase bleeding in your baby. Talk to your doctor about the best way to feed your baby. If you choose to breastfeed while taking COUMADIN, both you and your baby should be carefully monitored for bleeding problems.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. See "What is the most important information I should know about COUMADIN?"
How should I take COUMADIN?
Take COUMADIN exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to COUMADIN.
You must have regular blood tests and visits with your healthcare provider to monitor your condition.
Take COUMADIN at the same time every day. You can take COUMADIN either with food or on an empty stomach.
If you miss a dose of COUMADIN, call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of COUMADIN the next day to make up for a missed dose.
Call your healthcare provider right away if you take too much COUMADIN.
Call your healthcare provider if you are sick with diarrhea, an infection, or have a fever.
Tell your healthcare provider about any planned surgeries, medical or dental procedures. Your COUMADIN may have to be stopped for a short time or you may need your dose adjusted.
Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you.
What should I avoid while taking COUMADIN?
Do not start, stop, or change any medicine without talking with your healthcare provider.
Do not make changes in your diet, such as eating large amounts of green, leafy vegetables.
Do not change your weight by dieting, without first checking with your healthcare provider.
Avoid drinking alcohol.
Do not do any activity or sport that may cause a serious injury.
What are the possible side effects of COUMADIN?
COUMADIN is very important for your health, but it can cause serious and lifethreatening bleeding problems. See "What is the most important information I should know about COUMADIN?"
Serious side effects of COUMADIN also include: death of skin tissue (skin necrosis or gangrene). This can happen soon after starting COUMADIN. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
"purple toes syndrome." Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.
Other side effects with COUMADIN include allergic reactions, liver problems, low blood pressure, swelling, low red blood cells, paleness, fever, and rash. Call your healthcare provider if you have any side effect that bothers you.
These are not all of the side effects of COUMADIN. For more information, ask your healthcare provider or pharmacist.
How should I store COUMADIN?
Store COUMADIN at room temperature between 59° and 86° F. Protect from light.
Keep COUMADIN and all medicines out of the reach of children.
General Information about COUMADIN
Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use COUMADIN for a condition for which it was not prescribed. Do not give COUMADIN to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about COUMADIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COUMADIN that was written for healthcare professionals.
If you would like more information, call 1-800-321-1335.
Rx only
COUMADIN is distributed by: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA COUMADIN is a registered trademark of Bristol-Myers Squibb Pharma Company. COUMADIN (Warfarin Sodium), the COUMADIN color logo, COLORS OF COUMADIN, and the color and configuration of COUMADIN tablets are trademarks of Bristol-Myers Squibb Pharma Company.
**The brands listed (other than COUMADIN) are registered trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.
This Medication Guide has been approved by the U.S. Food and Drug Administration. --------------------------------------------------------------------
October 9, 2006
Update on Flu Vaccine
Remember that “Flu Season“ starts around the first of December and extends till the end of March. Once you receive the Flu Vaccine it takes about 30 days to build up the desired immunity. Therefore, NOW is the time to go get your Flu Shot. I encourage all to get the Vaccine late this month, October, or the first of next month, November, to be fully protected......................... Based upon the latest data from all influenza vaccine manufacturers, the Centers for Disease Control and Prevention (CDC) recently sent out an update and list of key messages to stakeholders regarding this year’s flu vaccine supply. Highlights include:
- There will be an estimated 100,000 doses of trivalent inactivated vaccine (TIV) and 3,000 doses of live attenuated influenza vaccine (LAIV). This is about 17,000 more doses than any previous season and 19,000 more than last year.
- GlaxoSmithKline’s FluLaval® vaccine is still awaiting licensure/approval.
- It is predicted that 75,000 doses will be distributed by the end of October. This is 15,000 more doses than was distributed last year at the same time.
- Shipments will continue through November and December. With the exception of FluLaval®, most manufacturers are striving to get all their doses out by the Thanksgiving holiday.
- The current recommendation is to encourage all to get vaccinated, especially those in contact with those at high-risk. The CDC also wants people to be vaccinated through December and beyond. The agency is encouraging providers to continue offering vaccination, even if influenza has already appeared in the community.
Sanofi pasteur announced that it has begun shipping influenza vaccine (Fluzone®) to the U.S. market for the 2006–2007 flu season. The shipment represents the first of approximately 50 million doses planned for production this year. As in previous years, the company will use a split-delivery process so that all customers will receive at least a partial delivery of their orders by the end of September. This process is used because it has been recognized as key to equitably distributing doses and facilitating the immunization of priority patients across the maximum number of providers. Shipments will continue until December. ------------------------------------------------------------------
October 6, 2006
Medicare Drug Plan Changes Affect Seniors
U.S. officials say changes in the Medicare prescription drug plan for next year will include more choices and better coverage especially in the doughnut hole.
More choices will allow beneficiaries in most states to choose from more than 50 plans and that the doughnut hole gap coverage will apply only to generic drugs, USA Today reported.
The newspaper said that currently the gap affects 94 percent of beneficiaries after they have paid about $750 until they reach $3,600 in costs. But health advocates say seniors should revisit the plan and re-examine the choices be cause of the changes.
The right plan for someone in 2006 might not be the right plan in 2007, a spokesman for the Kaiser Family Foundation health research organization told USA Today. The concern is that products are changing, but seniors won't.
Medicare officials say the average monthly premiums will stay below $24, or far less than the $37 originally projected. They said companies also are adding new forms of coverage.
Competition is working, Mark McClellan, administrator of the Centers for Medicare and Medicaid Services, told the newspaper. They are adding plans that people want. -----------------------------------------------------------------------
October 5, 2006
New findings over Vioxx risks published in JAMA
In a meta-analysis of studies involving COX-2 inhibitors, researchers found that Merck & Co.'s Vioxx (rofecoxib) was associated with an increased risk of renal problems and heart arrhythmia. In a separate analysis of previously published COX-2 inhibitor data, researchers suggest that the data showed that Vioxx increases the risk of cardiovascular events during the first 30 days of treatment.
In the first meta-analysis, Harvard researchers examined results from 114 trials of COX-2 inhibitors, involving a total of 116 094 patients, in an effort to identify risks of kidney-related problems and arrhythmia. According to the researchers, the results suggested that patients taking Vioxx had an increased risk of experiencing renal problems and heart arrhythmia compared to control groups.
Furthermore, the researchers concluded that there was no "class effect" because other COX-2 inhibitors examined in the analysis were "not significantly associated" with an increased risk of these problems. "Vioxx seems to increase renal and arrhythmia (risks) more than any of the other drugs," noted researcher Eric Ding, as reported in Morningstar.
In a separate study, researchers at the University of Newcastle in Australia reviewed data from controlled observational studies to compare the risks of serious cardiovascular events in patients who received COX-2 inhibitors or other NSAIDs. The researchers indicated that their findings confirm those from randomised trials regarding the cardiovascular risks associated with Vioxx, including an increased risk within one month of starting treatment.
JAMA published both study results online ahead of its scheduled publication date, due to the "public health implications" of the findings. ------------------------------------------------------------------
October 4, 2006
FDA Releases Alert Concerning Using Ibuprofen and Aspirin Together
On September 8 the Food and Drug Administration (FDA) notified consumers and health care professionals that taking ibuprofen and aspirin at the same time may interfere with the benefits of aspirin taken for the heart. The alert states that ibuprofen can interfere with the anti-platelet effect of low dose aspirin (81 mg per day), which may render aspirin less effective when used for cardio protection and stroke prevention. Although it is acceptable to use ibuprofen and aspirin together, FDA recommends that consumers contact their health care professional for more information about how to take these two medicines so they are effective. -------------------------------------------------------------------
October 3, 2006
Study: U.S. populations groups have life expectancy disparities
Asian Americans have an average life expectancy of 84.9 years, while low-income rual whites in the Midwest can expect to live 79 years. Meanwhile, black Middle Americans live, on average 72.9 years. This information appears in a study published in the journal PloS Medicine. Harvard University researchers analyzed population, mortality and health insurance statistics for 2,072 individuals and merged counties nationwide from 1982 to 2001. They offered statistics on eight groups based on genography, income and race. Differences in life expectancy among the groups are due largely to premature deaths of young and middle-aged adults, mainly as a result of chronic diseases or injuries. ---------------------------------------------------------------------
September 27, 2006
A Pharmacoepidemiology Study of the Interaction Between Atorvastatin (Lipitor) and Clopidogrel (Plavix) After Percutaneous Coronary Intervention
Posted 09/18/2006
James M. Brophy, MD, PhD; Mohan N. Babapulle, MD; Vania Costa, MSc; Stephane Rinfret, MD, MSc |
Abstract and IntroductionAbstractBackground: After percutaneous coronary intervention (PCI), the antiplatelet drug clopidogrel is frequently used to prevent stent thrombosis. A concern has been raised that atorvastatin may competitively inhibit the metabolism of the prodrug clopidogrel to its active metabolites by the cytochrome P450 3A4 (CYP3A4) enzyme, thereby potentially negating its antiplatelet effect. The 30-day rates of adverse cardiovascular events (composite of death, myocardial infarction, 11 unstable angina, stroke or transient ischemic attack, and repeat revascularization procedures) in unselected 12 patients prescribed clopidogrel after PCI as a function of their exposure to CYP3A4 inhibitors has not been fully resolved. Methods: Using the administrative databases from the Province of Québec, we identified all patients in 1999 and 2000 who received an outpatient prescription for clopidogrel within 5 days of PCI with stenting. Using multiple logistic regression, we compared the odds ratios (OR) of the composite cardiovascular outcome within 30 days of the index PCI between patients prescribed drugs inhibiting CYP3A4 activity and those who were not. Event rates were adjusted for demographic variables, disease severity, associated comorbidities, and other medications. Results: The 2927 patients who were prescribed clopidogrel after PCI were included in our cohort. Of these, 727 were prescribed atorvastatin and 2200 were not. There were 33 (4.54%) adverse events in the group prescribed atorvastatin and 68 (3.09%) in the group not prescribed atorvastatin. The adjusted 30-day OR of the composite outcome was 1.65 (95% CI 1.07-2.54) in patients prescribed atorvastatin with clopidogrel compared to those not prescribed atorvastatin. Other drugs that are substrates for CYP3A4 (OR 1.56, 95% CI 1.02-2.37) and a delay in filling the clopidogrel prescription (OR 1.77, 95% CI 1.16-2.70) were also associated with a higher risk. Sex, previous hospitalizations for unstable angina or myocardial infarction, aspirin use, or a history of revascularization (PCI or coronary artery bypass graft) in the 6 months before the index procedure was not statistically associated with adverse outcomes. Conclusions: After coronary stenting, a delay in filling the prescription for clopidogrel as well as prescriptions for drugs inhibiting CYP3A4 enzyme activity was associated with adverse cardiovascular events. However, because of the limitations of observational study designs, the clinical significance of these putative drug interactions remains uncertain but merits further investigation. IntroductionCoronary stenting is frequently performed after percutaneous coronary intervention (PCI) both to prevent the acute complications of balloon angioplasty and to decrease restenosis rates.[1] Unfortunately, these intracoronary metallic scaffolding devices are highly thrombogenic, especially in the first few days after insertion.[2,3] Thienopyridine antiplatelet agents, including clopidogrel, decrease the incidence of acute and subacute thrombotic complications after coronary stent implantation.[4-6] Clopidogrel is an inactive prodrug that is metabolized into its active form primarily by the cytochrome P450 3A4 (CYP3A4) enzyme system.[7-9] Recently, there has been concern that statins that are metabolized by CYP3A4 (atorvastatin, lovastatin, simvastatin, and cerivastatin) could potentially inhibit the conversion of clopidogrel to its active form, thereby negating its antiplatelet effect.[7,8,10] However, several other studies have not demonstrated an important clinical interaction between atorvastatin and clopidogrel, although these studies have had limited statistical power to exclude a small, but clinically meaningful, effect.[11-14] Therefore we retrospectively examined cardiovascular event rates within 30 days of PCI in a large cohort of patients who underwent coronary stenting and who were prescribed clopidogrel. We tested the hypothesis that patients prescribed competitive inhibitors of CYP3A4 activity, particularly atorvastatin, with clopidogrel after PCI would have a higher rate of the adverse cardiovascular events than those prescribed clopidogrel without these drugs. -------------------------------------------------------------------
September 26, 2006
INHALED CORTICOSTEROIDS REDUCE DEATH IN PATIENTS WITH COPD Cardiovascular Deaths Reduced by Over One Third
(NORTHBROOK, IL, September 11, 2006) — Patients with chronic obstructive pulmonary disease (COPD) who use inhaled corticosteroids may have a significantly decreased mortality risk, according to a new study published in the September issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP). New research shows that patients who received inhaled corticosteroids within 30 days of hospital discharge had a 25 percent reduced all-cause mortality rate. Cardiovascular-related death alone in patients using steroids paired with beta-agonists was reduced by 38 percent.
"COPD is an undertreated lung disease that has associated heart disease," said author Christine Macie, MD, FCCP, Cambridge Hospital, Ontario, Canada. "Controversy exists with respect to the effect of inhaled corticosteroids on mortality. Our study examined the effect of inhaled corticosteroids on survival, and results suggest that the survival is longer in patients using inhaled corticosteroids."
From April 1995 to March 2000, Dr. Macie and researchers from the University of Manitoba, Winnipeg, Canada, assessed the influence of inhaled corticosteroids on mortality in patients, 90 to 365 days posthospital discharge for COPD. Researchers collected patient information from a comprehensive database, excluding those who died within 90 days. In total, 4,987 patients were split into two groups: those between the ages of 35 to 64 (965) and those 65-years-old or older (4,002). Within those groups, patients who received inhaled corticosteroids within 90 days of hospital discharge were compared with those who did not.
Dr. Macie and colleagues found that the mortality rates in patients 65+ who received inhaled corticosteroids were 11.7 percent, compared with 13.1 percent for those who did not. Patients in the younger group showed even greater results, with a mortality rate of 3.0 percent for patients receiving inhaled corticosteroids within 90 days, compared with 6.0 percent for those who did not, providing a mortality reduction rate of 53 percent. When patients who received steroids in the year prior were removed from the analysis, mortality was reduced by 34 percent. Researchers attribute this finding to multifactorial reasons, including reductions in exacerbations of the disease and suppression of inflammation.
Researchers also found a 23 percent reduced risk of death when comparing the effects of inhaled steroids with bronchodilators in patients in the 65+ group. In all cases, the most significant results were found when inhaled corticosteroids were administered within the first 30 days following hospital discharge.
"Our results indicate that the effect of inhaled corticosteroids is relatively short-term and that those currently using it are relatively better protected, " said Dr. Macie. "Inhaled corticosteroids should be prescribed as soon as clinically indicated. By treating COPD with inhaled corticosteroids, we have the potential to reduce the effect and prolong life."
"The findings from this study are intriguing for clinicians and point to the need for further research to define the role and mechanisms of the effect of inhaled corticosteroids on both cardiovascular and respiratory mortality," said W. Michael Alberts, MD, FCCP, President of the ACCP.
CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at www.chestjournal.org. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP’s mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication.
Register now for CHEST 2006, the annual international scientific conference of the American College of Chest Physicians, held October 21-26, in Salt Lake City, UT. CHEST 2006 will feature more than 750 new scientific studies related to a variety of pulmonary topics, including asthma, COPD, lung cancer, cardiovascular disease, critical care, sleep medicine, and more. For media registration, visit the CHEST 2006 virtual pressroom at www.chestnet.org. For more information about the ACCP, please visit the ACCP Web site at www.chestnet.org. ----------------------------------------------------------------------------------------
September 20, 2006
Aging and Frailty are not necessarily linked, researchers say
Could the connection between old age and frailty become an idea of the past? Numerous scientists are predicting just that.
While it is a commonly held belief that muscle weakness, exhaustion and weight loss typical of frailty are the inevitable result of aging, research is not indicating they are preventable and possibly treatable conditions, according to a report in the Boston Globe.
Research indicates that exercise can prevent or reduce frailty, and new drugs on the market target particular symptoms of frailty, including muscle weakness. The newspaper reported that several major drug companies are testing medicines designed to stimulate growth hormones to see if they can promote increases in muscle mass and strength. --------------------------------------------------------------------
September 19, 2006
Memory Complaints Could Foreshadow Alzheimer's Disease
Although they scored fine on cognitive tests, olderadults with memory complaints still might have early onset Alzheimer's disease, according to a new study.
Researchers at Dartmouth Medical School in Hanover, NH, studied 120 adults age 60 to 90. Using MRI scans, the researchers determined that certain brain regions of participants who complained that they repeatedly had trouble with forgetfullness -- dispite having normal cognitive test scores -- looked similar to those with early dementia. Researchers noted that the other brain regions of the subjects with memory loss appeared to be no different from health subjects.
The results indicate that older adults who report significant problems with memory loss “warrant evaluation and close monitoring over time,“ according to researchers. The study appeared in the September issue of Neurology. ----------------------------------------------------------------
September 14, 2006
FDA Releases Alert Concerning Concomitant Use of Ibuprofen and Aspirin On September 8 the Food and Drug Administration (FDA) notified consumers and health care professionals that taking ibuprofen and aspirin at the same time may interfere with the benefits of aspirin taken for the heart. The alert states that ibuprofen can interfere with the anti-platelet effect of low dose aspirin (81 mg per day), which may render aspirin less effective when used for cardio protection and stroke prevention. Although it is acceptable to use ibuprofen and aspirin together, FDA recommends that consumers contact their health care professional for more information about how to take these two medicines so they are effective. Although I agree with the above and taking Ibuprofen in the geriatric population may lead to other serious problems with GI bleeding, ulcers and kidney problem when used for long periods of time, I disagree with the use of “low dose 81mg“ Aspirin for cardio protection and stroke. Too many studies show that it takes a full strength Aspirin (325mg) Enteric Coated Aspirin a day to be assured of the cardio protection and stroke prophylaxis. But if you have to take ibuprofen keep the two drug separated by at least 4 to 6 hours. Other analgesics that are not considered NSAID class are better choices for the geriatric to use. (OTC Acetaminophen or Rx Tramadol are advised) --------------------------------------------------------------------
September 13, 2006
More Bad News for Vioxx
In a meta-analysis of studies involving COX-2 inhibitors, researchers found that Merck & Co.'s Vioxx (rofecoxib) was associated with an increased risk of renal problems and heart arrhythmia. In a separate analysis of previously published COX-2 inhibitor data, researchers suggest that the data showed that Vioxx increases the risk of cardiovascular events during the first 30 days of treatment.
In the first meta-analysis, Harvard researchers examined results from 114 trials of COX-2 inhibitors, involving a total of 116 094 patients, in an effort to identify risks of kidney-related problems and arrhythmia. According to the researchers, the results suggested that patients taking Vioxx had an increased risk of experiencing renal problems and heart arrhythmia compared to control groups.
Furthermore, the researchers concluded that there was no "class effect" because other COX-2 inhibitors examined in the analysis were "not significantly associated" with an increased risk of these problems. "Vioxx seems to increase renal and arrhythmia (risks) more than any of the other drugs," noted researcher Eric Ding, as reported in Morningstar.
In a separate study, researchers at the University of Newcastle in Australia reviewed data from controlled observational studies to compare the risks of serious cardiovascular events in patients who received COX-2 inhibitors or other NSAIDs. The researchers indicated that their findings confirm those from randomised trials regarding the cardiovascular risks associated with Vioxx, including an increased risk within one month of starting treatment.
JAMA published both study results online ahead of its scheduled publication date, due to the "public health implications" of the findings. ----------------------------------------------------------------------
September 5, 2006
Two strokes, you’re out: Study looks at death risk and ethnic differences in stroke survivors who have a second stroke
Having a stroke is bad enough. But having another one after surviving the first one is especially bad, more than doubling a person’s risk of dying in the next two years, a new study finds.
The risk of a second stroke is especially high among members of the largest and fastest-growing subgroup of Latinos in the United States: Mexican-Americans. The new study finds that they are more likely than their non-Latino white neighbors to suffer another stroke in the first two years after living through one.
The study, published in the Annals of Neurology by a team from the University of Michigan Stroke Program in conjunction with colleagues in Texas, highlights the importance of what doctors call ‘secondary prevention.’
In other words, those who live through a stroke should get special attention from their physicians and other health professionals to reduce their risk of having another one. And, because of their extra risk of suffering another stroke, those efforts should be especially stepped up in Mexican-Americans, the researchers say.
“This finding completes a picture that has been taking shape through research on ethnic differences in stroke,” says lead author Lynda Lisabeth, Ph.D. “We know that Mexican-Americans have a higher overall risk of stroke, tend to have strokes starting at younger ages, and generally have a better chance of surviving their first stroke, compared with non-Hispanic whites. Now, by finding this higher rate of recurrence, we have a better idea of the overall burden of stroke in this population.”
Lisabeth, an assistant professor of epidemiology at the U-M School of Public Health, performed the study with her colleagues from the U-M Medical School, who have led a study of stroke in the southeastern coastal area of Texas near the city of Corpus Christi for several years. That area was chosen because of its large population of Mexican-Americans; they make up just over half the population.
Because of the predominance of Mexican-Americans and non-Latino whites in the study population, results for other Latino subgroups and African-Americans are not available.
The study followed 1,345 people who had their first strokes between 2000 and 2004 — 53 percent of whom were Mexican-Americans — and determined the frequency of recurrence through the end of 2004 and recorded details about their demographics, other health problems, and whether or not they had had another stroke.
They then compared these recurrent stroke patients with the other stroke survivors who had not had a second stroke; in all the study includes data from 124 recurrent stroke patients and 417 deaths among 1,311 stroke survivors for whom complete data were available.
Mexican-American ethnicity was a strong factor in a person’s risk of a second stroke. The risk of recurrent stroke at two years among the first-time stroke survivors was 11 percent.
When the researchers looked at the risk of dying from any cause during the study period, the impact of having a second stroke was dramatic. Stroke survivors who suffered a second stroke were 2.67 times more likely to die than stroke survivors who did not have a second stroke in the study period. The increased risk from recurrent stroke was present for both ethnic groups even after the researchers corrected for other health factors, age and gender.
Now, Lisabeth says, she hopes other researchers will attempt to confirm these findings in other Latino subgroups and in other samples of Mexican Americans. And, it will be important to find out what factors – including genetics, cultural and lifestyle differences, and underlying health problems – contribute to the ethnic differences.
In the meantime, she and her colleagues suggest that people of any background who have survived a stroke or “mini stroke” (also called a transient ischemic attack or TIA) should talk with their doctors often about what steps to take to reduce the risk of another stroke. Quitting smoking, keeping cholesterol and blood pressure levels down, controlling blood sugar for people with diabetes, and having a healthy diet and exercise routine can all help.
The authors also call for better awareness of stroke prevention methods and stroke symptoms among all at-risk individuals, to help prevent a first stroke or speed the recognition of a stroke when it occurs. Stroke symptoms include sudden onset of weakness or numbness on one side of the body, difficulty speaking or understanding, sudden clumsiness or unexplained falls and suddent loss of vision in one of both eyes.
In addition to Lisabeth, the new paper’s authors are Melinda Smith, MPH, Devin Brown, M.D., M.S., Lemuel Moye, M.D., Ph.D., Jan Risser, Ph.D., and Lewis Morgenstern, M.D., of the U-M Medical School and the University of Texas Health Science Center at Houston.
The U-M Stroke Program, directed by Morgenstern, is part of the U-M Cardiovascular Center; for more information, visit www.med.umich.edu/stroke.
August 29, 2006
Macular Degeneration Essential Information:
If you have Macular Degeneration or a family history of AMD then you should read this.
Macular Vitamin Supplements
REQUIRED DAILY AMOUNTS:
Lutein-18-20mg.
Zeaxanthin 6mg. (health food store, Solaray Brand)
Zinc
Copper
Beta Carotene at least 25,000U
Vit. E
Vit. C
(A practical way to take these are to
1. purchase the Lutein 20mg capsules, Zeaxanthin 6mg capsules and the Beta
Carotene 15mg capsules separately and also take a Centrum Silver tablet
which will supply the remainder of the needed vitamins.
BOSTON -- Research performed at Schepens Eye Research Institute and Department of Ophthalmology, Harvard Medical School has established that the dietary zeaxanthin (zee-uh-zan'-thin) plays an essential role in protecting the retina of the eye from the damaging effects of light.
From the many carotenoids in the diet, the human retina selectively accumulates only two: zeaxanthin and lutein. Their concentration is so high in the macula, (the retinal region responsible for fine visual activities) that the carotenoids are visible as a dark yellow spot called the macular pigment. Because these carotenoids absorb blue light, and because they are powerful antioxidants, scientists have hypothesized that they protect the retina. Working with quail as an animal model, the Schepens project provided the first direct experimental evidence that carotenoids do protect the retina.
Macular pigment has been implicated as a risk factor in age-related macular degeneration (AMD), the most prevalent cause of vision loss in the elderly. Vision loss in AMD is due to the irreversible death of photoreceptors and/or the invasion of leaky, unwanted blood vessels into the retina. At advanced stages of this progressive disease, everyday activities such as reading, driving, or even seeing the face of a loved one become impossible.
It is estimated that more than 17 million Americans may have symptoms of AMD and that 2 million have functional blindness; 500,000 new cases are diagnosed each year. Some clinical studies have found evidence that people with higher dietary or serum levels of zeaxanthin and lutein had reduced risk for advanced stages of age-related macular degeneration, but others have found no association.
Significantly lower macular pigment levels have been found in people with factors known to increase risk for AMD (e.g. smoking), in eyes with AMD, and in eyes at high risk for AMD. Epidemiologic studies have shown that people with higher dietary or plasma lutein/zeaxanthin have reduced risk for advanced stages of AMD. It is not yet clear whether the reduced risk for AMD is due to lutein/zeaxanthin or due to some other nutrient in the plants containing carotenoids. The Schepens work has clearly shown that the carotenoids protect the retina from light damage in animals. Some studies, but not all, have identified light damage as a risk factor in AMD. To test this hypothesized protection, the team selected Japanese quail, because the retina resembles the human macula in having more cone photoreceptors than rods, and in highly selective accumulation of zeaxanthin and lutein from their diet. Rodents were not studied because their retinas have very few cones and do not accumulate carotenoids. The studies examined the effect of manipulating dietary carotenoids on light damage to retinas. C. Kathleen Dorey, principal investigator formerly with Schepens and now with R&D Consulting, and her colleagues raised quail on diets that were normal, carotenoid-deficient, or carotenoid-deficient supplemented with high doses of zeaxanthin.
In the short-term study, reported in the November 2002 issue of Investigative Ophthalmology and Visual Science (IOVS), the team divided the carotenoid-deficient quail into two groups, and for one week preceding light damage, they fed one group zeaxanthin-supplemented diet. The study established that photoprotection was strongly correlated with the concentration of zeaxanthin in the retinas of the quail. Retinas with low concentrations of zeaxanthin had suffered severe light damage, as evidenced by a very high number of apoptotic photoreceptor cells, while the group with high zeaxanthin concentrations had minimal damage. Apoptosis is programmed cell death, the final common pathway for photoreceptor death in retinal degeneration.
In the long-term study, reported in the November 2002 issue of Experimental Eye Research, groups of quail were raised for six months on carotenoid-deficient, normal or zeaxanthin-supplemented diets before exposure to brighter light. The results showed extensive damage to the retina in the carotenoid-deficient animals, as evidenced by large numbers of both dying photoreceptors and gaps or "ghosts" marking sites where photoreceptors had died. The group of quail with normal dietary levels of zeaxanthin showed significantly less retinal damage than did the zeaxanthin-deprived group, while the quail group receiving high levels of zeaxanthin had few ghosts in their retinas.
These experiments by Dr. Dorey's team showed protection of both rod and cone photoreceptors. The research further demonstrated that retinas were protected by both zeaxanthin and another antioxidant, vitamin E. Damage in these experiments was clearly reduced by zeaxanthin and tocopherol, but not lutein. Further experiments would be needed to determine whether elevated lutein would offer protection.
These results are reminiscent of the early 20th century discovery of the role of vitamins. In those experiments, extensive efforts were made to show that dietary deficiency of a compound caused health problems that were reversed by adding the substance back to the animal's diet.
The results of the Schepens studies come on the heels of the Age Related Eye Disease Study (AREDS), sponsored by the National Eye Institute of the National Institutes of Health, which concluded that daily consumption of a formula containing high doses of dietary antioxidants are effective in slowing the progression of AMD in patients with advanced stages of the disease. It is noteworthy that zeaxanthin and lutein, two antioxidants selectively concentrated by the macula, were not commercially available when the AREDS began and were, therefore, not able to be included in that study. Commenting on the implications of the Schepens studies, Dr. Dorey said: "AMD is a multi-factorial disease clearly influenced by both genetic (family history) and environmental factors (diet, and possibly light history). The retina is constantly exposed to oxidative injury, a leading candidate for initiating or accelerating retinal degeneration. Zeaxanthin is well suited to its role in maintaining retinal health, and may be an important strategy to prevent or intervene in macular degeneration. It accumulates in the macula where it absorbs harmful blue wavelength light, and it accumulates in the RPE and the most vulnerable portions of the photoreceptors where its potent anti-oxidant capacity can prevent oxidative damage, a problem that increases with aging.
"Our studies showed that light damage was strongly influenced by the amount of zeaxanthin in the retina, and that significantly greater retinal protection was provided at dietary levels higher than those normally occurring in the diet. Zeaxanthin has been extensively studied for safety and has been reviewed as a dietary ingredient by the FDA. We hope this work further stimulates interest in clinical trials, and believe that zeaxanthin has a potential to eventually complement other strategies to improve the treatment of this vision-robbing disease."
The research team included:
** Lauren R. Thomson, M.D. Yoko Toyoda, M.D. Z-Y Wong, M.D., Francois C. Delori, Ph.D., and C. Kathleen Dorey, Ph.D. (now with R&D Consulting) at Schepens Eye Research Institute.
** Kevin M. Garnett, BS, MBA at Applied Food Biotechnology, Inc. (O'Fallon, Mo. )
** Kimberly M. Cheng, Ph.D. and Cathleen R. Nichols at Department of Animal Sciences, University of British Columbia ( Vancouver )
** Neal E. Craft, Craft Technologies, Inc. ( Wilson , N.C. )
UPDATE: Press release
A recent human study from the Medical Research Council Environmental Epidemiology Unit, University of Southampton , U.K. provides scientific evidence that a key nutrient and a strong antioxidant member of the carotenoid family, called zeaxanthin (zee-ah-ZAN'-thin,) may be far more important in preventing or stabilizing macular degeneration than previously realized. Macular pigment, which is primarily composed of lutein and zeaxanthin, is thought to protect the retina from damage due to light exposure and oxidative stress. Additionally, it has been shown that a high macular pigment density helps to retain visual sensitivity as we age and evidence indicates that raising the intake of dietary zeaxanthin can increase macular pigment. The macular pigment acts like "sunglasses" by protecting the critically important central sight from damaging light waves. The distribution of lutein and zeaxanthin in the eye may indicate they have different functions. Zeaxanthin is the dominant component in the center of the macula, while lutein dominates at the outer edges. The eye is selective and preferentially places dietary zeaxanthin in the very center of the macula, the most critical area for central vision with the greatest need for protection. This selective uptake of zeaxanthin occurs even though lutein is more available in the diet by a 20:1 ratio. Previous investigations may have obscured evidence of zeaxanthin's greater protective role by looking at the two carotenoids together, rather than separately. Although both of these carotenoids protect the retina, zeaxanthin has been shown to be a better photoprotector and a recent animal study supports the photoprotective activity of zeaxanthin. Additionally, zeaxanthin's chemical structure makes it a much more effective antioxidant than lutein. The human study concluded that decreased blood plasma zeaxanthin, but not blood plasma lutein, is significantly associated with the risk of age-related macular degeneration. This correlation strongly indicates that a high level of dietary zeaxanthin intake may directly affect the risk of developing macular degeneration. Increasing intake through diet or supplementation may help to slow down or stop vision loss with those who have been diagnosed with AMD.
The research team included Catharine R. Gale, Nigel F. Hall, David I.W. Phillips and Christopher N. Martyn.
What foods are highest in zeaxanthin content?
ZEAXANTHIN CONCENTRATION IN FRUITS & VEGETABLES
|
NDB
|
FOOD
|
ZEAXANTHIN
|
SERVING
|
11172
|
Corn, drained
sweet, yellow, canned, whole kernel
|
528 mcg
|
432.96 mcg
|
1/2 cup
|
11457
|
Spinach, raw
|
331 mcg
|
185.36 mcg
|
1 cup
|
11162
|
Collards, drained
cooked, boiled, without salt |
266 mcg
|
170.24 mcg
|
1/2 cup
|
11458
|
Spinach, drained
cooked, boiled, without salt |
179 mcg
|
161.1 mcg
|
1/2 cup
|
09215
|
Orange juice, frozen concentrate
unsweetened, diluted
|
80 mcg
|
149.12 mcg
|
3/4 cup
|
11251
|
Lettuce, raw
cos or romaine
|
187 mcg
|
104.72 mcg
|
1 cup
|
09200
|
Oranges, raw
all commercial varieties
|
74 mcg
|
96.94 mcg
|
1 medium
|
09218
|
Tangerines, raw
(mandarin oranges)
|
112 mcg
|
94.08 mcg
|
1 medium
|
11308
|
Peas, drained
green, canned, regular pack
|
58 mcg
|
49.3 mcg
|
1/2 cup
|
11252
|
Lettuce, raw
iceberg, includes crisp head types
|
70 mcg
|
39.2 mcg
|
1 cup
|
11056
|
Beans, drained
snap, green, canned, regular pack
|
44 mcg
|
29.92 mcg
|
1/2 cup
|
11091
|
Broccoli, drained
cooked, boiled, without salt
|
23 mcg
|
17.94 mcg
|
1/2 cup
|
11144
|
Celery, drained
cooked, boiled, without salt |
8 mcg
|
6 mcg
|
1/2 cup
|
09236
|
Peaches, raw
|
6 mcg
|
5.22 mcg
|
1 medium
|
11960
|
Carrots, baby, raw
|
23 mcg
|
2.3 mcg
|
1 medium
|
11143
|
Celery, raw
|
3 mcg
|
1.8 mcg
|
1/2 cup
|
NDB = Nutritional Data Base
mcg = micrograms; 1000 micrograms = 1 milligram |
For a printable chart, click here.
The USDA-NCC Carotenoid Database was created through a collaborative effort between the USDA and the Nutrition Coordinating Center (NCC) at the University of Minnesota. The AMDF has calculated the amount of zeaxanthin per serving based on the amount of zeaxanthin per 100 grams as provided by the USDA-NCC database. The USDA-NCC database also calculated 457 micrograms of zeaxanthin in 100 grams of enriched yellow cornmeal, 173 micrograms of zeaxanthin in 100 grams of cooked kale and 267 micrograms of zeaxanthin in 100 grams of cooked turnip greens. The British Journal of Opththalmology [The British Journal of Ophthalmology (Aug. 1998, 82: 907-910)] reports the highest mole percentage (% of total) of zeaxanthin is orange peppers at 37% mole weight and egg yolk at 35% mole weight.
We believe this limited information available today can nevertheless serve as a guide for our readers to increase the quantity of zeaxanthin in their diet. There is no known optimal amount of zeaxanthin at this time. However, research indicates the nutrients in these foods may increase the concentration of macular pigment, thus building more healthy eyes. D. Max Snodderly, Ph.D., head of the laboratory at The Schepens Eye Research Institute, said, “It appears that people lose visual sensitivity before the worst stages of disease. But with the right nutritional program, you might prevent the low macular pigment group from getting worse, and in the best cases even recover some of the lost function.” Dr. Snodderly, with co-authors Billy Hammond and Billy R. Wooten, reported their findings in Investigative Ophthalmogy & Visual Science.
Since no daily recommended allowance of zeaxanthin currently exists, JoAnn Prophet, a registered dietitian with the American Institute for Cancer Research in Washington, D.C., advises people to follow the usual dietary recommendations. These recommendations suggest eating at least five servings of a variety of fruits and vegetables daily and to add extra grains and beans to daily meals. This should enable people to reap the benefits of the hundreds, perhaps thousands, of phytochemicals that can help prevent disease and promote good general health.
Phytochemicals are naturally occurring compounds found in plants - fruits, vegetables and grains. Experts think that phtyochemicals may play a major role in slowing the aging process.
Phytochemicals were discovered only within the last ten years and researchers are still trying to assemble the needed data on their potential. Ms. Prophet advises that information on the 500 newly-discovered phytochemicals currently being examined by scientists will probably surface in news reports on a regular basis as individual fruits and vegetables are associated with specific phytochemicals. [“The promise of phytochemicals” by JoAnn Prophet, R.D., MSNBC.com on June 26, 2000.]
Study Demonstrates Essential Role of Zeaxanthin in Eye Health
Study Links Zeaxanthin to Macular Health
George Torrey, Ph.D., a graduate of Brown (‘61), Harvard (‘62) and the Univ. of Connecticut (‘68), writes for the AMDF Newsletter and the AMDF Web site. Both his parents suffered from macular degeneration.
July 31, 2006
Researchers: Eye is New Window for Alzheimer’s Detection
A new, non-invasive, laser technology may help detect Alzheimer’s Disease at its earliest stages, according to researchers.
Researchers at Brigham & Women’s Hospital and Harvard Medical School developed a technique to detect plaques in the eye of laboratory mice. People with Alzheimer’s have beta-amyloid deposits, or plaques, that appear as usual cataracts in the lens of the eye.
“This makes the (eye) lens an ideal window for early detection and disease monitoring in Alzheimer’s,” said researcher Lee E. Goldstein. --------------------------------------------------------------------
July 25, 2006
1st Signs of Dementia May Be Physical
May 22, 2006 – The first signs of Alzheimer’s disease and other forms of dementia among older people may be physical rather than mental, new research suggests.
The findings are a strong indicator that physical and mental performance among the elderly are interconnected, researcher Eric B. Larson, MD, tells WebMD.
“If we expect the earliest sign of dementia to be subtle changes in cognition, we are probably going to be wrong,” he says.
Mind-Body Connection
The study by Larson and colleagues at the University of Washington and the VA Puget Sound Health Care System included 2,288 older people followed for six years.
All the participants were members of a Seattle-based managed care cooperative, and all were aged 65 or older at study entry. None was diagnosed with dementia or Alzheimer’s disease at enrollment in the trial, based on standardized cognitive testing, which was repeated every two years.
Physical function testing was also conducted -- evaluating for walking, standing balance, hand grip, and the time needed to stand from being seated in a chair repeated five times.
At the beginning of the study, people with lower baseline physical-performance scores also had lower baseline cognitive test scores. During the six years of follow-up, 319 study participants developed dementia, with 221 of these having a diagnosis of Alzheimer’s disease.
Each 1-point decline in physical-performance score was associated with an increased risk for developing dementia -- with 16 points representing the best physical function and 0 representing the worst. People who scored higher than 10 were far less likely to develop dementia than those with scores of 10 or lower.
Gait slowing and poor balance were more common in people later diagnosed with Alzheimer’s or some other dementia. Poor handgrip seemed to be associated with later dementia in people who already showed early signs of mild cognitive decline.
Can Exercise Delay Alzheimer’s?
The new study, supported by a grant from the National Institute on Aging, is published in the May 22 issue of the Archives of Internal Medicine. In another study published earlier this year, Larson and colleagues concluded that regular exercise may reduce the risk of Alzheimer’s among older adults.
Older people in the earlier study who reported exercising three times a week or more developed Alzheimer’s a third less often during the six-year-old study than people who exercised less.
Larson says an older person who does not exercise and is declining physically should be encouraged to become more physically active.
“Many people just sit down and accept the inevitable, and if you accept the inevitable you will get it,” he says.
Dallas Anderson, PhD, of the National Institute on Aging, agrees that regular exercise is important for the elderly for a host of reasons. But he adds that it is not yet clear if delaying the onset of Alzheimer’s is one of them.
Anderson is program director for studies into the epidemiology of dementia with the Dementias of Aging branch of the NIA.
It has been suggested that regular exercise protects against mental decline by improving blood flow to the brain.
That may be true, Anderson tells WebMD. But it may also be true that older people tend to become less physically active with advancing mental decline. So instead of regular exercise being protective against dementia, it may just be a sign that mental function has not been impaired.
“In a sense the dementia process could be causing people to exercise less,” Anderson says.
He also points out that older people who exercise regularly may have other habits that could help reduce their Alzheimer’s risk.
“They are probably more disciplined,” he says. “They may eat a better diet or be more socially engaged. They may be doing any number of things that seem to be positive.”
SOURCES: Wang, L. Archives of Internal Medicine, May 22, 2006; vol. 166: pp 1115-1120. Eric B. Larson, MD, MPH, director, Center for Health Studies, University of Washington, Seattle. Dallas Anderson, PhD, program director for studies in the epidemiology of dementia, Dementias of Aging Branch, National Institute on Aging, National Institutes of Health, Bethesda, Md. WebMD Medical News: "Regular Exercise May Delay Alzheimer's."
----------------------------------------------------------------------
July 21, 2006
Ranibizumab Approved for Use in Patients with Age-Related Macular Degeneration The Food and Drug Administration (FDA) has approved the use of ranibizumab (Lucentis) injection in patients suffering from neovascular (wet) age-related macular degeneration (AMD). This is the first treatment ever made available in patients presenting with wet AMD. It blocks the formation of new/leaky blood vessels that ultimately injure the eye. Wet AMD accounts for 10% of all AMD cases, but for 80% of associated vision loss. This will be the first FDA-approved medication to provide prescription information in the new format for prescription drug package inserts. For more information, visit http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html -----------------------------------------------------------------------
July 14, 2006
Evista Might Increase Risk of Stroke Death, Study Finds
Eli Lilly & Co.'s Evista drug may increase the risk of blood clots and fatal stroke in older women, a finding that may discourage its use to prevent bone- thinning osteoporosis in some patients.
Women who took Evista had a 49 percent increase in their risk of dying from stroke compared with those taking a placebo, a study found. Their chance of getting blood clots from use of the drug, known chemically as raloxifene, rose by 44 percent in the research involving 10,101 women in 26 countries.
Patients will have to balance those risks against the protection Evista offers against osteoporosis and breast cancer, said Lori Mosca, director of preventive cardiology at New York Presbyterian Hospital. Women in the study who took Evista were 44 percent less likely to develop breast cancer, a finding that mirrored previous studies.
``Usefulness of this drug in any woman will depend on her personal risk of breast cancer, osteoporosis, stroke and blood clots,'' said Mosca, who co-wrote the study, in a telephone interview today. ``It's not a one-size-fits-all answer.''
The study will be published tomorrow in the New England Journal of Medicine.
Evista was approved in 1997 to prevent osteoporosis, which can lead to fractures. Researchers suspected that it might also have an effect on breast cancer and heart disease, like other drugs that modify the effects of the female hormone estrogen such as tamoxifen.
The most recent study, led by Elizabeth Barrett-Connor of the University of California, San Diego, followed post- menopausal women who had existing heart disease, or risked developing it because of smoking or conditions such as diabetes.
Deaths
After about 5 1/2 years, there was no difference in rates of heart attacks or heart-related hospitalizations and deaths among Evista users and those who received a placebo. While strokes in the treated and untreated group were in the same range, 59 women who took Evista died of the brain illness, compared with 39 women who got a placebo.
Lilly released partial findings from the study April 12, at the request of the U.S. Food and Drug Administration. Lilly said then that while overall stroke rates in the study were low, Evista was associated with ``an increase in stroke mortality.''
Data from the study, including the precise increase in risk of stroke death, were not released because the findings had not yet been reviewed by experts, said Keri McGrath, a Lilly spokeswoman, in a telephone interview today.
Reviewing the Label
Lilly recommended then that doctors consider women's stroke risk when prescribing Evista, and the company is reviewing the drug's label with the FDA, she said.
The label doesn't mention risk of death from stroke. The company has communicated Evista's risks with doctors, pharmacists, other health professionals and patients through its sales force and direct mail, McGrath said.
The breast cancer finding in the most recent study supported the result of a different study, released in June, which said Evista is as effective against breast cancer as tamoxifen, the standard treatment for that disease.
Lilly has said it is planning to apply to the FDA for approval to market the drug as a breast cancer preventative.
Older women with a family history of stroke or high blood pressure should consider using Evista alternatives for osteoporosis, such as supplemental Calcium (Calcium Citrate, Citracal + Multivitamin), when treating patients at elevated stroke risk, the researchers said.
_______________________________________
July 8, 2006
Brief intervention reduces symptoms of depression
Taking a page from the treatment book on alcohol abuse, researchers from the University of Washington have successfully tested a brief, low-cost intervention to deal with depression, the No. 1 mental health problem in the United States.
Students with mild depression who received the intervention through the mail reported a 20 percent reduction in the severity of their symptoms one month later, compared with an 8 percent drop for another group that was not treated. In addition, feelings of hopelessness among the students who received the brief intervention dropped 31 percent, while those emotions only fell 7 percent for the other students.
Brief interventions have been utilized effectively in alcohol treatment for a number of years, and the concept transferred to depression, said Irene Markman Geisner, lead author of a study appearing in the current issue of the Journal of Consulting and Clinical Psychology and a psychology doctoral student at the University of Washington.
"There is a tendency to think that college students are a privileged group with no real problems. But depression is a serious concern among college students," said Mary Larimer, a study co-author and UW associate professor of psychiatry and behavior sciences. "Our counseling centers are overrun with depression, as well as other problems."
"At any given time, up to 35 percent of college students have depressed moods," said Geisner. "They are not clinically depressed, per se, but their mood clouds their academic and social lives and puts them at much greater risk for future clinical depression."
For the study, nearly 1,200 students were screened for symptoms of depression. More than 200 met the criteria for depression, and 177 were recruited and completed a more-detailed baseline assessment for depression and how they cope with it.
A week after this assessment, half of the students received the intervention that consisted of a personalized feedback letter and a brochure. The letter began with a paragraph that told the students the concerns they reported during the assessment were consistent with depression and that this is a common experience for college students. The letter then reflected the personal concerns students expressed. It also listed the various coping strategies each was already using to deal with his or her depression, and indicated that there were many things the students could do to reduce depression.
The brochure, prepared for the study, listed six types of strategies students could use -- social support, pleasant activities, exercise, self-help literature, meditation and spirituality, and medication -- to help relieve their depression. The brochure also gave the students examples of problem solving and how to change their thought processes. Finally, it provided a list of on- and off-campus treatment resources.
The other group of students received thank-you letters for participating in the study. These letters listed common depression symptoms and provided a list of on- and off-campus telephone numbers students could call for help.
One month later, both groups were reevaluated to look at the impact of the feedback.
Geisner and Larimer said the idea of brief intervention treatment for depression needs more refinement and study but is promising, particularly because of its low cost. They estimate it cost less than $2 per person to deliver the treatment in this study. Other low-cost strategies that could be tested include weekly boosters delivered by e-mail and an Internet version of the treatment.
"The beauty of this study is that these people were not seeking help when they were sitting in a classroom, but help was brought to them," said Larimer. "People who received this brief intervention felt less hopeless and depressed, both physically and emotionally. Depression is a very costly problem and we should not wait for people to develop a more serious form of it before treatment is available."
Clayton Neighbors, a UW assistant professor of psychiatry and behavior sciences, was a co-author of the study funded by the National Institute on Alcohol Abuse and Alcoholism and the Stanley Foundation.
For more information, contact Geisner at (206) 419-8999 or geisner@u.washington.edu or Larimer at (206) 543-3513 or larimer@u.washington.edu
______________________________________
July 6, 2006
High Tylenol Doses Linked to Liver Woes
CHICAGO - Healthy adults taking maximum doses of Tylenol for two weeks had abnormal liver test results in a small study, researchers found, raising concerns that even recommended amounts of the popular painkiller might lead to liver damage.
In the study, 106 participants took four grams of Tylenol - equivalent to eight extra-strength Tylenol tablets - each day for two weeks. Some took Tylenol alone and some took it with an opioid painkiller. Dummy pills were given to 39 others.
There were no alarming liver test results among the people who took the placebos. But nearly 40 percent of people in all the other groups had abnormal test results that would signal liver damage, according to the study that appears in Wednesday's Journal of the American Medical Association.
"I would urge the public not to exceed four grams a day. This is a drug that has a rather narrow safety window," said a study co-author, Dr. Neil Kaplowitz of the University of Southern California.
Heavy drinkers should take no more than two grams daily, Kaplowitz said.
Another co-author, Dr. Paul Watkins of the University of North Carolina, said he's less worried than Kaplowitz, noting that acetaminophen, the active ingredient in Tylenol, has been used for 50 years and has a good safety record.
The maker of Tylenol, McNeil Consumer & Specialty Pharmaceuticals, said its own research found much lower rates of abnormal liver results. The company's studies tracked high-dose users over longer periods than did the new study.
"It doesn't lead to liver disease and it usually resolves as patients continue to take acetaminophen," said Dr. Edwin Kuffner, senior director of medical affairs at McNeil.
The researchers had been hired by the drug company Purdue Pharma LP, maker of the prescription painkiller OxyContin, to find out why abnormal liver tests were showing up in people testing a combination drug containing the acetaminophen and the opiate hydrocodone.
Purdue Pharma stopped its hydrocodone study early because of the abnormal liver tests. Researchers Watkins and Kaplowitz thought they would find the culprit in hydrocodone's interaction with acetaminophen.
"Our jaws dropped when we got the data," Watkins said. "It doesn't have anything to do with the opiate. It's good ol', garden-variety acetaminophen."
Acetaminophen is more popular than aspirin or ibuprofen. Each week, one in five U.S. adults uses it for pain or fever, a 2002 survey found.
Acetaminophen is included in numerous over-the-counter and prescription medications, making overdose possible as people unwittingly combine drugs. Overdoses of acetaminophen are the leading cause of acute liver failure.
"A week doesn't go by when I don't have to talk to someone about how much they're taking," said Kathleen Besinque of the USC School of Pharmacy.
Watkins said people considering switching painkillers should know that others have their own side effects, such as internal bleeding and stomach irritation.
New research under way at the University of North Carolina may determine if acetaminophen's effect on the liver continues for long-term, high-dose users, or if the body adapts, Watkins said.
JAMA: http://jama.ama-assn.org ____________________________________
July 4, 2006
Relation between age and cardiovascular disease in men and women with diabetes compared with non-diabetic people
Adults with diabetes are thought to have a high risk of cardiovascular disease (CVD), irrespective of their age. The main aim of this study was to find out the age at which people with diabetes develop a high risk of CVD, as defined by: an event rate equivalent to a 10-year risk of 20% or more; or an event rate equivalent to that associated with previous myocardial infarction.
The transition to a high-risk category occurred at a younger age for men and women with diabetes than for those without diabetes (mean difference 14·6 years). For the outcome of acute myocardial infarction (AMI), stroke, or death from any cause, diabetic men and women entered the high-risk category at ages 47·9 and 54·3 years respectively. When we used a broader definition of CVD that also included coronary or carotid revascularisation, the ages were 41·3 and 47·7 years for men and women with diabetes respectively.
Diabetes confers an equivalent risk to ageing 15 years. However, in general, younger people with diabetes (age 40 or younger) do not seem to be at high risk of CVD. Age should be taken into account in targeting of risk reduction in people with diabetes.
The Lancet 2006; 368:29-36 ____________________________________
June 24, 2006
COPD Patients not receiving recommended tests
At least two thirds of patients with chronic obstructive pulmonary disease (COPD) do not receive lung function testing that is recommended for the accurate diagnosis and effective management of the disease, suggesting that the majority of patients are diagnosed with COPD based on symptoms alone.
New research published in the June issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), finds that only one third of patients recently diagnosed with COPD underwent spirometry, a noninvasive lung function test, to confirm COPD or to manage their condition. Current national guidelines recommend spirometry for the diagnosis and management of COPD.
Researchers examined the use of spirometry among 197,878 patients (98 percent men) from the Veterans Health Administration (VHA) healthcare system who were newly diagnosed with COPD. Patient records were reviewed for the general use of spirometry and spirometry related to exacerbation or surgery over a 12-month period.
- Of the patients, 33.7 percent had at least one spirometry through the VHA over the course of a year.
- A random sample of 6,000 patients revealed an additional 4.3 percent of patients underwent spirometry in non-VHA settings.
- Among patients who experienced acute exacerbation of COPD, spirometry was performed only 21.4 percent of the time, despite current guidelines that recommend spirometry four to six weeks after an exacerbation.
- Spirometry was used most frequently around surgical procedures that required general anesthesia, with 85.5 percent of patients having spirometry performed 30 days or less before their procedure.
"COPD is a highly preventable disease most commonly caused by long-term smoking," said W. Michael Alberts, MD, FCCP, President of the American College of Chest Physicians. "Symptoms of COPD may not be noticeable for several years, making it difficult to diagnose and treat the disease in its early stages. Lung function testing for smokers and other high-risk patients may help with early identification of COPD and more effective disease management.”
Source: American College of Chest Physicians, June 12, 2006 http://www.chestnet.org/about/press/releases/2006/061206-2.php --------------------------------------------------------------
June 23, 2006
Panic disorder difficult to diagnose but very treatable
Panic disorder is fairly common, and can cause frightening symptoms that resemble those of heart, respiratory and gastrointestinal problems, according to a review by a University of Washington psychiatrist in the June 1 issue of the New England Journal of Medicine. But even though it can be difficult to diagnose, panic disorder is very treatable and most patients can be cured within just four to eight weeks.
The review of recent clinical research on panic disorder was conducted by Dr. Wayne Katon, professor and vice-chair of psychiatry at the UW School of Medicine. His analysis covers the epidemiology of panic disorder, as well as ways to screen for the condition and more effectively treat people suffering from it.
Katon found that between 3 percent and 8 percent of patients visiting their primary-care physicians had panic disorder. Most people suffering from the condition have had major stress-inducing factors in their lives within the year before their diagnosis, and people whose close relatives have had the disorder are at much higher risk.
Panic disorder can cause symptoms such as chest and abdominal pain, a pounding heart or irregular heartbeat, and shortness of breath. These alarming symptoms can often lead patients to be screened for serious physical ailments, like heart attack.
"They typically go through many medical tests before their physicians accurately diagnose them," said Katon, who studies the prevalence of mental health disorders. "Panic disorder is definitely diagnosable, and treatable -- people can usually be cured in four to eight weeks with either antidepressant medication or behavioral therapy, or a combination of the two."
Incorporating mental health professionals into primary-care settings can lead to physicians more quickly identifying and effectively treating patients with panic disorder, even when those patients may be exhibiting frightening symptoms. That faster diagnosis can help the patient, Katon explained, and can cut down on costs from unnecessary medical tests.
"Even though it costs money and resources to staff primary-care offices with mental health professionals, more effective treatment has been shown to decrease costs in the long run by decreasing health utilization and unnecessary medical testing of these patients," said Katon. --------------------------------------------------------------------
June 22, 2006
Blood Pressure in the Frail Elderly: Is Higher Better?
A prospective trial reported in the June 2006 issue of Journal of the American Geriatrics Society has confirmed observations from previous trials of hypertension: individuals older than the age of 85 have lower mortality when systolic blood pressure is higher. Study participants were followed for nine years to determine outcomes. The authors conclude that "results from clinical trials including younger participants should be applied cautiously and individually in the very old" and "the use of BP-lowering medications needs to be evaluated in this group."
An abstract of the study is at: http://www.blackwell-synergy.com/doi/abs/10.1111/j.1532-5415.2006.00742.x -----------------------------------------------------------------
June 21, 2006
Study: Heart attack victims shouldn’t take NSAIDs
The risk of dying from or having another heart attack is high among people who have survived a first heart attack and are taking non-steroidal anti-inflammatory drugs (NSAIDs), new research in the journal Circulation says.
In fact, researchers at Gentofte University Hospital in Copenhagen, Denmark, note that even short-term treatment with the painkillers, including COX-2 drugs, puts heart attack patients at significant risk.
The research adds to the mounting evidence suggesting COX-2 drugs — specifically, and possibly all additional NSAIDs, including ibuprofen and naproxen — can have a detrimental effect on heart attack patients, experts said. ------------------------------------------------------------------
June 20, 2006
Shorter pneumonia treatment just as effective, study says
Shortening antibiotic treatment of pneumonia to three days instead of the usual seven to 10 can be just as effective, according to new research.
In addition, the shorter course of treatment might help reduce general antibiotic consumption and antibiotic resistant respiratory infections, according to researchers at the Academic Medical Center in Amsterdam.
Researchers divided pneumonia patients into two groups. One was given intravenous amoxicillin for three days followed by placebo and the other group received eight days of antibiotic treatment. After 10 days, both groups had a clinical success rate of 93%. Nearly a month later, the placebo group’s success rate was 88%, versus a 90% success rate for the group with the longer course of treatment.
Although the accepted practice is to prescribe antibiotic therapy for several days after symptoms have improved, researchers contend that more studies are needed to show the benefits of shorter antibiotic therapies for infections.
The study report appears in the June 10 issue of the British Medical Journal. ------------------------------------------------------------------
June 19, 2006
Asthma drug increases risk of cataracts in elderly
Anti-asthmatic medications used to treat asthma or lung disease in the elderly may increase the risk of developing cataracts, according to a new study.
Canadian researchers studied more than 100,000 elderly people with either asthma or chronic obstructive pulmonary disease for more than 14 years. Those who took inhaled corticosteroids for asthma raised their risk of developing cataracts by 24% compared to patients who did not use the drugs, according to study author Dr. Samy Suissa, an epidemiologist at McGill University Health Center in Montreal.
The elderly should continue to take these medications but should try to reduce the dose of inhaled corticosteroids as much as possible, researchers said. The study was published in the European Respiratory Journal. -----------------------------------------------------------
June 7, 2006
Survey points to the emergence of the “healthcare consumers” in Canada
Majority of Canadian employees report taking control of decisions that affect their personal healthcare
Canadian health benefit plan members are becoming more active and empowered in the decisions that affect their own personal healthcare, a significant shift from the once passive attitude of “doctor knows best,” according to a new survey released today. The survey results indicate that these Canadians are seeking information, requesting second opinions and gathering information from sources other than their doctor – a trend identified as the emergence of the healthcare consumers.
Sanofi-aventis Canada Inc. commissioned Ipsos-Reid to conduct the 2006 survey, the ninth in the series, in January. Ipsos-Reid polled 1,500 employee health benefit holders from across Canada, seeking to understand their changing views about the role of the public system and employer-sponsored health benefit plans in maintaining health services and products. The research also explored the willingness and preparedness of plan members for a greater role in their own health decision-making and their willingness to take on a greater portion of the financial burden for health costs.
The survey outlined three predominant themes: 1) Benefit plan members are attempting to make more informed decisions regarding their healthcare, prioritizing health-related educational and support services from their employers. 2) The survey results clearly show that plan members place a high value on their benefit plans. 3) There is an increasing focus on the important role organizations play in creating healthy workplaces.
The emergence of the healthcare consumers
The trend of personal responsibility, first investigated in last year’s survey has been further investigated this year. Canadian plan members have accepted a certain level of responsibility and the majority report being active in decisions that affect their healthcare. For example, six in 10 (61%) say that when it comes to their healthcare, they look up their own information, question their doctor, and seek second opinions according to what they’ve learned. In contrast, the remaining 39% of respondents continue to believe that when it comes to their own healthcare, their doctor knows best and they seldom, if ever, question a diagnosis or recommendation.
“It’s the tip of the health consumerism iceberg! People are starting to take ownership, at least at an information level,” says Anthony May, a member of The sanofi-aventis Healthcare Survey Advisory Board who works for Manulife Financial in Vancouver. “It’s the first real evidence that we have seen that demonstrates this shift in personal responsibility when it comes to health outcomes.”
While the survey demonstrates that 63% of health benefit plan members are “very” or “somewhat frequently” obtaining health information from healthcare professionals, the Internet and other sources of information are quickly becoming alternative healthcare resources for Canadians. Specifically, four in 10 (43%) of respondents regularly access the Internet for information to help them in their healthcare decisions, three in 10 (29%) rely on media and 16% routinely receive health information from their employers.
Employee plans highly valued
Respondents have a positive opinion when it comes to the value placed on employee health benefit plans. According to the findings in this year’s survey, Canadian employers have a lot to celebrate. Specifically, there is a noticeable improvement in how well employer-sponsored benefit plans are perceived to be meeting the needs of plan members. A majority of respondents, 63% say they feel their employer-sponsored benefit plans meet their needs “extremely” or “very well.” This figure is up from 56% in 2005, and is the highest level since 2002, when it was 65%.
The majority of plan members left no doubt about how much they value their health benefit plans – an overwhelming 63% choose their benefit plans over $15,000 cash. Considering that this amount far exceeds typical annual usage, the benefit plan is a security blanket for many Canadians, demonstrating the peace of mind that these plans provide to members.
Deb Mayberry, a member of The sanofi-aventis Healthcare Survey Advisory Board who works for the City of Calgary as a Business Benefits Partner in Human Resources, notes that regions or industries which are struggling to attract and retain employees are now actively and visibly marketing their benefits, because they are seen to be so valuable. “Employers are starting to promote benefits as an incentive, not a given,” says Mayberry.
Communicating costs makes sense
Respondents were also asked how much their health benefit plan costs their employer in both 1999 and 2006. Data garnered from the survey indicate there is a better awareness of cost now. Specifically, 22% of respondents didn’t know or couldn’t state a figure in 2006 versus 39% of respondents in 1999. There is a better appreciation of the true cost attributed to benefits in 2006, since 54% of respondents identify the cost of plans as over $1,200 annually, versus only 14% in 1999. The employer’s cost of a typical plan would generally exceed $1,200 per employee annually.
Opportunities for employers
Employers have the power to foster and encourage employees to be more conscious about their health by creating a healthy working environment. In a 2003 report for Health Canada [1], workplace expert Dr. Graham Lowe identified that an employee’s work environment and a company’s organizational factors play a large role and can positively influence an employee’s health and productivity.
According to The sanofi-aventis Healthcare Survey, the majority of respondents are positive about their work environment, with 87% of plan members indicating that they are “proud to work for their employer.” When asked whether they are treated fairly and with respect by their employer, 86% of respondents agree and 77% indicate that they have “enough control over how and when they do their job.”
Employer-supplied educational and support services are highly valued by employees. As emerging healthcare consumers, plan members are seeking reputable sources of information when it comes to health and preventative strategies including the workplace. In fact, 79% of respondents indicate that employee assistance programs offering stress management, substance abuse support/management, eldercare and childcare are a “somewhat” or “very high” priority. Other educational programs that focus on conditions such as high blood pressure, heart disease, cancer, diabetes, asthma or obesity are a priority for 77% of respondents. And almost two-thirds (63%) believe providing coverage for “cutting edge” drugs should be a “very high” or “somewhat high” priority for employer plans.
When asked what steps employers could take to make it easier for employees to adopt healthier behaviours, plan members most frequently identify the following: fitness/sports activities (40%); health promotion (35%); healthier food cafeteria (8%); flexible schedules (7%); and less stressful environment (6%).
Public healthcare system – Moving in the right direction
While we are a long way from the ideal, the good news is that more Canadians than not have a positive view of the public healthcare system. In fact, there has been an increase in the number of respondents who say the quality of services provided by Canada’s public healthcare system is “excellent” or “very good”: 30% this year, up from 26% last year. The number of respondents who say the quality is “good” remains at a survey high of 55%. Relatively few (15%) say the quality of medical services provided is “poor” or “very poor.”
---------------------------------------------------------------------
June 6, 2006
Enlarged Prostate is Costly to the US Healthcare System
"Enlarged Prostate is Costly to the US Healthcare System: Presented at AUA"
By Sophie Bainbridge ATLANTA, G.A. -- May 29, 2006 -- Enlarged prostate is associated with significant burden and cost to the health care system of the United States, and early detection could prevent disease progression and complications, according to a study presented at the annual meeting of the American Urological Association (AUA). Aging men are one of the fastest growing segments of the US population, and, although males and females have similar levels of illness, men tend to be underdiagnosed, said lead author Muta Manual Issa, MD, MBA, associate professor of urology, Emory University, and chief of urology, Atlanta Veterans Affairs Medical Center, Atlanta, Georgia. Men tend to think they are at a lower risk for health problems and this contributes to their lack of knowledge regarding serious health conditions, Dr. Issa said. This misperception also keeps them from seeking health care, can prevent them from changing unhealthy behaviors, and leads to increased health risks and costs, he added. "There is a lack of focus on urological disorders in men in the general medical environment and this has led to significant morbidity in aging males," Dr. Issa noted in a presentation on May 23[rd. "Managed care must begin to focus on urological diseases that are the most prevalent, to identify opportunities for improvement, based on current practice standards."
To determine the most prevalent diagnosed diseases in men aged 50 years and over, Dr. Issa and colleagues performed a retrospective study of a large national managed care claims database (Integrated Health Care Information Solutions -- HCIS) of all men in this age group as they progressed from managed care to Medicare.
Of the more than 1 million men in the HCIS sample, the researchers found that urological disorders played a substantial role in the clinical and economic burden of elderly male patients. Enlarged prostate ranked fourth in prevalence, after coronary artery disease and hyperlipidemia, hypertension, and type 2 diabetes, while prostate cancer ranked 10th, Dr. Issa reported.
The costs for prostate cancer were the highest for all diagnoses, with disease-specific medical costs at $5,542 per patient compared to $1,699 for the treatment of arrhythmias, which came in second among the 10 most common diagnoses for older men. The cost for EP was $401 per patient. The results of the study were consistent across the managed care and Medicare populations, he said.
"Urological diseases are likely to be less prioritized for medical management in elderly men, but the results of this assessment highlight the tremendous economic burden that these diseases place on health care," Dr. Issa said. "Improving the management of these diseases in elderly men may reduce the projected clinical and economic consequences." ------------------------------------------------------------------ |
June 5, 2006
Experts Attribute Growing Diabetes Epidemic to Patient/Physician Disconnect, Emphasize Team Approach
Limited understanding of disease progression and frustration with disease management contribute to the clinical challenge of meeting the rising type 2 diabetes epidemic in America, according to the Diabetes Roundtable. The Roundtable, a multidisciplinary group of diabetes experts convened by the American Association of Diabetes Educators (AADE) and the American Association of Clinical Endocrinologists (AACE), with support from Merck & Co., Inc., calls for the medical community to take a more collaborative approach to caring for people with type 2 diabetes as a way to improve both disease management and outcomes.
A survey commissioned by AADE suggests a disconnect between what patients with type 2 diabetes and primary care physicians who treat the disease believe is the state of diabetes management:
- Two-thirds of patients (69 percent) say they feel very knowledgeable or knowledgeable about managing their condition. At the same time, 81 percent of physicians surveyed say they are frustrated with the number of their type 2 diabetes patients who do not follow their treatment regimen exactly as prescribed.
- Half of patients surveyed say they have little or no understanding of their A1C level or in the past six months have not had it checked or are unsure if they have had it checked. A1C is basic lab test for evaluating glucose control, an important aspect of diabetes management.
- Fifty-nine percent of patients surveyed have worked with a diabetes educator. Almost four in five patients surveyed (78 percent) who have not worked with a diabetes educator would like to learn something from one, including how to reduce the risk of diabetes complications (39 percent), strategies for healthy eating (38 percent), and information on new type 2 diabetes medications (33 percent).
"We are not making the best use of our resources for managing type 2 diabetes. All too often patients feel they have 'failed' and feel guilty; physicians feel frustrated; no one wins," said Diabetes Roundtable member Donna Rice, M.B.A., R.N., B.S.N., C.D.E, wellness program manager, Botsford General Hospital, Novi, MI and president-elect of AADE. "Increasingly we recognize that a team-centered approach involving the patient, primary care physician, diabetes educator, behavioral scientist and endocrinologist provides the support and resources best needed to help patients manage the disease."
Source: Diabetes TEAM, May 31, 2006 -----------------------------------------------------------------------
June 2, 2006
Diabetes, related condition affect one-third of U.S. population
More than out one of three individuals has diabetes or impaired fasting glucose, a condition that increases the risk of developing diabetes, according to a new study.
The study included information on 4,761 adults, aged 20 years and older, who were classified according to their glycemic status. Findings were based on four years of data from the National Health and Nutrition Examination Survey. Dr. Catherine C. Cowie of the National Institute of Diabetes and Digestive and Kidney Diseases led a team of researchers.
More than 35% of study participants, representing 73.3 million individuals, had diabetes or impaired fasting glucose in 2002, the researchers report in the journal Diabetes Care.
May 23, 2006
Study links painkillers, hospital admissions
The use of nonsteroidal anti-inflammatories (NSAIDs) is linked to a 30% greater risk of first hospital admission for heart failure in the elderly, according to a new study.
In a four-year study, British researchers concluded that for every 1,000 people aged 60 to 84 taking NSAIDS, there would be one extra first hospital admission for heart failure. The total would jump to three additional cases per 1,000 people with people aged 70 and older with conditions such as diabetes, high blood pressure or kidney failure.
The study report is published online in Heart. ------------------------------------------------------------------
May 22, 2006
Study: Ill elderly not necessarily better off in hospitals
Hospitals that use intensive approaches to treat ill elderly patients at a higher cost to Medicare don't get better results, according to a new study by researchers at the Dartmouth Medical School.
Some patients with chronic illnesses use many more resources without better healthcare outcomes, according to the study. The Dartmouth Atlas Project examined records for Medicare enrollees who died between 2000 and 2003 and had at least one of 12 chronic illnesses, such as cancer, congestive heart failure or chronic lung disease.
The Dartmouth Atlas Project concluded that Medicare could cut spending on chronic care by as much as 30% if all hospitals used less intensive approaches. Researchers also indicated that care could be delivered less expensively and be better managed in other care settings beside the hospitals, such as nursing facilities in some instances. The study report also suggests the need for a complete overhaul of how chronic illnesses are managed and treated in the nation's healthcare system. ----------------------------------------------------------------------
May 19. 2006
Does walking test predict life span? Study says yes
The life span of an elderly person can be tied to his or her ability to walk a quarter-mile, according to new research.
Researchers at the University of Florida's Institute on Aging in Gainesville studied nearly 3,000 healthy people ages 70 to 79 and found that those who were able to complete a quarter-mile walking test in good time were three times as likely to live longer than elderly with a slow walking pace.
Furthermore, the study found that study participants with the faster walking times were much less likely to suffer from cardiovascular disease and physical disability as they aged than those who walked the slowest. In fact, participants with a slower walking pace had a three times greater risk of death and a higher risk of heart disease, limited mobility and disability than the fastest 25% of participants. Participants were tested every 6 months for nearly 5 years. -------------------------------------------------------------------------
May 16, 2006
Treatment of osteoarthritis requires drug alternatives, report says
A new report highlights the need to find alternatives for the treatment of osteoarthritis, a progressive, degenerative joint disease that affects a large percentage of elderly individuals.
Treatment currently centers on palliative care, including nonsteroidal anti-inflammatory drugs (NSAIDs). Because of controversy over these drugs, treatment alternatives are necessary. Also the lack of awareness of the disease calls for more research, according to Clare Churchill, healthcare senior analyst for London-based Datamonitor and author of "Stakeholder Opinions: Osteoarthritis ‹ Preconceptions Damage Awareness and Treatments."
The report highlights key issues in osteoarthritis therapy, including unmet needs, current treatment controversies, advancements in patient involvement and clinical trial end-points and novel therapies in the developmental pipeline. -------------------------------------------------------------------------
May 12, 2006
Researchers: Middle-age lifestyle factors foretell long-term care need
Twenty years of data indicate there is a strong correlation between nursing home admission and the presence of certain unhealthy lifestyle-related factors in middle age.
Researchers at the Institute for Health at Rutgers University in New Brunswick, NJ, found that, by and large, the same factors that increase the risk of disease and early death also increase the risk of requiring nursing home care later in life. Most of these factors ‹ including smoking, high blood pressure, physical inactivity, obesity and diabetes ‹ are modifiable, according to researchers.
The risk linked to each lifestyle-related factor was higher for middle-aged people at the start of the study than for those who were elderly. For example, a middle-aged person (someone age 45 to 64 at the start of the study) with diabetes had three times the risk of admission to a nursing home over the next 20 years, the study found. --------------------------------------------------------------------
May 11, 2006
Researchers: 1 out of 7 prescriptions not used for approved purpose
At least one out of seven commonly used prescription medications are used for off-label purposes. These other uses often lack scientific support, a new study says.
Researchers used data from the 2001 IMS Health National Disease and Therapeutic Index examination of 160 common drugs. They found that about 151 million prescriptions ‹ 21% of 725 million prescriptions ‹ were for off-label use. Furthermore, three-quarters of the off-label uses lacked scientific support, said researchers led by Randall Stafford, assistant professor of medicine at Stanford Prevention Research Center.
Off-label prescribing was most common with heart drugs (excluding those for cholesterol and high blood pressure), anticonvulsants and asthma medications. Medications for diabetes blood sugar control, pain relief and high cholesterol were the least likely to be prescribed for off-label purposes. The study report was published Tuesday in the Archives of Internal Medicine. -------------------------------------------------------------------------
May 10, 2006
Study: Socially active seniors less likely to exhibit Alzheimer¹s symptoms
Having close friendships and staying in contact with family members help prevent the risk of developing symptoms of Alzheimer's disease, according to a new study.
Many elderly people have the pathological symptoms of Alzheimer's disease but do not experience the cognitive impairment or dementia common to the disease, according to researchers at Rush University Medical Center's Alzheimer's Disease Center in Chicago,
Researchers studied 89 elderly people without known dementia who provided information about their social networks and underwent 21 cognitive performance tests each year. Their brains were analyzed after they died. The larger a person's social network, the less effect the tangles and plaques -- indicative of Alzheimer¹s -- had on their cognitive test scores.
The study is online in The Lancet Neurology. ----------------------------------------------------------------------
May 5, 2006
Elderly women who stick with calcium regimen see benefits
Milk does an elderly woman¹s body good ‹ at least the calcium part of it does. This according to a new study that says long-term calcium supplementation can effectively help reduce fractures in elderly women.
The 5-year study by researchers in Australia found that when women with an average age of 75 years old complied with their calcium supplement regimen, their risk of fractures decreased by 34 %.
The problem is most women don¹t comply with treatment over the long-term, researchers said. This, despite the fact that an increase in dietary calcium intake is thought to prevent fractures caused by the bone-thinning disease osteoporosis.
Researchers also noted that bone strength improved in study participants treated with calcium compared to those women receiving a placebo. Study results appear in the Archives of Internal Medicine. -----------------------------------------------------------------------
May 2, 2006
Study finds arthritis suffers not getting enough exercise
More than a third of adults with arthritis don't exercise at all and those who do are not doing it enough, according to new study results. Researchers at the Centers for Disease Control and Prevention said the trend is particularly disturbing because it is well known that being more active eases arthritis symptoms, including pain and disability.
While exercise has been shown to decrease pain, delay disability and improve gait and function, people with arthritis are even more likely to be inactive than adults in the general population. Yet, just 37 % of adults with arthritis met the least stringent physical activity guidelines established by a panel of arthritis experts. Both aerobic and strengthening exercises have been shown to help people with arthritis.
Fear of pain, depression, severe joint pain and the misconception that exercise can harm joints are factors that keep people with arthritis from exercising, researchers say. The study was reported in the May issue of the American Journal of Preventive Medicine. ---------------------------------------------------------------------
May 1, 2006
Study: Depression does not affect diabetes control
There is no connection between depression in elderly people with diabetes and their ability to manage their disease, according to a new study.
Researchers at SUNY Upstate University, Syracuse, NY, studied nearly 1,600 elderly diabetic Medicare beneficiaries. Participants were randomly assigned to two groups: clinical intervention and usual care. Researchers found that depression did not predict a change in blood sugar control in patients, regardless of their study group.
Researchers concluded that depression is not a factor in diabetes control and should not be used to exclude depressed elderly from programs designed to improve how well they manage their diabetes, researchers concluded. The study was published in the April issue of Diabetes Care.
***** Remember that some of the ANTIDEPRESSANT DRUGS do have problems with glucose control in diabetics who take them**** (Prozac, Paxil, Zoloft, Celexa, etc) a few that don't (Effexor XR, Remeron, Cymbalta) -----------------------------------------------------
April 27, 2006
New lawsuits target some nursing home drugs
Several "widely used" medications, including antipsychotics and osteoporosis drugs commonly prescribed to the elderly, are the focus of new lawsuits. The litigation stems from allegations of covering up associated side effects, according to a New York Times report.
Specifically, the lawsuits are targeting the antipsychotic Seroquel; the hormone replacement therapy Prempro; and the osteoporosis treatment Fosamax. Seroquel has links with weight gain and increased risk for diabetes; Fosamax has been linked with severe jaw decay; and Prempro has a link with increased risk for breast cancer, according to clinical trial data submitted to the Food and Drug Administration.
According to plaintiffs' lawyers, drug makers "hid early indications of the side effects and improperly marketed their medicines," the Times reports. --------------------------------------------------------------------
April 26, 2006
Study: Statins May Increase Chances of Getting Macular Degeneration
Recent recommendations for the aggressive use of medications to lower low density lipoprotein (LDL) cholesterol levels has contributed to a rising trend in the use of statin drugs. A study published in the January 2006 Archives of Ophthalmology evaluates the use of these drugs, specifically with regard to the risk of age-related macular degeneration (AMD).
The investigators collected data from the Cardiovascular Health Study, a population-based prospective study, to address the relationship between the use of statins and other cholesterol-lowering medications and AMD. Fundus photographs were taken in 1997 and 1998 on 4249 statin users and non-statin users in the study. 2755 of these participants were available to be classified as cases (AMD) or controls (no AMD).
The results of this study suggests no association exists between cholesterol-lowering medications and AMD progression. However, there was a suggestion that statin use might increase the risk of developing AMD. These findings are corroborated in several similar studies, including the first National Health Examination and Nutrition Survey. This evidence may seem a bit contrary to some and more than disappointing to the pharmaceutical companies who are now using the popular atherosclerotic-like theory of AMD to justify detailing statin drugs as AMD medications in ophthalmic offices.
The Doctors Klein (Beaver Dam Study) recently proposed the idea that high LDL levels and low HDL levels may actually offer protection from AMD by down-regulating LDL receptors in the Retinal Pigment Epithelium (RPE), thereby reducing the contribution of cholesterol to drusen. This line of reasoning implies that by lowering serum cholesterol levels with statins; an increased amount of cholesterol may be taken up by the RPE cells with a subsequent increased deposition in drusen and an increased risk of AMD. ----------------------------------------------------------------------
April 25, 2006
Study: Prescription drug overdoses surpass deaths from illegal drugs
The death rate from accidental overdoses involving prescription medications jumped 179% in 10 years. It now tops the rate of deaths caused by overdoes of illegal drugs such as cocaine and heroin, according to a new long-range study.
Opioid pain relievers, including codeine, morphine and Demerol, caused the majority of prescription drug overdose deaths, according to a 10-year study. The results indicate that greater overdose prevention efforts should be targeted at this group of drugs, said lead researcher Mark Mueller, an epidemiologist with the U.S. Centers for Disease Control and Prevention.
Nursing home residents typically use multiple and different prescription drugs at one time.
Between 1994 and 2003, accidental prescription drug overdoses increased from 1.9 out of 100,000 deaths to 5.3 per 100,000 deaths. Unintentional overdose deaths caused by illegal drugs increased 121% over the 10-year period.
Too many people think if one pill does this much good, if I take two it will be twice as good. This can be deadly for the older patient since, just due to the fact of age, so many organ systems change. Another point to think about as mentioned above, “Nursing Home residents typically use multiple and different prescription drugs at one time“, I want you to understand most of the time I see out patients in my office setting they are on many more drugs than the average nursing home patient. This critical area in Geriatric Care is totally over looked or monitored. Also, DEMEROL IS TOTALLY CONTRAINDICATED in anyone over 65 years of age. -----------------------------------------------------------------------
April 20, 2006
Cancer survivors at increased risk of disability, study finds
Elderly women who are cancer survivors are at greater risk of some functional limitations, according to the results of a new study.
Researchers who examined data from nearly 26,000 women with a median age of 72 found that cancer survivors were more likely to report trouble doing heavy household work than those who had not suffered from the disease ‹ 43% compared with 31%, respectively. Also, cancer survivors were more likely to be unable to walk a half-mile or walk up and down stairs.
The findings underscore the need for interventions "to prevent and reverse functional decline among elderly long-term cancer survivors," wrote a team of University of Utah researchers. Their study report is published in current issue of the Journal of the National Cancer Institute. -------------------------------------------------------------------------
April 18, 2006
Nerve stimulation treatment helps incontinence, study finds
The use of a nerve stimulation technique is a safe and effective treatment for urinary "urge" incontinence, researchers say.
Investigators at the University of Michigan in Ann Arbor found that 90% of the patients treated with a technique known as sacral neuromodulation experienced at least 50% improvement in symptoms and quality of life. Sacral neuromodulation also was linked to reductions in the average number of leaking episodes and in the number of pads used per day.
With the technique, a battery-powered pulse generator provides nerve stimulation via implanted electrodes. Exactly how this therapy works is unclear. But researchers say it could be an effective alternative to drugs or surgery.
Study findings appeared in the publication Urology. -----------------------------------------------------------------------
April 11, 2006
Study examines brain's link to walking
The brain affects walking ability in the elderly, a new study finds. The research suggests doctors should pay more attention to the cognition-walking connection.
For the study, Roee Holtzer, assistant professor of psychology and neurology at Albert Einstein College of Medicine in New York, and colleagues gave cognition tests to 186 people aged 70 and older. They then watched them as they walked through a corridor on a specially designed mat.
The fastest walkers had higher scores on certain cognitive tests, including those that measure memory and planning abilities. Higher levels of verbal ability also were linked to faster walking in some cases. The findings appeared in the March issue of the journal Neuropsychology. --------------------------------------------------------------------
April 10, 2006
Quality of Medical Care Received by Older People with Arthritis is Poor
The quality of medical care received by older people with arthritis is relatively poor and they receive recommended information about potential hazards of their medication less than half the time, according to a study by RAND Corporation.
In the first study to measure the quality of arthritis care based on patient interviews, researchers from RAND Health, the David Geffen School of Medicine at UCLA and the Greater Los Angeles VA Healthcare System found:
- Older patients received the recommended care for arthritis just 57 percent of the time.
- Just 44 percent of the patients studied received the recommended information about the safety of their medication. In contrast, 64 percent had received some treatment for their arthritis.
- Most of the arthritis care was provided to study participants by primary care physicians, with only 12 percent having seen a rheumatologist at least once during the period examined.
Source: RAND Corporation, April 4, 2006 http://www.rand.org/news/press.06/04.04.html
-------------------------------------------------------------------
April 8, 2006
“Earth-shaking” Findings Could Prevent Strokes, N.H. Admissions
Treating blocked carotid arteries, even if there are no negative symptoms present, significantly improves mental functioning, researchers say. Inserting a stent will prop open the arteries, the major source of blood flow to the brain.
"What we found was earth-shaking," presenter Dr. Rodney D. Raabe, of Sacred Heart Medical in Spokane, Washington, said in a published report. "The findings will change the way we think about carotid artery disease, how it is treated and how patients are classified".
"About three-fourths of the 40 study subjects had undergone 6-month evaluations, including an extensive battery of neurocognitive tests", Raabe said. Study results were discussed Friday at the Society of Interventional Radiology's annual meeting in Toronto.
"Remarkably, they all showed significant cognitive improvement, especially in executive function, their ability to think abstractly, make judgments and reason," Raabe said. "Some patients whose functioning was so poor that they were being considered for nursing home placement, are now doing quite well living independently at home."
Treatment of carotid arteries currently takes place in the United States only to prevent stroke. "Patients with early dementia may actually be experiencing the results of blocked carotid arteries and their condition could be reversed", Raabe said.
March 31, 2006
Stigma concerns delay Alzheimer's diagnosis, survey finds
Stigma about Alzheimer's disease can delay its diagnosis of for up to six years, a new study finds.
When people with Alzheimer's were concerned about the stigma, a diagnosis occurred on average 3.5 years after symptoms appear. The delay averaged six years when caregivers were similarly worried, according to a new survey from the Alzheimer¹s Foundation of America, a national nonprofit organization.
The delay is serious because it ultimately hurts the management and treatment of the disease, said Erick J. Hall, CEO of the foundation.
The survey was based on interviews with a nationwide cross section of 539 U.S. adults, aged 18 or older, who are caregivers currently caring for a loved one with Alzheimer's disease. See more key survey findings at http://www.alzfdn.org/ -------------------------------------------------------------------------
March 27, 2006
Study: Effectiveness of the flu shot tied to older person's state of mind
The value of the flu shot in elderly people relies heavily on the mental state of the person, a new British study suggests.
Researchers at the University of Birmingham's School of Sport and Exercise Sciences found that one month after receiving the flu shot, bereaved elderly showed a 69% lower antibody response to one flu strain and an 83% lower response to a second strain. Unmarried participants had a 74% lower antibody response to one strain of flu, compared to those who were happily married.
While it is difficult to change someone's bereavement or marital status, there are measures, such as counseling, to help people cope more effectively, said study lead author Anna C. Phillips. These measures might help improve a person's emotional and physical well being. For elderly in nursing homes, a flu shot cuts the risk of death by 75%-80%, according to the National Institutes of Health. -------------------------------------------------------------------
March 20, 2006
Memory-loss protein could lead to early detection of Alzheimer's
The identification of a specific protein in the brain could improve the detection and prevention of Alzheimer's disease in the future, researchers say.
Scientists at the University of Minnesota have identified a mass of amyloid-b peptides in the brains of laboratory mice suffering from memory loss. The protein essentially puts the neurons in the brain "to sleep," researchers note, causing memory loss associated with Alzheimer's. Scientists have for years pointed to the build up of plaques or proteins causing blockages in the brain as an indication of Alzheimer's disease,
Although this current research only applies to lab mice, the discovery could enhance health practioners' ability to diagnose human patients who are at risk for Alzheimer's long before they get it. Health Practioners then could focus on better prevention and treatment, said study lead author Dr. Karen Hsiao Ashe, professor of neurology and neuroscience at the University of Minnesota.
The study results are in the newest issue of Nature. ---------------------------------------------------------------------
March 16, 2006
Blood pressure meds may reduce Alzheimer's risk
Medications used to lower blood pressure, particularly diuretics, may help lower the risk of developing Alzheimer's disease, according to new study results.
Researchers studying nearly 3,000 elderly people found that among people taking anti-hypertensives, there was an overall 40% reduction in the risk of developing Alzheimer's disease over a three- to four-year period. The study is reported in the March 13 online edition of the Archives of Neurology.
Drugs that lower blood pressure include diuretics, beta-blockers and calcium channel blockers. Diuretics appeared to offer the greatest benefit to study participants, but there was also a reduced risk with the use of calcium channel blockers, said study co-author Peter P. Zandi, an assistant professor at Johns Hopkins University's Bloomberg School of Public Health. --------------------------------------------------------------------
March 14, 2006
Study: Depressed elderly more likely to suffer mental decline
Elderly people with symptoms of depression are more likely than those without depression to develop mild cognitive impairment (MCI) within six years, according to new study results.
Researchers at the San Francisco VA Medical Center and the University of California looked at 2,220 participants in the Cardiovascular Health Study, a longitudinal prospective study of adults 65 and older and measured the elderly subjects' depressive symptoms using a standard depression scale. Six years later, a team of dementia experts found that 19.7% of subjects with moderate to high depression had developed MCI. Only 10% of subjects with no depressive symptoms went on to develop MCI, and 13.3% with low depressive symptoms had cognitive impairment.
Researchers noted that the findings were consistent among men and women, the younger and the older, and among subjects with and without vascular disease. In addition, the study showed that the greater the degree of depression, the more likely the impairment.
"This is important, because mild cognitive impairment often precedes dementia," said Deborah Barnes, a mental health researcher at SFVAMC and lead author of the study report. Approximately 50% of patients diagnosed with MCI go on to develop dementia within three years, according to study findings. ----------------------------------------------------------------------
March 13, 2006
Happy Birthday Mom.... Mary Eleanor Neel (3/13/1914 - 10/22/2004) ------------------------------------------------------------------------
March 13, 2006
Genes may explain elderly vision loss
Age-related macular degeneration, a major cause of vision loss and blindness among the elderly could be the result of two gene mutations.
While not a cure for AMD, scientists believe the discovery could bring doctors closer to therapies that could help prevent or treat the disease. Macular degeneration causes the deterioration of the macula, a part of the retina.
A research team from Columbia University in New York City found specific variations in the two genes that may account for about three-quarters of all cases of age-related macular degeneration. The study suggests that the immune system plays a crucial role in the development of macular degeneration, because the presence of the gene variations alone doesn't mean a person will develop AMD. A trigger must be present, as well.
An estimated one-third of Americans will develop some form of macular degeneration by the time they are age 75. The research was reported online in Nature Genetics. ---------------------------------------------------------------------
March 10, 2006
Spouse’s Hospitalization Increases Partner’s Risk of Death
Hospitalization of a spouse for a serious illness also increases their partner’s risk of death. Further, the risk is greater with certain diagnoses, such as dementia, stroke, and hip fracture, according to a new study sponsored by the National Institute on Aging (NIA) at the National Institutes of Health (NIH).
The report, by Nicholas A. Christakis, M.D., Ph.D., M.P.H., of Harvard Medical School, and Paul D. Allison, Ph.D., of the University of Pennsylvania, is the first to measure a link between a spouse’s hospitalization and increased mortality of their partner across a comprehensive range of spousal diseases. The findings, says Christakis, were striking. “When a spouse is hospitalized, the partner’s risk of death increases significantly and remains elevated for up to two years,” he notes. The study is published in the Feb. 16, 2006, issue of the New England Journal of Medicine.
Christakis and colleagues studied more than half a million couples over 65 years old who were enrolled in Medicare from 1993 through 2001.
- Overall, having a sick spouse is about one fourth as bad for a partner’s health as having a spouse actually die. Some spousal diseases, such as hip fracture or psychiatric conditions, were nearly as bad for partners as it would be if the spouse actually died.
- The period of greatest risk is over the short run, within 30 days of a spouse’s hospitalization or death, the researchers noted, when the risk of death upon a spouse’s hospitalization is almost as great as that when a spouse dies. The mortality risk increased with age and, for women of a hospitalized husband, with poverty.
- The illness responsible for the spouse’s hospitalization also matters. For example, among men with hospitalized wives, if their wife is hospitalized with colon cancer, there is almost no effect on the husband’s subsequent mortality. But if the wife is hospitalized with heart disease, the risk of death for a husband is 12 percent higher compared to the wife not being sick at all. If one’s wife is hospitalized with psychiatric disease, a partner’s risk of death is 19 percent higher. And if one’s wife is hospitalized with the principal diagnosis of dementia, mortality risk for the husband is 22 percent higher. Similar effects are seen in women whose husbands are hospitalized.
- The more a disease that causes a hospitalization interferes with the patient’s physical or mental ability, regardless of the extent to which it is deadly, the more of an impact it may have for the partner of the ill person, the researchers suggest.
Source: The National Institute on Aging and the National Institutes of Health, February 15, 2006 ----------------------------------------------------------------------
March 9, 2006
Heartburn drugs may cause serious diarrhea...
Heartburn sufferers, listen up: Acid-fighting drugs might spell relief, but they could leave a less-welcome gift -- diarrhea.
People taking proton pump inhibitors and H2 blockers have greater risk of infection from a potentially dangerous diarrhea bug known as Clostridium difficile, or C-diff, reports researcher Sandra Dial, MD, MSc, a researcher at McGill University in Montreal. Her study appears in this week's issue of The Journal of the American Medical Association.
Proton pump inhibitors include Prilosec, Prevacid, and Nexium among others. H2 blockers include drugs such as Zantac, Pepcid, and Tagamet. These are the main medications offered to people suffering from stomach acid problems such as gastritis, GERD (acid reflux disease), or heartburn. They work to suppress stomach acid production which helps to alleviate discomfort.
Clostridium difficile is prevalent in the environment and especially in hospitals and nursing homes. Spores from C-diff enter our bodies through the mouth, which is the entry way for the gastrointestinal tract. Diarrhea caused by C-diff is a result of overgrowth of the C-diff bacteria in the colon, or large intestine. It has generally been associated with antibiotic use, which can kill "good" bacteria in the colon which keeps C-diff at bay. Infection has also been associated with stays in hospitals and nursing homes where it is easily passed to others.
C-Diff Severity
The incidence and severity of diarrhea caused by C-diff has increased dramatically, according to recent data, writes Dial. Diarrhea caused by C-diff can be severe, with a cramping form of intestinal inflammation known as colitis.
"Clostridium-difficile-associated disease is becoming an important public health issue," writes Dial. Gastric (stomach) acid operates as a major defense mechanism against ingested bugs. But when people take gastric acid suppressors the stomach's normal acidity is lost, and this defense mechanism may become diminished, she explains.
Dial's study -- the largest study thus far of this risk factor -- looked at whether these drugs had any association with community-acquired C-diff infection. She and her colleagues examined data from 3 million patients of 400 general practioners in the U.K. from 1994 to 2004. There were 1,672 identified cases of C-diff, with numbers increasing from less than one per 100,000 in 1994 to 22 per 100,000 in 2004.
Those patients taking proton pump inhibitors were nearly three times more likely to acquire a C-diff infection, Dial reports. Patients taking another type of acid-fighting drug -- H2 blockers like Pepcid and Zantac -- were twice as likely to get a C-diff infection.
Other studies have shown that antibiotic use increases risk for C-diff infection. However, in her study, antibiotic use was seen in only 37% of C-diff cases. The study only demonstrated an association between the use of these medications and the risk for getting diarrhea from C-diff. It did not prove how or why this happened. ---------------------------------------------------------
March 8, 2006
Optimists have better heart health than pessimists, study suggests
Elderly men with an optimistic attitude seem to have better cardiovascular health than their peers who are more pessimistic, according to a new study.
Dutch researchers who studied men aged 64 to 84 for up to 15 years found that men determined to be optimists at the outset in 1985 were 55% less likely to die of heart disease or stroke by 2000 as men who were more pessimistic by nature. Other major factors, including general health, smoking and family history of cardiovascular disease were also considered.
Researchers also noted that optimistic men tend to exercise more and give higher ratings to their overall health. The findings were published in the Archives of Internal Medicine. -----------------------------------------------------------------
March 7, 2006
Vitamin D, calcium cut risk of falling among older women, study says
A new study finds that vitamin D supplements along with calcium reduce the risk of falling among older women. This follows two reports that concluded older women do not benefit greatly from supplements and calcium.
The latest study, whose findings appear in the Archives of Internal Medicine, followed 199 men and 246 women 65 or older who took either vitamin D and calcium daily, or a placebo, over three years. Among women, a vitamin D and calcium combination reduced the risk of falls by 46%. No significant reduction was seen in men.
Last month, A study of postmenopausal women over age 50 found that those who took vitamin D supplements achieved a small but significant improvement in hip bone density but no major reduction in their risk of hip fracture until they reached their 60s. Another study found that daily calcium plus vitamin D had no effect whatsoever on colorectal cancer risk in the same group of women. The studies appeared in the Feb. 16 issue of the New England Journal of Medicine. --------------------------------------------------------------
March 6, 2006
Living, breathing air pollution puts elderly at greater risk for diseases
Don't breath so deeply, say doctors at the National Institutes of Health -- especially if you are elderly and reside near a busy highway or street or a power plant.
Results from a new four-year study of 11.5 million Medicare enrollees show that short-term exposure to fine particle air pollution significantly increases their risk for cardiovascular and respiratory disease. Pollution sources include motor vehicle exhaust and power plant emissions.
The study data indicate that small increases in fine particle air pollution increased hospital admissions for heart and vascular disease, heart failure, chronic obstructive pulmonary disease and respiratory infection among people over 65.
Participants over 75 years of age experienced even greater increases in admissions for heart problems and chronic obstructive pulmonary disease compared to those between 65 and 74 years of age, noted National Institutes of Health Director Elias A. Zerhouni, M.D. The study is published in the March 8 issue of the Journal of the American Medical Association.
February 28, 2006
More Propoxyphene (Darvocet) Problems....
WASHINGTON, D.C. - Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than two thousand accidental deaths, is physically addictive and is no more effective than safer alternatives.
Data from the Federal Drug Abuse Warning Network, which provides autopsy information from medical examiners in the United States, has found that 5.6 percent of all drug related deaths were related to propoxyphene during the past 19 years. In 2004, 23 million prescriptions were filled, making propoxyphene the 12th most commonly prescribed generic drug in the United States. Four companies, Mylan, Mallinkrodt, Teva and QLT account for more than 91% of U.S. prescriptions.
Propoxyphene has been associated with 2,110 reported accidental deaths in the United States since 1981. A large proportion of the accidental deaths attributed to propoxyphene each year occur because most of the of the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression. Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.
"The number of deaths involving propoxyphene in the U.S. alone is striking," says the petition, filed by Public Citizen and two Swedish experts on propoxyphene, Drs. Ulf and Birgitta Jonasson. The entire petition can be viewed at www.WorstPills.org.
Last year the British government announced a phased withdrawal of the drug because of the drug's negligible effectiveness and the high risk of overdose and death. "It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive," the British government stated.
In addition to heart toxicity, popoxyphene is a drug that has been deemed inappropriate for prescription to the elderly because the central nervous system-related adverse events that have been found to increase the likelihood of falls and fall-related fractures in the elderly. Studies have shown that propoxyphene use is widespread in the institutionalized population, in emergency rooms and in community-dwelling older people, populations, in whom propoxyphene is most dangerous.
"The Food the Drug Administration should immediately begin phasing out the use of propoxyphene," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "Millions of people, many of them elderly, are being put at risk when using this drug when there are safer, more effective alternatives available. We agree with the British government's conclusion that the efficacy of this product 'is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.'" ------------------------------------------------------------------
February 27, 2006
Common flu is resistant to two medications, experts say
This most common type of flu has become nearly 100% resistant to two commonly used antiviral medications, according to disease control experts.
In previous years, amantadine and rimantadine failed against H3N2 (influenza A) between 2% and 15% of the time in North America. This season the number of resistant cases has climbed to more than 92%, according to a recent article in the New England Journal of Medicine.
Experts contend that this year's flu strains are still responsive to two other antivirals, Relenza (zanamivir) and Tamiflu (oseltamivir). Also, flu vaccines continue to be effective, officials say. -----------------------------------------------------------------
February 23, 2006
Study: Many elderly women fail to receive bone density tests
Less than one-third of elderly women have undergone valuable bone density screening, according to a new study.
Researchers at the Medical College of Wisconsin found that just 27% of women ages 65 to 70, 25.6% of women ages 71 to 75, and less than 10% of women older than 75 underwent the test. Older women are at the highest risk for hip fractures.
Most doctors' lack of understanding of the importance of bone density testing and the positive effects of osteoporosis treatment primarily could contribute to the under testing, the researchers noted.
The study appears in the March issue of the Journal of the American Geriatrics Society. ----------------------------------------------------------------
February 21, 2006
Shy people more likely to get Parkinson's, study suggests
New research finds that a cautious, risk-averse person may be more at risk for Parkinson's disease.
The study was actually conducted to examine the effects of tobacco, alcohol and caffeine on the condition. Researchers examined the drinking and smoking habits and consumption of caffeine of 106 people with Parkinson's and 106 unaffected people. They also looked at answers from three personality tests measuring depression, anxiety and the desire to seek sensational experiences.
They were not surprised to find the Parkinson's subjects drank less, smoked less and consumed fewer beverages with caffeine. But they were struck that people with Parkinson's scored higher on test for anxiety and depression and lower on the sensation-seeking test.
Such a finding could suggest that shyer and more cautious people are more at risk for the disease. The study appears in the February issue of the Journal of Neurology, Neurosurgery and Psychiatry. -------------------------------------------------------------------
February 10, 2006
Uterine cancer cases increase among older women in Europe, report says...
Cases of uterine cancer among older women are rising in Europe, researchers say.
Uterine or womb cancer cases have risen by 30% among women aged 60 to 79 in less than a decade, according to a report. Several reasons account for this increase: higher body weight, early puberty, late menopause and estrogen-only hormone replacement therapy. The breast cancer drug tamoxifen also raises the odds of developing uterine cancer.
Detecting cancer of the uterus early when it is most treatable has lifted five-year survival rates to 77% in Britain. Hysterectomy, or removal of the womb, is the standard treatment. Chemotherapy also may be part of the treatment depending on the stage of the illness.
"There are good improvements in survival but there is quite a sharp increase in incidence in the age group most affected by the cancer," said Lucy Boyd, an epidemiologist at the charity Cancer Research UK in London and the author of the report. ---------------------------------------------------------------
February 8, 2006
Poor Emotional Health is Barrier to Preventive Care in the Elderly
Poor emotional health, such as symptoms of depression and anxiety, may significantly reduce the likelihood that elderly patients will receive preventive health services, according to a study led Joshua Thorpe, Ph.D., MPH, assistant research professor in the School of Nursing and senior fellow in the Duke University Center for Aging. The researchers said their findings lead them to recommend that physicians actively screen older patients to determine if they might be experiencing symptoms of psychological distress.
- The study included an analysis of survey data from approximately 3,700 elderly individuals – a group that represented 33.8 million community-dwelling elderly living in the United States.
- Results showed that distressed elderly were 30 percent less likely to receive an influenza vaccine, 23 percent less likely to receive an annual dental check-up, and distressed women were 27 percent less likely to undergo a clinical breast examination. The researchers controlled for many outside factors that could affect patient behavior, including age, sex, race/ethnicity, marital status and education.
- Psychologically distressed women are also less likely to receive mammograms. For this preventive service, the study focused on women ages 65 to 69. Of that group, women under distress were 32 percent less likely to receive the test. Because the respondent population for mammograms was smaller than for other services in the study, Thorpe said, while somewhat significant, the relationship between mammography and distress should be studied in greater depth.
- The prevalence of depression among the elderly ranges from 10 percent to 50 percent, depending on their health, activity level and living situation, according to the Hartford Institute for Geriatric Nursing. However, physicians screen for psychological distress in only 14 percent of elderly primary care visits, according to previous research published in Medical Care. According to that previous research, physicians used a formal screening tool in only three out of 389 encounters.
Source: Duke University Center for Aging, February 1, 2006 http://www.dukemednews.duke.edu/news/article.php?id=9471 ---------------------------------------------------------------------
Commonly prescribed drugs may affect mental function of elderly
Anticholinergic drugs, which are commonly prescribed for various ailments in the elderly, may cause mild mental impairment, according to new research.
French scientists who studied patients 60 years of age and older found that those who took anticholinergic drugs were at risk of developing mental impairment, even though their risk of dementia did not increase.
Anticholinergic drugs are prescribed for a variety of conditions, including nausea, spasms, irregular heart rhythm, allergies, asthma, pain, vertigo, high blood pressure, Parkinson's disease, ulcers and certain mental disorders.
Study participants using anticholinergic drugs showed significantly worse performance in simple reaction time, attention, memory, narrative recall and verbal fluency.
The study report is published in the online issue of the British Medical Journal. ------------------------------------------------------------------------
February 6, 2006
Study: Active elderly less likely to develop dementia
New research offers more evidence that exercise helps the elderly stay young in mind and body.
Elderly people who exercise regularly are less likely to develop dementia than their sedentary peers, according to new research reported in the Annals of Internal Medicine.
The study, which involved nearly 2,000 people who were 65 or older at the start, suggests that walking just three times a week for 15 minutes each time will cut the risk of dementia by nearly 38%. ---------------------------------------------------------------------
February 4, 2006
Alzheimer's could result from early division of nerve cells, study suggests
Scientists may have uncovered a key relationship in their understanding Alzheimer's disease.
A new study in mice suggests that Alzheimer's may be triggered when adult neurons, or nerve cells, try to divide. This finding could lead scientists to new ways of treating it.
It is known that nerve cells or neurons affected by Alzheimer's often start to divide before they die. The study reveals that, in animal models of Alzheimer's, the abnormal cell division begins a long time before markers of the disease, such as amyloid plaque, appear.
Cell division occurs through a process called the cell cycle. Stop the cycling and you may be able to stop the nerve cells from dying prematurely, according to research leader Karl Herrup of Case Western Reserve University in Cleveland. The work was conducted at Case's Alzheimer's Disease Center. --------------------------------------------------------
 Happy New Year!
January 9, 2006
Study: 'Bad' cholesterol may not be so bad for elderly
Higher levels of LDL cholesterol, so-called "bad" cholesterol, may be better for the elderly than lower levels of LDL, according to a new study.
While high levels of LDL are linked to heart disease, older men and women with higher LDL cholesterol levels may have a lower risk of fatal heart disease, says a study in the Journal of the American Geriatric Society.
Researchers at the University of Padua, Italy, studied more than 3,000 men and women age 65 years old or older for up to 12 years and found that higher levels of LDL were associated with decreasing mortality risk in women. For both men and women, the risk of fatal heart failure decreased with higher levels of LDL.
The findings "add to the uncertainty of the role of elevated levels of LDL cholesterol as a risk factor for mortality in old people," researchers said in the study report. -------------------------------------------------------
December 25, 2005
 Merry Christmas and Happy New Year!
December 15, 2005
Study: Sleep, social ties cut risk of age-related diseases
Elderly women who get a good night's sleep or have remained relatively social or both have lower levels of a protein linked to numerous age-related diseases, including Alzheimer's and cancer, according to new research.
Interleukin-6 is an immune system protein that promotes inflammation and tends to increase with age. People who have relatively high levels of the protein are at greater risk a variety of diseases, including osteoporosis, rheumatoid arthritis, heart disease, Alzheimer's disease and cancer.
"You don't need to have both [good quality sleep and social engagement] in order to have low levels of IL-6 -- having high levels of one is enough," according to Dr. Elliot M. Friedman, lead researcher from University of Wisconsin, Madison.
Friedman and colleagues examined the interplay between social engagement, sleep quality, and blood levels of IL-6 in women between the ages of 61 and 90.
The report on the research is in the online issue of the Proceedings of the National Academy of Sciences. -----------------------------------------------------------------
December 13, 2005
Study reveals success of new treatment for stroke recovery
Alternately applying heat and cold to the paralyzed arms and hands of stroke patients helps improve function, according to the results of a new study.
This is the first time the technique called thermal stimulation has been tried as a method of stroke rehabilitation, according to Taiwanese researchers. Thermal stimulation is used in orthopedic rehabilitation and in the treatment of swallowing difficulties when caused by a stroke or other conditions.
As many as 85% of stroke patients suffer impairment of an upper limb, and although rehabilitation techniques currently used can be effective, they are also costly and complicated, according to Fu-Zen Shaw, the lead author of the study report published in Stroke.
For the study, researchers gave half of the stroke patients standard rehabilitation therapy and the other half standard treatment plus thermal stimulation.
Patients had five 20- to 30-minute sessions a day for six weeks with alternate applications to a hand and wrist of a cold pack (with a temperature just above freezing) and a hot pack (with a temperature of 167 degrees Fahrenheit).
The thermal stimulation can activate a large brain area helpful in readjusting the motor control circuitry, according to Shaw. The treatment also generates reflexive behavior, which gives stroke patients hope.
The study showed that the thermal stimulation patients had significantly better recovery on four of six measures of function, including changes in sensation, grasping strength and ability to bend the wrist, the researchers said. ---------------------------------------------------------------------
December 12, 2005
Report: Life expectancy up, health problems up
The National Center for Health Statistics reported an increase in the life expectancy rate, but it also found a disturbing trend in the health of aging Americans.
Americans' life expectancy has increased by nearly two years since 1990. A child born in 2003 can expect to live 77.6 years on average, up from 75.4 years in 1990 and 77.3 in 2002.
But the study report said that half of Americans ages 55 to 64, a group that includes the oldest of the baby boomers, have high blood pressure, and 2 in 5 are obese.
People born in the 1930s had lower rates of high blood pressure and obesity than the Americans born in the 1940s. The hypertension rate in the 1930s group was 42% compared to 50% for the 1940s group; and the older group's rate of obesity was 31% in 1990, compared with 39% for the 1940s group now.
The report presents the latest data collected by the National Center for Health Statistics and other health agencies and organizations. ---------------------------------------------------------------------
December 8, 2005
CDC: More elderly hospitalized for pneumonia
The number of elderly hospitalized for pneumonia has increased significantly in recent years, according to a report from the U. S. Centers for Disease Control.
Hospital stays for people aged 65 to 84 suffering from pneumonia jumped 20% between the late 1980s and 2002, the CDC report said. Researchers found that one in 83 people aged 65 to 74 is hospitalized each year because of pneumonia. The incidence rises to 1 in 38 people in the 74 to 84 age bracket, and 1 in 20 for those 85 and older.
Researchers cite the increasing number of elderly with chronic medical conditions as a contributing factor in the rise in hospitalizations for the illness, which is caused by viruses, bacteria and other organisms that produce inflammation. About 80% of older adults hospitalized for pneumonia also grapple with at least one other chronic disease, according to the study. ----------------------------------------------------------------------
December 7, 2005
Study: OTC pain medication helps elderly with dementia
Giving the common over-the-counter painkiller acetaminophen to elderly people suffering from dementia may actually help them become more active and socially engaged, a new study in the Journal of the American Geriatrics Society suggests.
For the study, researchers gave acetaminophen to a small group of nursing home patients who had moderate to severe dementia. They found the medication helped changed some of the patients' behaviors.
For example, some residents with dementia spent less time in their rooms and more time watching television, listening to music, reading or performing "work-like" activities when given the pain medication.
While chronic pain is common among the elderly, the diagnoses and treatment of chronic pain in those with Alzheimer's disease and other forms is often difficult because they may be unable to express what they are feeling, say study authors, who were led by Dr. John T. Chibnall of the Saint Louis University School of Medicine in Missouri. ------------------------------------------------------------------
December 6, 2005
Report: Conventional antipsychotics could harm elderly
Conventional antipsychotic medications may be even more dangerous than atypical antipsychotics for elderly people with dementia, a new report suggests.
Dr. Philip S. Wang's group at Brigham and Women's Hospital in Boston evaluated data from patients 65 or older who were treated between 1994 and 2003. Data included 9,142 patients who used a conventional antipsychotic drug and 13,748 who used an atypical antipsychotic drug.
In the first 180 days of use, 17.9% of those using a conventional agent (such as Haldol or Thorazine) died, compared with 14.6% of those who used an atypical antipsychotic (such as Zyprexa or Seroquel). Study information is available in the Dec. 1 New England Journal of Medicine.
The U.S. Food and Drug Administration issued an advisory in April that cautioned that the use of atypical antipsychotics increases mortality in the elderly. But it did not include conventional antipsychotics because there was not yet enough trial data, Wang said. -----------------------------------------------------------
December 2, 2005
Public trusts nurses over doctors, clergy, Gallup poll finds
Nurses were tops again in the latest Gallup poll of the most "ethical" professions. They have ranked first in the poll in six of the last seven years. Only in 2001 -- the year of terrorist attacks in New York City and elsewhere -- did firefighters eclipse nurses as the most ethical profession.
In the most recent poll, druggists/pharmacists came after nurses and were followed by medical doctors, high school teachers, police officers and clergy, according to the survey of 1,002 American adults. -----------------------------------------------------------------------
July 14, 2006
Evista Might Increase Risk of Stroke Death, Study Finds
Eli Lilly & Co.'s Evista drug may increase the risk of blood clots and fatal stroke in older women, a finding that may discourage its use to prevent bone- thinning osteoporosis in some patients.
Women who took Evista had a 49 percent increase in their risk of dying from stroke compared with those taking a placebo, a study found. Their chance of getting blood clots from use of the drug, known chemically as raloxifene, rose by 44 percent in the research involving 10,101 women in 26 countries.
Patients will have to balance those risks against the protection Evista offers against osteoporosis and breast cancer, said Lori Mosca, director of preventive cardiology at New York Presbyterian Hospital. Women in the study who took Evista were 44 percent less likely to develop breast cancer, a finding that mirrored previous studies.
``Usefulness of this drug in any woman will depend on her personal risk of breast cancer, osteoporosis, stroke and blood clots,'' said Mosca, who co-wrote the study, in a telephone interview today. ``It's not a one-size-fits-all answer.''
The study will be published tomorrow in the New England Journal of Medicine.
Evista was approved in 1997 to prevent osteoporosis, which can lead to fractures. Researchers suspected that it might also have an effect on breast cancer and heart disease, like other drugs that modify the effects of the female hormone estrogen such as tamoxifen.
The most recent study, led by Elizabeth Barrett-Connor of the University of California, San Diego, followed post- menopausal women who had existing heart disease, or risked developing it because of smoking or conditions such as diabetes.
Deaths
After about 5 1/2 years, there was no difference in rates of heart attacks or heart-related hospitalizations and deaths among Evista users and those who received a placebo. While strokes in the treated and untreated group were in the same range, 59 women who took Evista died of the brain illness, compared with 39 women who got a placebo.
Lilly released partial findings from the study April 12, at the request of the U.S. Food and Drug Administration. Lilly said then that while overall stroke rates in the study were low, Evista was associated with ``an increase in stroke mortality.''
Data from the study, including the precise increase in risk of stroke death, were not released because the findings had not yet been reviewed by experts, said Keri McGrath, a Lilly spokeswoman, in a telephone interview today.
Reviewing the Label
Lilly recommended then that doctors consider women's stroke risk when prescribing Evista, and the company is reviewing the drug's label with the FDA, she said.
The label doesn't mention risk of death from stroke. The company has communicated Evista's risks with doctors, pharmacists, other health professionals and patients through its sales force and direct mail, McGrath said.
The breast cancer finding in the most recent study supported the result of a different study, released in June, which said Evista is as effective against breast cancer as tamoxifen, the standard treatment for that disease.
Lilly has said it is planning to apply to the FDA for approval to market the drug as a breast cancer preventative.
Older women with a family history of stroke or high blood pressure should consider using Evista alternatives for osteoporosis, such as supplemental Calcium (Calcium Citrate, Citracal + Multivitamin), when treating patients at elevated stroke risk, the researchers said.
_______________________________________
July 8, 2006
Brief intervention reduces symptoms of depression
Taking a page from the treatment book on alcohol abuse, researchers from the University of Washington have successfully tested a brief, low-cost intervention to deal with depression, the No. 1 mental health problem in the United States.
Students with mild depression who received the intervention through the mail reported a 20 percent reduction in the severity of their symptoms one month later, compared with an 8 percent drop for another group that was not treated. In addition, feelings of hopelessness among the students who received the brief intervention dropped 31 percent, while those emotions only fell 7 percent for the other students.
Brief interventions have been utilized effectively in alcohol treatment for a number of years, and the concept transferred to depression, said Irene Markman Geisner, lead author of a study appearing in the current issue of the Journal of Consulting and Clinical Psychology and a psychology doctoral student at the University of Washington.
"There is a tendency to think that college students are a privileged group with no real problems. But depression is a serious concern among college students," said Mary Larimer, a study co-author and UW associate professor of psychiatry and behavior sciences. "Our counseling centers are overrun with depression, as well as other problems."
"At any given time, up to 35 percent of college students have depressed moods," said Geisner. "They are not clinically depressed, per se, but their mood clouds their academic and social lives and puts them at much greater risk for future clinical depression."
For the study, nearly 1,200 students were screened for symptoms of depression. More than 200 met the criteria for depression, and 177 were recruited and completed a more-detailed baseline assessment for depression and how they cope with it.
A week after this assessment, half of the students received the intervention that consisted of a personalized feedback letter and a brochure. The letter began with a paragraph that told the students the concerns they reported during the assessment were consistent with depression and that this is a common experience for college students. The letter then reflected the personal concerns students expressed. It also listed the various coping strategies each was already using to deal with his or her depression, and indicated that there were many things the students could do to reduce depression.
The brochure, prepared for the study, listed six types of strategies students could use -- social support, pleasant activities, exercise, self-help literature, meditation and spirituality, and medication -- to help relieve their depression. The brochure also gave the students examples of problem solving and how to change their thought processes. Finally, it provided a list of on- and off-campus treatment resources.
The other group of students received thank-you letters for participating in the study. These letters listed common depression symptoms and provided a list of on- and off-campus telephone numbers students could call for help.
One month later, both groups were reevaluated to look at the impact of the feedback.
Geisner and Larimer said the idea of brief intervention treatment for depression needs more refinement and study but is promising, particularly because of its low cost. They estimate it cost less than $2 per person to deliver the treatment in this study. Other low-cost strategies that could be tested include weekly boosters delivered by e-mail and an Internet version of the treatment.
"The beauty of this study is that these people were not seeking help when they were sitting in a classroom, but help was brought to them," said Larimer. "People who received this brief intervention felt less hopeless and depressed, both physically and emotionally. Depression is a very costly problem and we should not wait for people to develop a more serious form of it before treatment is available."
Clayton Neighbors, a UW assistant professor of psychiatry and behavior sciences, was a co-author of the study funded by the National Institute on Alcohol Abuse and Alcoholism and the Stanley Foundation.
For more information, contact Geisner at (206) 419-8999 or geisner@u.washington.edu or Larimer at (206) 543-3513 or larimer@u.washington.edu
______________________________________
July 6, 2006
High Tylenol Doses Linked to Liver Woes
CHICAGO - Healthy adults taking maximum doses of Tylenol for two weeks had abnormal liver test results in a small study, researchers found, raising concerns that even recommended amounts of the popular painkiller might lead to liver damage.
In the study, 106 participants took four grams of Tylenol - equivalent to eight extra-strength Tylenol tablets - each day for two weeks. Some took Tylenol alone and some took it with an opioid painkiller. Dummy pills were given to 39 others.
There were no alarming liver test results among the people who took the placebos. But nearly 40 percent of people in all the other groups had abnormal test results that would signal liver damage, according to the study that appears in Wednesday's Journal of the American Medical Association.
"I would urge the public not to exceed four grams a day. This is a drug that has a rather narrow safety window," said a study co-author, Dr. Neil Kaplowitz of the University of Southern California.
Heavy drinkers should take no more than two grams daily, Kaplowitz said.
Another co-author, Dr. Paul Watkins of the University of North Carolina, said he's less worried than Kaplowitz, noting that acetaminophen, the active ingredient in Tylenol, has been used for 50 years and has a good safety record.
The maker of Tylenol, McNeil Consumer & Specialty Pharmaceuticals, said its own research found much lower rates of abnormal liver results. The company's studies tracked high-dose users over longer periods than did the new study.
"It doesn't lead to liver disease and it usually resolves as patients continue to take acetaminophen," said Dr. Edwin Kuffner, senior director of medical affairs at McNeil.
The researchers had been hired by the drug company Purdue Pharma LP, maker of the prescription painkiller OxyContin, to find out why abnormal liver tests were showing up in people testing a combination drug containing the acetaminophen and the opiate hydrocodone.
Purdue Pharma stopped its hydrocodone study early because of the abnormal liver tests. Researchers Watkins and Kaplowitz thought they would find the culprit in hydrocodone's interaction with acetaminophen.
"Our jaws dropped when we got the data," Watkins said. "It doesn't have anything to do with the opiate. It's good ol', garden-variety acetaminophen."
Acetaminophen is more popular than aspirin or ibuprofen. Each week, one in five U.S. adults uses it for pain or fever, a 2002 survey found.
Acetaminophen is included in numerous over-the-counter and prescription medications, making overdose possible as people unwittingly combine drugs. Overdoses of acetaminophen are the leading cause of acute liver failure.
"A week doesn't go by when I don't have to talk to someone about how much they're taking," said Kathleen Besinque of the USC School of Pharmacy.
Watkins said people considering switching painkillers should know that others have their own side effects, such as internal bleeding and stomach irritation.
New research under way at the University of North Carolina may determine if acetaminophen's effect on the liver continues for long-term, high-dose users, or if the body adapts, Watkins said.
JAMA: http://jama.ama-assn.org ____________________________________
July 4, 2006
Relation between age and cardiovascular disease in men and women with diabetes compared with non-diabetic people
Adults with diabetes are thought to have a high risk of cardiovascular disease (CVD), irrespective of their age. The main aim of this study was to find out the age at which people with diabetes develop a high risk of CVD, as defined by: an event rate equivalent to a 10-year risk of 20% or more; or an event rate equivalent to that associated with previous myocardial infarction.
The transition to a high-risk category occurred at a younger age for men and women with diabetes than for those without diabetes (mean difference 14·6 years). For the outcome of acute myocardial infarction (AMI), stroke, or death from any cause, diabetic men and women entered the high-risk category at ages 47·9 and 54·3 years respectively. When we used a broader definition of CVD that also included coronary or carotid revascularisation, the ages were 41·3 and 47·7 years for men and women with diabetes respectively.
Diabetes confers an equivalent risk to ageing 15 years. However, in general, younger people with diabetes (age 40 or younger) do not seem to be at high risk of CVD. Age should be taken into account in targeting of risk reduction in people with diabetes.
The Lancet 2006; 368:29-36 ____________________________________
|