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UGA Pharmacy Magazine - Fall 2007

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February 20, 2008

FDA Issues alert on musculoskeletal pain associated with Bisphosphonates

The FDA recently issued a warning regarding the potential for incapacitating bone, joint, and/or muscle pain following bisphosphonate use. Risk factors for developing this pain are unknown and the pain may develop within days, months, or even years after initiating therapy. Symptoms may resolve completely after discontinuing therapy or may resolve more slowly for some patients. This side effect is in contrast to the acute phase response that includes fever, chills, myalgia, arthralgias, and bone pain. The acute phase reaction occurs with administration of IV bisphosphonates or initial exposure to oral regimens. The FDA is encouraging healthcare professionals to consider bisphosphonates as a potential cause in patients reporting musculoskeletal pain. Physicians and pharmacists should consider temporarily or permanently discontinuing the bisphosphonate in these patients,

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February 13, 2008

Discovery sparks hope for Parkinson's treatment

The possibility of a new treatment for Parkinson's disease has emerged, according to U.S. researchers claiming a key finding.

They said they recently discovered a glitch in cell function that can lead to the disease. In healthy cells, damaged proteins are digested and recycled in a process called autophagy. Researchers "have found in Parkinson's there are problems in removing abnormal proteins," according to Ana Maria Cuervo, cell biologist at the Albert Einstein College of Medicine of Yeshiva University.

Cuervo and her team are hopeful that new drugs to aid in the process of cleaning up abnormal proteins in cells will be available in five years time, though they say these drugs will not be a cure for the disease.
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February 7, 2008

Seniors have more post-operative memory problems, study shows


Individuals over 60 are more than twice as likely to develop memory problems after non-cardiovascular surgery than their younger counterparts, according to new study results. In addition, elderly post-op patients whose memory problems persisted longer than three months were more likely to die within the 12-month period after surgery.

Doctors "have known that patients undergoing heart surgery are at risk for cognitive dysfunction ... but the effects of non-cardiac surgeries on brain function are not as well-understood," said Dr. Terri Monk, a Duke University Medical Center anesthesiologist who authored the report.

Surgery and anesthesia could cause swelling of the brain that affects memory and cognitive process, Monk explained. If seniors are shown to be predisposed to cognitive problems after surgery, doctors could devise better strategies to prevent after-effects of surgery and anesthesia on the brain, she noted.

Nearly 1,100 patients were given tests to determine levels of cognitive function before, immediately after and three months after surgery. About 1 in 8 (12.7%) in the 60-plus group had some form of memory defect, compared with only 5.6% in the younger groups.

Roughly 30% top 40% of all adult patients undergoing major non-cardiac surgery experience some form of memory or processing problem at the time of discharge, but most people recover within three months, experts say.
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February 5, 2008

Diabetes study halted after lowering blood glucose increased risk of death


The US National Institutes of Health (NIH) has stopped one treatment arm of a major study on diabetes and heart disease after a higher than expected number of deaths occured among patients receiving intensive therapy to lower their blood glucose levels.

The ACCORD study, which started enrolment in 2001, involves more than 10 000 patients with type 2 diabetes who have been diagnosed with or are at high risk for heart disease or stroke. In the intense treatment group, 257 patients died, compared with 203 in the standard treatment group, according to NIH's National Heart, Lung, and Blood Institute (NHLBI).

Participants in both the intensive and standard therapy groups received FDA-approved diabetes medications, including rosiglitazone, marketed by GlaxoSmithKline as Avandia, and other thiazolidinediones, as well as insulins, sulfonylureas, exenatide, metformin and acarbose. Most patients in the intensive therapy group received a combination of these drugs.

For the intensive therapy group, the goal was to lower blood glucose levels, as measured by haemoglobin A1C, to less than six percent, which is similar to that of adults without diabetes. The standard therapy group aimed for blood glucose levels of 7 percent to 7.9 percent, which is a common target for adults with diabetes. “A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes,” commented Elizabeth Nabel, director of the NHLBI.

Researchers have not determined a specific cause for the higher number of deaths in the intensive treatment group, but said there is no evidence that it is linked to a particular medication. The review included an analysis on the effects of Avandia, which was linked in a study published last May to a 43-percent higher risk of heart attack than placebo or other treatment options. “Because of the recent concerns with rosiglitazone (Avandia), our extensive analysis included a specific review to determine whether there was any link between this particular medication and the increased deaths. We found no link,” stated William Friedewald, chair of the study's steering committee.

GlaxoSmithKline commented that the study raises questions about how aggressively blood glucose should be reduced in patients with diabetes who are at high risk for heart disease. "These could be important findings if they can shed more light on how we improve the management of patients with diabetes," stated the company.
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