July 5th, 2015

What’s the Safest Way to Administer Testosterone?

What’s the Safest Way to Administer Testosterone?

July 2, 2015

TRAVEL AT YOUR OWN RISK ****   Please understand that this study has nothing to do with the  ** FDA Issues Testosterone Warning**.  It just outlines which product may want to choose to get your STROKE or HEART ATTACK... This hormone is only needed in a very limited amount of problems.  Other words don't TRAVEL THIS ROUTE. (Armon B. Neel, Pharm.D. opinion)

Testosterone injections were associated with increased cardiovascular events, stroke, and mortality compared with topical deliver options, according to recent research.

The study assessed rates of myocardial infarction (MI), unstable angina, stroke, all-cause hospitalization, mortality, and venous thromboembolism (VTE) in a little more than 500,000 men who began testosterone therapy after a 180-day washout period: 37.4% used injections, 55.8% applied gel, and 6.9% stuck on patches. Of the men who received injections, 83% were on cypionate, 9.2% on enanthate, and 1.3% on propionate.

There were consistent increases in the risk of cardiovascular and cerebrovascular events, hospitalization, and death among men receiving injections compared with those receiving gels, according to study lead author Dr. J. Bradley Layton, a research assistant professor of epidemiology at the University of North Carolina Gillings School of Global Public Health.

In a comparison of patches and gels, said Dr. Layton, there was a slight increase in MI among patch wearers, but all other outcomes were inconsistent. “We did not observe any dosage form carrying a higher risk of VTE than the others,” he added.

More men are opting for testosterone therapy against current recommended guidelines despite a lack of conclusive findings on the therapy’s overall cardiovascular safety, according to the study. Dr. Layton said reports of adverse events have some experts questioning the increasing use of testosterone, especially in men with primary and age-related hypogonadism, with normal testosterone levels, or without recent baseline testing. “It’s important to understand the potential hazards of treatment,” he commented.

A few studies have suggested potential increases in cardiovascular risk with testosterone supplementation, but most looked at testosterone as a class, according to Dr. Layton, who said testosterone’s various dosage forms have difference pharmacokinetics.

According to the study, intramuscular injections create spikes in serum testosterone levels that gradually decrease until the next injection, whereas the daily application of gels and patches increases levels slightly over one to two days and maintains more consistent levels. Short-term jumps in testosterone levels can increase clotting risk and raise levels of red blood cells, so understanding the safety profiles of the different delivery options is critical, noted the researchers.

“We wanted to investigate if injection-related spikes were associated with a different cardiovascular safety profile than the other forms,” said Dr. Layton. He said there has been considerable interest in testosterone products, especially from regulatory agencies, as testosterone use has increased steadily over the past decade and some studies have suggested it’s associated with increased risks of adverse events.

The medical necessity of testosterone treatment should be carefully considered in men initiating the therapy, suggested Dr. Layton, who said the U.S. Food and Drug Administration recently clarified that the hormone is indicated only for men with specific disorders, not in those with natural, age-related declines in testosterone levels.

“Any potential benefit of treatment should be weighed against cardiovascular risks, particularly among injection users,” Dr. Layton added.

The study was published online in JAMA Internal Medicine.

Reference:

1. Layton JB, Meier CR, Sharpless JL, Sturmer T, Jick SS, Brookhart MA. Comparative safety of testosterone dosage forms. JAMA Intern Med. 2015 May 11. [Epub ahead of print]