Testosterone elevating drugs free of heart attack risk, study says

Jacques Baillargeon

The back-and-forth on the health risks of men taking drugs to raise testosterone levels have clouded the benefits and risks for this rapidly growing category of meds and more fog has just rolled in. A new study of 24,000 Medicare patients found there is no heart attack risk associated with the drugs and they even provided some protection in men judged most likely to suffer one.

"Our investigation was motivated by a growing concern, in the U.S. and internationally, that testosterone therapy increases men's risk for cardiovascular disease, specifically heart attack and stroke," said Jacques Baillargeon, associate professor at University of Texas Medical Branch at Galveston, who led the study that was funded in part by the National Institutes of Health. "This concern has increased in the last few years based on the results of a clinical trial and two observational studies," he said in a statement. "It is important to note, however, that there is a large body of evidence that is consistent with our finding of no increased risk of heart attack associated with testosterone use."

The market for testosterone treatments that can boost sex drive and muscle tone in men has been growing rapidly, but many of these drugs are used off-label for that purpose. AbbVie ($ABBV) has the top-selling drug, AndroGel, but Eli Lilly ($LLY), Pfizer ($PFE) and others also have products in the market that reached about $1.6 billion last year and is projected to reach $5 billion by 2017.

The FDA has only approved drugs to be used to treat specific low testosterone conditions, such as depletion as a result of chemotherapy or deficiency from genetic problems. There have been some studies that suggested that men were putting themselves at greater risk for heart attacks or stroke by using the products, but some of that research has been attacked by other researchers. The FDA has been looking at the research and last month responded by saying the products needed a general warning about the risk of blood clots in veins to "ensure this risk is described consistently." EU regulators in April also said they were investigating their cardiovascular risks.

The UTMB study, published in the July 2 issue of Annals of Pharmacotherapy, looked at Medicare data for a "clinically and socioeconomically diverse national sample" from 1997-2005, then evaluated that in comparison with men of the same age, race, Medicaid eligibility and health status, who did not receive testosterone enhancing drugs. They were all 66 years or older. Not only did the team find no higher risk for those getting the testosterone drugs, it said the incidents of heart attack were actually lower among men considered at high risk for heart attack who took one of the testosterone drugs than for high risk men who did not.

"This is a rigorous analysis of a large number of patients," Baillargeon said in a statement. But he conceded that a large–scale, randomized clinical trials were needed to provide more definitive evidence.

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