Link Between Testosterone Drugs and Heart Risks Not Found in New Study

Following years of concerns that side effects of testosterone replacement therapy carry serious heart risks, the findings of new study suggests that men with hypogonadism did not experience any greater incidence of major adverse cardiovascular events when taking the drugs.

In findings presented in a study published this week in The New England Journal of Medicine, researchers with the Cleveland Clinic indicate they were unable to find any difference in heart problems among men given testosterone and those given a placebo.

Treatments for low testosterone were initially intended as a “niche” treatment, for men who experienced drops in testosterone levels associated with a condition known as hypogonadism. However, amid aggressive drug marketing in prior decades, which encouraged men to talk to their doctors about a non-existing medical condition referred to as “low T”, many men sought the treatments when they were not medically needed, to treat symptoms associated with natural drops in testosterone associated with aging.

Following the publication of a number of studies over the past decade that suggested use of the drugs increase the risk of blood clots, heart attacks, strokes and other injuries, the drug makers faced a number of testosterone lawsuits alleging that the medications were over-promoted and failed to contain adequate warnings. In addition, there has been substantial effort in the medical community to curb testosterone prescriptions to men with a true medical need, as opposed to those who previously received the medications for “life-style” reasons, to help increase energy levels, strength and sex drive.

In this new study, researchers conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial to better understand the cardiovascular safety of testosterone replacement therapy among middle-aged and older men. The study included 5,246 men between the ages of 45 and 80, who had preexisting cardiovascular disease or a high risk of the condition, and reported symptoms of hypogonadism.

Researchers tested the men to confirm their testosterone levels were low, and participants were given either a daily transdermal testosterone gel patch, or a placebo, to evaluate the occurrence of adverse heart problems.

According to the findings, after a mean duration of just under two years of testosterone use and an average of 33 months of follow-up, researchers found that adverse heart problems occurred in 7.3% of the patients given testosterone, and in 7.0% of men given a placebo. Researchers considered the results statistically insignificant. However, the researchers did note that there was a higher incidence rate of atrial fibrillation, acute kidney injury, and pulmonary embolism among the testosterone group.

“In men with hypogonadism and preexisting or a high risk of cardiovascular disease, testosterone-replacement therapy was noninferior to a placebo with respect to the incidence of major adverse cardiac events,” the researchers concluded.

Testosterone Health Concerns

From 2001 to 2013, prescriptions for testosterone drugs increased more than 300%. However, following studies that highlighted the potential risk of heart attacks, strokes and blood clots associated with testosterone therapy, the U.S. Food and Drug Administration (FDA) issued warnings about their overuse, and prescriptions have dropped in recent years.

Following continuing concerns about the side effects of testosterone treatments, the FDA ordered a label change for all prescription “Low T” drugs, such as AndroGel, Axiron, Testim, Depo-Testosterone and other gels, creams patches and injections after concluding there is evidence of a possible link between testosterone drugs and heart problems.

Over the last decade, thousands of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other claims have been settled by manufacturers of testosterone therapy, resolving allegations that the drugs were recklessly marketed and consumers were not adequately warned about the potential heart risks. Testosterone settlements have been reached to resolve nearly all pending claims in the U.S.