Applying topical testosterone appears to raise the risk of cardiovascular events including myocardial infarction, atrial fibrillation, and stroke in older men with limited mobility, a study has found.
Compared with men who had lower levels of circulating testosterone, men with testosterone levels in the highest quartile more than doubled their risk of cardiovascular events, (HR 2.4; P=0.05), wrote Shalender Bhasin, MD, of Boston University, and colleagues in a study published online June 30 by the New England Journal of Medicine.
"Testosterone gel ... was associated with a greater frequency of adverse events, particularly cardiovascular, respiratory, and dermatologic events," the authors wrote. "The divergence between the [testosterone gel and placebo gel] groups in the incidence of cardiovascular adverse events was maintained over the six-month intervention period and did not diminish during the three-month observation phase that followed the intervention period."
The pattern of adverse cardiovascular events associated with testosterone therapy was considered by the data and safety monitoring board to be of sufficient concern to warrant termination of the trial before the target number of 252 patients had been enrolled.
Testosterone did, however, increase strength and improve mobility -- the primary endpoint of the trial. The men randomized to transdermal testosterone improved leg and chest press strength and improved stair-climbing power while carrying a load compared with controls.
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