Studies demonstrate testosterone’s CV safety, benefits
Two recently published studies significantly contribute to current knowledge regarding testosterone therapy and cardiovascular health, says one expert urologist.
Researchers led by Shalender Bhasin, MD, of Brigham and Women’s Hospital, Boston and co-authors reported that 3 years of testosterone replacement therapy (TRT) in older men with low or low-normal testosterone does not cause progression of subclinical atherosclerosis. The prospective, double-blind, placebo-controlled clinical trial was published in JAMA (2015; 314:570-81).
In addition, as reported online in a fast-track article in the European Heart Journal (Aug. 6, 2015), findings of a large observational study designed specifically to examine the effect of normalization of TRT on cardiovascular outcomes in men with low testosterone showed it significantly reduced risks of all-cause mortality, myocardial infarction, and stroke.
The findings of both studies add another chapter to the ongoing discussion of TRT safety, cardiovascular safety in particular. In March 2015, the FDA issued a statement requiring makers of approved products to include revised labels indicating a possible risk of MI and stroke associated with the products. The FDA is also requiring manufacturers of the agents to conduct a controlled clinical trial to better determine the effects of TRT on cardiovascular outcomes.
In a recent development, FDA officials are now urging drug makers to collaborate on a single study. “We are encouraging companies to work together on a single trial,” Christine P. Nguyen, MD, and colleagues at the FDA wrote in the New England Journal of Medicine (2015; 373:689-91). “We believe the health of American men will be well served by the presence of accurate drug labels and reliable data to inform clinical decision making.”
The JAMA study (Testosterone’s Effects on Atherosclerosis Progression in Aging Men [TEAAM]) was conducted at three centers and included 308 men who were at least 60 years of age (mean 67.6 years) and had a total morning testosterone of 100 to 400 ng/dL. Fifteen percent of the cohort had cardiovascular disease, and many men had cardiovascular disease risk factors (hypertension, 42%; diabetes, 15%; obesity, 27%). Participants were randomized 1:1 to daily treatment with 7.5 grams of 1% testosterone or placebo gel; dose adjustments were made to achieve a testosterone level of 500 to 900 ng/dL.
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