“For this population of patients…testosterone replacement therapy does appear to be safe from a cardiovascular standpoint,” says A. Michael Lincoff, MD.
In this video, A. Michael Lincoff, MD, the take-home message of the recent New England Journal of Medicine study, “Cardiovascular Safety of Testosterone-Replacement Therapy.” Lincoff is vice chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine and an interventional cardiologist in the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute at Cleveland Clinic in Cleveland, Ohio.
The take-home message is that in a population of patients that we studied, which means patients who are middle aged or older, who have symptoms of hypogonadism, and who have testosterone levels which are measured and are below 300 ng/dL, testosterone replacement therapy, given carefully with close monitoring of levels and to prevent polycythemia, is safe from the standpoint of major adverse cardiac events, that it does not increase the risk of major adverse cardiac events. Now, the treatment period was on average about 2 years, but then that kind of reflects clinical practice where many patients go off drugs. This is not a license for centers that are not doing this in a medically responsible fashion. That may sound judgmental, but I think it's real. In 1 survey that the FDA reported on during the advisory committee meeting, 25% to 30% of men who were getting testosterone had never had a testosterone level checked. And so this is not a theoretical concern. This is a real concern. [It's about] finding the right patients, monitoring them carefully, and recognizing who was studied in the trial. It also doesn't apply to people who have normal testosterone levels, it doesn't apply to people taking testosterone or testosterone-like androgenic steroids for muscle mass and for athletic training. It doesn't really apply to transgender use of testosterone because there may be a degree of dimorphism in terms of effects of testosterone. But for this population of patients, which is the predominant population getting it, testosterone replacement therapy does appear to be safe from a cardiovascular standpoint.
This transcript was edited for clarity.
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