"I can't speak for the FDA, but I would hope and anticipate that the results of this trial may lead to a modification of the label and the warning," says A. Michael Lincoff, MD.
In this video, A. Michael Lincoff, MD, discusses the potential impact 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.
How do these findings impact counseling for patients with hypogonadism and preexisting or high risk of cardiovascular disease?
I would think they would have a fairly substantial impact. Hypogonadism is not a fatal disease. The treatment effect of testosterone, even when successful, is modest. That's clearly been demonstrated in the T Trials...and is evidenced by the fact that 60% of patients came off drug during trial at some point, mostly voluntarily. The treatment decisions, I believe, were overshadowed by this question of whether there was cardiovascular risk in this FDA label. I can't speak for the FDA, but I would hope and anticipate that the results of this trial may lead to a modification of the label and the warning. And I think what it would allow people to do is focus less on am I markedly increasing my cardiovascular risk and more are on, am I the kind of patient who's likely to benefit, whose symptoms are likely related to hypogonadism and can focus more on the real risks and benefits that are related to the hypogonadism itself rather than this concern about, am I placing patients at increased cardiovascular risk?
This transcript was edited for clarity.