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Dr. Lincoff discusses background of TRAVERSE study of testosterone replacement therapy


A. Michael Lincoff, MD, shares the impetus for the TRAVERSE study.

In this video, A. Michael Lincoff, MD, shares the background behind 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.


Please describe the background for this study.

The FDA initiated a review of the use of testosterone replacement therapy in middle-aged and older men in 2010. A small trial of testosterone in older men, the TOM trial, was stopped early by the data safety monitoring committee because of what appeared to be an excess risk of cardiovascular events among the men who had received testosterone. This was a very small trial, with only about 200 men. But the cardiovascular events occurred in 23 patients in the testosterone arm and 5 patients in the placebo arm, so it's a fairly high hazard ratio. The issue is that, although the indication of the approval of testosterone was primarily for severe hypogonadism associated with Klinefelter's or similar genetic disorders or chemical or physical castration, the predominant use in the United States by far is in middle-aged and older men with symptoms of hypogonadism. And those are the same men who have a very high prevalence of cardiovascular disease—as much as 60%—or at least cardiovascular risk factors. And so this finding from the TOM trial was of concern. They reviewed a meta analysis of all the different randomized trials, which also suggested an increased risk, although the number of events that would have qualified as severe major adverse cardiac events was relatively low. And then they also looked at retrospective studies, which had very mixed results and of course are confounded. So I was privileged to be part of an advisory committee meeting that they held in September of 2014, the question to which was, is there sufficient information to make a decision one way or the other? And the overriding consensus was there was not. And so the FDA issued a guidance in March of 2015 that changed the labels, putting a warning on the label of testosterone products and also required testosterone manufacturers to conduct a trial or trials of sufficient size and appropriate design to rule out whether there was an increased risk of myocardial infarction stroke, with testosterone replacement therapy in that group. That was the motivation for the TRAVERSE trial.

This transcript was edited for clarity.

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