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Controversy over Cardiovascular Risks of Testosterone Therapy.

In 2013 and 2014, several studies got widespread attention for their findings that men receiving testosterone therapy were at increased risk for cardiovascular complications, including myocardial infarction, stroke, and death. Because of the media coverage generated by these studies, some physicians stopped prescribing testosterone, and the U.S. Food and Drug Administration (FDA) announced plans to review the cardiovascular safety issues. In March of this year, the FDA issued an alert saying, in part, that health care professionals should make patients aware of the possible elevated cardiovascular risk associated with starting or continuing testosterone therapy. The FDA also required manufacturers to clarify the approved uses of testosterone therapy in their labeling. In February, however, a team of researchers published a review in Mayo Clinic Proceedings of the available literature on the cardiovascular risk associated with testosterone therapy and specifically singled out the 2013 and 2014 studies (by Vigen and colleagues and Finkle and colleagues, respectively) that had sparked the media storm and changes in prescribing practices, noting serious flaws in data collection and analysis, as well as two others, which they believe do not prove an elevated risk. Morgentaler and colleagues, who had submitted their data to the FDA for review during the agency’s public commentary period, note (as does an accompanying editorial) that there has been a widespread international call for the retraction of the study by Vigen and colleagues, who used unvalidated methodology to interpret the study’s findings and misrepresented the study population, among other mistakes. When that study’s data are appropriately interpreted, the authors write, they in fact demonstrate a lower percentage of adverse cardiovascular events in the men who received testosterone therapy than in the group that was untreated. Morgentaler and colleagues point out that testosterone deficiency has significant negative health effects in men, including increased risks of death, atherosclerosis, and incident coronary artery disease, as well as the worsening of cardiovascular risk factors such as obesity, increased fat mass, and insulin resistance. In fact, two decades of evidence suggest that testosterone therapy actually has a demonstrated history of alleviating this damage. The authors conclude that, although no definitive statement can be made about the absolute safety or risk of testosterone therapy, there is no conclusive evidence that it increases cardiovascular risk, and there is strong evidence that higher levels of testosterone ameliorate that risk. The FDA, in contrast, seems unconvinced.—David Carter