In the midst of controversy, four new studies have found no link between testosterone therapy and cardiovascular risk.
These results come at a time of great debate on the safety of testosterone replacement therapy. In March, the U.S. Food and Drug Administration (FDA) announced new labeling requirements that would clarify the approved uses of testosterone and point out the potential for cardiovascular risks. Some experts feel that these changes are not necessary.
Two of the studies were presented on March 7th at the annual meeting of the Endocrine Society, held in San Diego, California:
• Colleagues from Eli Lilly questioned whether there was a link between testosterone therapy and venous thrombotic events (blood clots). After comparing data from 102,650 men treated with testosterone and 102,650 untreated hypogonadal men, they concluded that there was no association.
• A research team from GlaxoSmithKline investigated darapladib in light of cardiovascular events. “TRT is not associated with an increased risk of [major adverse cardiovascular events] in men with well characterized coronary heart disease,” the authors wrote.
Two additional studies were presented at the American College of Cardiology Scientific Sessions held March 14-16, also in San Diego:
• Researchers from Aurora Health Care in Milwaukee, Wisconsin, presented their study of 7,245 men (average age 54 years) with low testosterone. They found that the combined rate of heart attack, stroke, or death was 5.5% for the men taking testosterone and 6.7% for those who did not.
• Scientists from Regions Hospital in St. Paul, Minnesota conducted a meta-analysis of 29 studies involving 122,889 men. They found that testosterone therapy “does not cause statistically significant cardiovascular events among men.”
While these four studies counter the FDA’s rationale for changes in testosterone product labeling, more research is still needed to definitively answer the cardiovascular risk question.
American College of Cardiology
Ali, Zuber, et al.
“Effects of testosterone supplement therapy in men with low testosterone”
(Abstract 1126M-13, presented at American College of Cardiology 2015 Scientific Sessions, March 14, 2015, San Diego, CA)
Patel Pawan, et al.
“Effect of testosterone therapy on adverse cardiovascular events among men: A meta-analysis”
(Abstract 1195-376, presented at American College of Cardiology 2015 Scientific Sessions, March 15, 2015, San Diego, CA)
The Endocrine Society
Janmohamed, Salimm BSc MBBS (Hons) FRCP, et al.
“The Association Between Testosterone Use and Major Adverse Cardiovascular Events (MACE): An Exploratory Retrospective Cohort Analysis of Two Large, Contemporary, Coronary Heart Disease Clinical Trials”
(Abstract OR34-4, presented at the Endocrine Society’s 97th Annual Meeting and Expo, March 7, 2015, San Diego, CA)
Li, Hu, MBBS, PhD, et al.
“Assessment of the Association Between the Use of Testosterone Replacement Therapy (TRT) and the Risk of Venous Thrombotic Events Among TRT-Treated and Untreated Hypogonadal Men”
(Abstract OR34-2, presented at the Endocrine Society’s 97th Annual Meeting and Expo, March 7, 2015, San Diego, CA)
“Two Studies Suggest Testosterone Might Not Increase Risks of Cardiovascular Events”
(March 9, 2015)
Tucker, Miriam E.
“More Studies Support Testosterone CV Safety, Debate Continues”
(March 16, 2015)