Cardiovascular Safety of Testosterone-Replacement Therapy

This randomized, double-blind, placebo-controlled trial (TRAVERSE) assessed cardiovascular safety of testosterone-replacement therapy in 5246 men (aged 45–80) with hypogonadism and elevated cardiovascular risk. Participants were assigned to transdermal testosterone gel or placebo for ~22 months. The primary outcome major adverse cardiac events (death from cardiovascular causes, nonfatal myocardial infarction or stroke) occurred in 7.0% of the testosterone group vs. 7.3% with placebo (HR 0.96; CI 0.78–1.17), confirming noninferiority. Secondary outcomes showed similar results. However, increased atrial fibrillation, pulmonary embolism, and acute kidney injury were noted in the testosterone group. Findings support cardiovascular safety of testosterone-replacement in high-risk populations, though caution is advised regarding certain adverse events.

This randomized, double-blind, placebo-controlled trial (TRAVERSE) assessed cardiovascular safety of testosterone-replacement therapy in 5246 men (aged 45–80) with hypogonadism and elevated cardiovascular risk. Participants were assigned to transdermal testosterone gel or placebo for ~22 months. The primary outcome major adverse cardiac events (death from cardiovascular causes, nonfatal myocardial infarction or stroke) occurred in 7.0% of the testosterone group vs. 7.3% with placebo (HR 0.96; CI 0.78–1.17), confirming noninferiority. Secondary outcomes showed similar results. However, increased atrial fibrillation, pulmonary embolism, and acute kidney injury were noted in the testosterone group. Findings support cardiovascular safety of testosterone-replacement in high-risk populations, though caution is advised regarding certain adverse events.