Cardiovascular Safety of Testosterone-Replacement Therapy

This multicenter, randomized, double blind, placebo controlled trial evaluated the cardiovascular safety of testosterone replacement therapy in 5,246 men aged 45 to 80 with hypogonadism and preexisting or high risk of cardiovascular disease. Participants received daily transdermal testosterone gel or placebo, with doses adjusted to maintain testosterone levels between 350 and 750 ng per deciliter. The primary endpoint was the first occurrence of major adverse cardiac events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). Results showed no significant difference in the incidence of primary endpoint events between the testosterone (7.0%) and placebo (7.3%) groups (hazard ratio, 0.96; 95% CI, 0.78 to 1.17; P<0.001 for noninferiority). However, the testosterone group had higher incidences of atrial fibrillation, acute kidney injury, and pulmonary embolism. The study concluded that testosterone replacement therapy was noninferior to placebo regarding cardiovascular safety in this population.

This multicenter, randomized, double blind, placebo controlled trial evaluated the cardiovascular safety of testosterone replacement therapy in 5,246 men aged 45 to 80 with hypogonadism and preexisting or high risk of cardiovascular disease. Participants received daily transdermal testosterone gel or placebo, with doses adjusted to maintain testosterone levels between 350 and 750 ng per deciliter. The primary endpoint was the first occurrence of major adverse cardiac events (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). Results showed no significant difference in the incidence of primary endpoint events between the testosterone (7.0%) and placebo (7.3%) groups (hazard ratio, 0.96; 95% CI, 0.78 to 1.17; P<0.001 for noninferiority). However, the testosterone group had higher incidences of atrial fibrillation, acute kidney injury, and pulmonary embolism. The study concluded that testosterone replacement therapy was noninferior to placebo regarding cardiovascular safety in this population.