Cardiovascular Safety of Testosterone-Replacement Therapy

Area of Science:

• Endocrinology
• Cardiovascular Medicine
• Clinical Trials

Background:

• Cardiovascular safety of testosterone-replacement therapy (TRT) in hypogonadal men is not well-established.
• Hypogonadism affects middle-aged and older men, often with pre-existing cardiovascular conditions.

Purpose of the Study:

• To determine the cardiovascular safety of TRT in men aged 45-80 with hypogonadism and cardiovascular disease or risk.
• To assess if TRT is noninferior to placebo in preventing major adverse cardiac events.

Main Methods:

• Multicenter, randomized, double-blind, placebo-controlled, noninferiority trial (TRAVERSE).
• 5246 men with hypogonadism and cardiovascular disease/risk received daily transdermal testosterone gel or placebo.
• Primary endpoint: composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.

Main Results:

• Testosterone therapy was noninferior to placebo (HR 0.96; 95% CI 0.78-1.17).
• No significant difference in primary composite cardiovascular events between groups (7.0% vs 7.3%).
• Higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

Conclusions:

• Testosterone-replacement therapy is noninferior to placebo for major adverse cardiac events in hypogonadal men with cardiovascular disease.
• While primary safety endpoints were met, increased risks of other adverse events warrant consideration.