Could testosterone-replacement therapy be a viable treatment option for middle-aged and older men with hypogonadism without exacerbating their cardiovascular risk?
In a critical examination of the cardiovascular safety of testosterone-replacement therapy in middle-aged and older men with hypogonadism, a multicenter trial has produced intriguing results.
- A multicenter, randomized, double-blind, placebo-controlled, noninferiority trial was conducted on 5,246 men aged 45-80 with hypogonadism and high cardiovascular disease risk.
- Participants received daily transdermal 1.62% testosterone gel (adjusted to maintain testosterone levels between 350 and 750 ng/deciliter) or placebo gel.
- The primary cardiovascular safety endpoint included first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
- A primary cardiovascular endpoint event occurred in 7.0% of the testosterone group and 7.3% in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.78 to 1.17; P<0.001 for noninferiority).
- Secondary cardiovascular end point also considered coronary revascularization.
- The mean duration of treatment was 21.7±14.1 months, with mean follow-up of 33.0±12.1 months.
- The incidence of secondary endpoint events was similar in both groups.
- A higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism was observed in the testosterone group.
- In men with hypogonadism and a high risk of cardiovascular disease, testosterone-replacement therapy did not show increased incidence of major adverse cardiac events compared to placebo.
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Did You Know?
Low testosterone levels, also known as hypogonadism, affect about 40% of men aged 45 and older.