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The New England Journal of MedicineCardiovascular Safety of Testosterone-Replacement Therapy

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.

Key Points:

  • 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).

Additional Points:

  • 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.

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