ENDO: Testosterone-Replacement Noninferior to Placebo for Cardiovascular Events

THURSDAY, June 22, 2023 (HealthDay News) -- For men with preexisting cardiovascular disease or a high risk for cardiovascular disease and hypogonadism, testosterone-replacement therapy is noninferior to placebo for the incidence of major adverse cardiac events, according to a study published online June 16 in the New England Journal of Medicine to coincide with the annual meeting of the Endocrine Society, held from June 15 to 18 in Chicago.

A. Michael Lincoff, M.D., from the Cleveland Clinic, and colleagues conducted a multicenter, randomized trial involving 5,246 men aged 45 to 80 years with preexisting cardiovascular disease or a high risk for cardiovascular disease, reported symptoms of hypogonadism, and two fasting testosterone levels of <300 ng/dL. Participants were randomly assigned to receive daily transdermal 1.62 percent testosterone gel or placebo gel.

The researchers found that a primary cardiovascular end point event (first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, assessed in a time-to-event analysis) occurred in 7.0 and 7.3 percent of patients in the testosterone and placebo groups, respectively (hazard ratio, 0.96; 95 percent confidence interval, 0.78 to 1.17). In sensitivity analyses in which data on events were censored at various times after discontinuation of testosterone or placebo, the findings were similar. The two groups had a similar incidence of secondary end point events or of each of the events of the composite primary cardiovascular end point.

"Our findings regarding the cardiovascular safety of testosterone may facilitate a more informed consideration of the potential benefits and risks of testosterone therapy among middle-aged and older men with hypogonadism," the authors write.

The study was funded by AbbVie, Acerus Pharmaceuticals, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Several authors disclosed financial ties to industry.

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