For men with pre-existing CVD or a high risk for CVD and hypogonadism, testosterone replacement therapy is non inferior to placebo for the incidence of major adverse cardiac events, according to a study published in the New England Journal of Medicine to coincide with the annual meeting of the Endocrine Society. A. Michael Lincoff, MD, and colleagues assessed 5,246 men aged 45-80 with pre-existing CVD or a high risk for CVD, reported symptoms of hypogonadism, and two fasting testosterone levels of less than 300 ng/dL. Participants were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo. A primary cardiovascular endpoint event (first occurrence of any component of a composite of death from cardiovascular causes, nonfatal MI, or nonfatal stroke, assessed in a time-to-event analysis) occurred in 7.0% of patients in the testosterone group and 7.3% of patients in the placebo group (HR, 0.96; 95% CI, 0.78-1.17). In sensitivity analyses, the findings were similar. The two groups had a similar incidence of secondary endpoint events or each of the events in the composite primary endpoint.
