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New Study Shows Testosterone Replacement Does Not Increase Risk of Cardiovascular Events

New Study Shows Testosterone Replacement Does Not Increase Risk of Cardiovascular Events

As the medical community increasingly tries to understand the cardiovascular implications of testosterone-replacement therapy (TRT) in men with hypogonadism, the recently concluded TRAVERSE study brings enlightening insights. Published in the New England Journal of Medicine, this multicenter, randomized, double-blind, placebo-controlled trial enrolled 5246 men aged 45 to 80, shedding light on the cardiovascular safety of TRT in individuals with preexisting or high-risk cardiovascular conditions.


Study Overview:

The trial aimed to determine whether TRT poses a heightened risk of cardiovascular events in middle-aged and older men with hypogonadism. Patients with preexisting or elevated cardiovascular risk factors were enrolled, and they were randomly assigned to receive either daily transdermal 1.62% testosterone gel or a placebo gel. The primary cardiovascular safety endpoint was the occurrence of major adverse cardiac events, including death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.


Key Findings:

The study, spanning a mean duration of 22 months, reported intriguing results. The primary safety endpoint event incidence was comparable between the testosterone and placebo groups, with a hazard ratio of 0.96 (95% CI, 0.78 to 1.17), establishing noninferiority. Additional sensitivity analyses further supported the conclusion, providing a comprehensive evaluation of cardiovascular outcomes.

Moreover, the trial delved into secondary cardiovascular endpoints, revealing no substantial differences between the testosterone and placebo groups. However, a higher incidence of pulmonary embolism was noted in the testosterone group, emphasizing the need for cautious use in individuals with a history of thromboembolic events.


Adverse Events and Considerations:

The study meticulously examined adverse events associated with TRT. Notably, cases of prostate cancer were comparable between the testosterone and placebo groups, and the increase in PSA levels from baseline was greater in the testosterone recipients. A modest increase in blood pressure was observed in the testosterone group, aligning with previous observations.


Implications for Clinical Practice:

These findings carry significant implications for clinicians and individuals considering TRT. Amidst the uncertainty and past conflicting data, the TRAVERSE study provides valuable clarity, particularly for middle-aged and older men with hypogonadism and cardiovascular concerns.

Read Full Study


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