Cardiovascular Safety of Testosterone-Replacement Therapy

13 Jul 2023 • There has been longstanding concern that testosterone replacement therapy may increase cardiovascular risk, as well as the risk of thromboembolic disease. The TRAVERSE trial was performed as a response to the Food and Drug Administration’s requirement in 2015 that manufacturers of testosterone replacement therapy conduct such trials.

The results are very reassuring in that testosterone replacement does not increase overall cardiovascular risk in this group of patients with symptomatic hypogonadism and low testosterone level. This study does not address testosterone’s safety in otherwise normal people who take it solely to build muscle or for other reasons—it just applies to patients with symptomatic hypogonadism and low testosterone levels.


  • The primary endpoint(occurrence of nonfatal stroke, death from cardiovascular cause, nonfatal myocardial infarction, or nonfatal stroke) occurred in 7% of the testosterone group and in 7.3% of the placebo group.
  • Of note, a higher incidence of pulmonary embolism, acute kidney injury, and atrial fibrillation was noted in the testosterone group
  • With this, it may be prudent to avoid usage of testosterone replacement in men with prior thromboembolic events, and perhaps even with those with paroxysmal atrial fibrillation or prior renal insufficiency.

In summary, testosterone therapy appears generally safe from an overall cardiovascular standpoint but may come with risks that must be weighed in balance with its potential benefits on an individual patient whose hypogonadism may be affecting their overall quality of life.

Source: American College of Cardiology | Read full story

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