EDUCATION CENTER

Does TRT Increase the Risk of Heart Attack?

What TRAVERSE and labeling actually say.

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Does TRT increase the risk of heart attack?

The best modern randomized evidence, TRAVERSE (2023), showed that testosterone gel was noninferior to placebo for major adverse cardiac events in men with hypogonadism and established cardiovascular disease or high risk, over a median of about 22 months of treatment (longer follow-up for the primary endpoint as designed).

That does not mean TRT is a heart drug, or that every formulation and every dose is identical, or that men with uncontrolled heart failure or a very recent event are automatic candidates. Older observational scares and older FDA communications are why this question still comes up — bring it to your clinician with your history in hand.

What should you do with this information?

Treat heart-risk factors (blood pressure, lipids, diabetes, smoking, sleep apnea) whether or not you start TRT. Report chest pain or unexplained dyspnea immediately. Do not start testosterone to “protect the heart.”

FAQs

Did TRAVERSE prove TRT is cardioprotective?

No. Noninferiority versus placebo for MACE is not the same as benefit. It mainly reduced a specific safety uncertainty for gel in that population.

References

  1. 1. Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744.

  2. 2. Mulhall JP, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018;200(2):423-432.

  3. 3. Lincoff AM, et al. Cardiovascular Safety of Testosterone-Replacement Therapy (TRAVERSE). N Engl J Med. 2023;389:107-117.

  4. 4. U.S. Food and Drug Administration. Testosterone Information.

  5. 5. Bhasin S, et al. Testosterone Replacement in Aging Men: An Endocrine Society Scientific Statement. J Clin Endocrinol Metab.

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