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Another Study Suggests Excess Cardiovascular Risk with Testosterone

February 4, 2014

Another Study Suggests Excess Cardiovascular Risk with Testosterone

  1. Allan S. Brett, MD

The FDA has announced that it is reassessing the safety of testosterone products.

  1. Allan S. Brett, MD

In a recent observational U.S. study, testosterone therapy was associated with excess cardiovascular risk in older men with risk factors (NEJM JW Gen Med Nov 19 2013). In this new study, NIH-supported researchers examined the same issue, using a large database with information from employer-sponsored insurance plans.

Nearly 56,000 men received new prescriptions for testosterone. Their annualized rate of myocardial infarction (MI) during the 3 months after initiating testosterone therapy was significantly higher (by 36%) than the rate during the previous year. In contrast, MI rates were not significantly different before and after initiation of phosphodiesterase type 5 (PDE5) inhibitors (sildenafil and tadalafil [Cialis]) prescribed for erectile dysfunction.

Next, the testosterone and PDE5 cohorts were compared after extensive adjustment for baseline differences. In younger patients (age, <65) without MI histories, testosterone use (compared with PDE5 use) was not associated with excess MI risk. However, in younger patients with previous MIs, and in older patients (regardless of MI history), testosterone use was associated with roughly twice the risk for MI, compared with PDE5 use.

Comment

In this observational study, the incidence of myocardial infarction rose in at-risk subgroups within 3 months after initiating testosterone therapy; absolute risk was roughly 5 to 10 excess MIs per 1000 person-years. Because these results are consistent with findings from the aforementioned U.S. study and from a recently published meta-analysis (BMC Medicine 2013; 11:108), the FDA has announced that it is reassessing the safety of testosterone products. An NIH-sponsored 1-year randomized trial (the “T Trial”) with 800 participants is under way, but it might not be sufficiently powered to settle concerns about cardiovascular risk.

  • Disclosures for Allan S. Brett, MD at time of publication Nothing to disclose

Citation(s):

Reader Comments (4)

Dr. V Kantariya MD Physician, Family Medicine/General Practice

We need more rational approahes to the diagnosis and treatment of hypogonadism in older men. By administering a different testosterone replacement drugs, a variety of testosterone doses. It is difficult to treat without adverse effects. What to do? Medication Errors(wrong indication, no indication, incorrect dose, treatment duration)need to be considered.

BRUCE ALAN Other

Has it been considered that the greater and more frequent intensity of sex is responsible rather than the testosterone itself?

KOLLAR JOZEF Other Healthcare Professional, Cardiology, Kosice, Medical Faculty of University Šafarik

I have been applied one ampulla of testosterone every month five-times to adult men in 50-years old, for his sexual impotence. He has been asked testosterone by his wife.
Sexual appetite has been raised over expectation. He suddenly died for myocardial infarction six month after first ampulla.

NORA GARZA

What dose was your patient injecting? We're his levels within normal? Did he have other risk factors?

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