Concerns Raised About Testosterone Therapy

Radar screen with red heart.

Increasing numbers of men are being treated with testosterone replacement therapy. Many cardiologists have been concerned about the potential for adverse cardiovascular effects of testosterone replacement therapy.

So the major new study published in the Journal of American Medical Association that links testosterone replacement therapy to increased risks of heart attack, stroke or death in older men isn’t necessarily surprising.

But it does raise greater concerns about testosterone therapy.

The aggressive marketing and prescribing of these testosterone gels, patches and injections — often targeted to older guys who want to feel young again — isn’t supported with nearly enough data on their long-term effects.

The U.S. Food and Drug Administration says it plans a review of these therapies to investigate the risk of stroke, heart attack and death in men taking FDA-approved testosterone products.

Greater risk of heart attack, stroke or death

The study looked at 8,709 men, average age early 60s, with low testosterone levels. Most had heart disease. After undergoing coronary angiography, one in seven men subsequently received testosterone replacement therapy.

Three years after the men’s initial heart tests, researchers found the number of patients experiencing heart problems like heart attack and stroke was 20 percent for those not on testosterone — and almost 26 percent for those who were.

After taking into account the patients’ initial heart test findings, researchers calculated that for these men using testosterone was tied to a 29 percent greater risk of heart attack, stroke or death.

More caution with testosterone therapy

This is an observational study and doesn’t prove testosterone therapy is unsafe. But it strongly signals more caution in both using and prescribing the treatment. A few things to think about:

  • If you’re thinking of testosterone replacement as a boost, consider your age and general health overall. If you’re young, healthy, have sufficient testosterone level already but think it’d be a great boost, remember: it’s an anabolic steroid. All steroid use comes with risks.
  • If you’re using testosterone already, ask yourself, what is this doing for me? Is it making me feel better? What exactly are the benefits I’m experiencing? Be sure to talk with your doctor about this if it’s been prescribed to you.
  • If you’re older and have heart or other health issues, be sure to talk over the potential benefits and risks with your doctor very carefully.

Testosterone replacement therapy may indeed be indicated for some men, but this therapy needs more long-term safety trials to clarify benefits and risks.

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Steven Nissen, MD

Steven Nissen, MD, is Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic. In 2007, TIME Magazine named him “one of the 100 most influential people in the world.”