Endocrine Society Calls for Longer, Larger Studies on Testosterone

February 10, 2014

Hard on the heels of the decision of the Food and Drug Administration (FDA) to evaluate the safety of testosterone therapy, the US Endocrine Society is calling for a fuller assessment of the risks and benefits of testosterone treatment in older men with declining levels of the hormone.

The 2 decisions come in the wake of new studies that have raised concerns about testosterone therapy in older men with a history of cardiovascular disease. The most recent one shows that men treated with testosterone were significantly more likely to have a myocardial infarction (MI) in the first 90 days after starting the medication. The second study, of Veterans Affairs (VA) patients, published last year, also found that testosterone therapy in older men was linked with an increased risk for death, MI, or ischemic stroke.

In addition, in 2010, a randomized placebo-controlled trial of testosterone in older men with mobility limitation, funded by the National Institute on Aging (NIA), was stopped early by the trial's data and safety monitoring board, because of the higher frequency of cardiovascular-related events in those assigned to the testosterone arm of the trial compared with those in the placebo arm.

"These studies have heightened concern about the safety of testosterone therapy in older men with preexisting heart disease," the Endorine Society states.

Testosterone is approved for the treatment of hypogonadism due to known diseases of the testes, pituitary, and hypothalamus. And although the use of testosterone therapy is increasing, the therapy has not been approved for the treatment of age-related symptoms or the age-related decline of testosterone levels, the Endocrine Society stresses.

It notes that important data are expected from the National Institute of Aging's ongoing randomized Testosterone Trials examining testosterone in about 800 older men with unequivocally low testosterone levels and accompanying symptoms, including sexual and physical dysfunction.

"The trial's structure and careful monitoring of cardiovascular events will help provide important safety information," it states. But the society is also calling for the development of more large-scale randomized controlled trials to determine the true risks and benefits of testosterone therapy in older men.

Older Men With CV History Should Not Take Testosterone

In the meantime, "physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have preexisting heart disease," the society notes.

Doctors should prescribe testosterone "in accordance with the society's clinical-practice guidelines on testosterone therapy in men with hypogonadism. Testosterone therapy should be accompanied by a standardized monitoring plan to optimize the dose and minimize the risk of adverse effects."

Middle-aged and older men who are considering testosterone supplementation for age-related declines should be informed of the potential cardiovascular risks, it states. And it may be prudent "not to administer testosterone therapy to men who have had a cardiovascular event (such as myocardial infarction, stroke, or acute coronary syndrome) in the preceding 6 months."

However, in cases where men are being treated for hypogonadism as a result of known diseases of the testes, pituitary, and hypothalamus, patients should consult their healthcare providers before making any changes to their medication regimen, the society stresses.

"The society believes testosterone is generally safe and beneficial when used to treat young, hypogonadal men with these conditions." The society's clinical-practice guideline on testosterone therapy in this population is available here.


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