Large-scale studies of testosterone therapy risks needed

Large-scale randomized, controlled trials are needed to determine the true risks and benefits of testosterone therapy in older men, the Endocrine Society said.

According to a statement issued by the Endocrine Society, the risks and benefits of testosterone therapy in older men with declining levels of the hormone need to be fully evaluated. The statement comes in response to recent studies that have raised concerns about the safety of testosterone therapy in older men with a history of heart disease.

The FDA has announced plans to evaluate the safety of testosterone therapy.

Two retrospective analyses and one randomized trial supported by the Veterans Health Care System and the National Institutes of Health found a higher rate of cardiovascular events in men who received testosterone and had preexisting heart problems.

Important safety data are expected from the National Institute on Aging’s ongoing randomized trial examining testosterone in about 800 older men with unequivocally low testosterone levels and accompanying symptoms, including sexual and physical dysfunction, the Endocrine Society said. The trial’s structure and careful monitoring of cardiovascular events will help provide important safety information.

“The Society calls for the development of more large-scale randomized controlled trials to determine the true risks and benefits of testosterone therapy in older men,” the Society said in a news release.

In the statement, the Society recommends that middle-aged and older men who are considering testosterone supplementation for age-related declines should be informed of the potential cardiovascular risks. The Society also believes that it may be prudent not to administer testosterone therapy to men who have had a cardiovascular event in the preceding 6 months.

“In cases where men are being treated for hypogonadism as a result of known diseases of the testes, pituitary, and hypothalamus, however, patients should consult their health care providers before making any changes to their medication regimen,” the release stated. “The Society believes testosterone is generally safe and beneficial when used to treat young, hypogonadal men with these conditions.”

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