By Julie Steenhuysen

(Reuters Health) – Older men whose testosterone levels have dropped over the years should only be given testosterone replacement to treat sexual dysfunction, according to new guidelines from the American College of Physicians released on Monday.

Sales of treatments for low testosterone or “low T” tripled from 2001 to 2011, fueled by direct-to-consumer advertising promising that androgen replacement therapy – testosterone in the form of skin patches, topical gels, pills and shots – could restore men’s vitality and libido.

That trend reversed starting in 2013 as studies were published suggesting the treatments carried the risk of stroke and heart attack. In 2016, the U.S. Food and Drug Administration ordered manufacturers to list warnings of the risk for heart-related and mental health side effects on product labels.

But the drugs remain popular, driven by direct-to-consumer TV ads, said Dr. Robert McLean, president of the American College of Physicians (ACP).

“You can’t watch cable TV without seeing an ad saying, ‘Hey, check your T.’ We all know this is marketing testosterone replacement as kind of the fountain of youth,” McLean said in a telephone interview.

ACP developed its recommendations based on a review of the latest evidence on the safety and effectiveness of testosterone treatment in men with age-related low testosterone. The studies looked at the effectiveness of the treatments for sexual function, physical function, quality of life, vitality, depression, cognition, and serious side effects such as heart disease, stroke and increased risk of death.

The recommendations are designed to give doctors guidance on how to advise men who ask about the treatments.

Testosterone levels decline about 1.6 percent per year starting in the mid-30s. About 20 percent of men age 60 and older have low testosterone, and that figure rises to 30 percent for men in their 70s and to 50 percent for men in their 80s.

Based on the review, ACP found that men with age-related low testosterone who have sexual dysfunction might get a slight benefit from the treatments, but the evidence is lacking to support their use to improve energy, physical function or cognition.

In an unusual move, the group also looked at the cost of these treatments and found that based on Medicare claims data from 2016, injections were far cheaper than gels or patches. Specifically, they found that in 2016, testosterone replacement therapy cost $2,135.32 for transdermal therapy per year, but just $156.24 for injections.

The recommendations do not apply to men with disorders of the hypothalamus, pituitary gland or testes that cause low testosterone.

Although some individual studies have suggested that testosterone replacement therapy might increase the risk for cardiovascular events, evidence from the 14 trials reviewed by the ACP was too weak to allow for any firm conclusions on heart safety.

As to whether the drugs increase the risk of prostate cancer or death, the researchers concluded that there was not enough evidence to make a call.

“The evidence is still early and minimal,” Dr. Julie Wood of the American Academy of Family Physicians, which endorsed the guidelines, said in a telephone interview.

“Where I think we’re still lacking evidence in many areas is in long-term evidence as far as potential risks,” said Wood, who was not involved in the evidence review.

“We may in a few years have that evidence about cardiovascular disease and prostate cancer and other issues. This is what we know right now,” she said.

SOURCE: Annals of Internal Medicine, online January 6, 2020.