Testosterone replacement therapy is safe for men with “low T” who have heart disease or are at high risk for it, a new study suggests.
But doctors caution that the popular treatment is not an “anti-aging tonic.”
The research, published Friday in the New England Journal of Medicine, found that heart attack, stroke and other major cardiovascular problems were no more common among those using a testosterone gel than among those using a placebo.
This means the gel is safe even for men without heart problems who have low T, said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and senior author of the study. But, he added, that doesn’t mean the treatment should be used by men without low T — a condition also known as hypogonadism that is measured by sex hormone levels in the blood.
“We have shown here that for a very specific group of men, testosterone can be given safely,” Nissen said. “But it should not be given as an anti-aging tonic for widespread use in aging men.”
More than 5,000 men aged 45-80 at 316 trial sites across the US were randomly assigned to receive either a testosterone gel or a placebo, which they rubbed on their skin for an average of about 22 months. “Major cardiovascular events” occurred in 182 patients in the testosterone group and 190 patients in the placebo group.
The testosterone group had a higher incidence of less serious problems, such as atrial fibrillation, acute kidney injury and problems with blood clots in the veins.
Cardiologist Dr. Alan Back of the University of California-San Francisco said the large study helps address a “gap of understanding” about how testosterone treatment affects cardiovascular outcomes for men with true low T.
But he’d like to see more research, he said, to see whether testosterone therapy can actually reduce cardiovascular risk factors in men with low T, who are more prone to conditions such as high blood pressure and diabetes.
Treating low T has been big business for many years, driven primarily by advertisements for pills, patches, gels, and injections. Online sites and clinics around the country offer treatment, and many link low T to common issues like fatigue and weight gain.
The new study, led by the Cleveland Clinic and funded by a consortium of drug companies, was done in response to a 2015 mandate by the Food and Drug Administration to carefully examine the risk of heart attack or stroke for manufacturers of testosterone products Was. A previous FDA review had shown that many men who received low T treatment had not had their testosterone levels checked.
Nissen said that while low T is a “very common disorder,” aging men also want to feel like they’re 18 again and have “the sexual performance they had when they were young,” he said.
But the treatment, he added, “shouldn’t be used by bodybuilders. It shouldn’t be used by athletes. The concern about testosterone abuse is quite high. And I think we have to be very, very cautious.”
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