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 warn the popular treatment is no “anti-aging
tonic.”
The research, published Friday in the New England Journal of
Medicine, found that heart attacks, strokes and other major cardiac issues were
no more common among those using testosterone gel than those using a placebo.
That implies the gel is also safe for men without
cardiovascular problems who have low T, said Dr. Steven Nissen, a cardiologist
at the Cleveland Clinic and senior author of the study. But, he added, it
doesn’t mean the treatment should be used by men without low T — a condition
also known as hypogonadism that’s measured by levels of the sex hormone in the
blood.
“What we’ve shown here is that for a very specific group of
men, testosterone can be given safely,” Nissen said. “But it is not to be given
as an anti-aging tonic for widespread use in men who are aging.”
More than 5,000 men ages 45-80 at 316 trial sites throughout
the U.S. were randomly assigned to get the testosterone gel or the placebo,
which they rubbed on their skin daily for an average of about 22 months. “Major
cardiac events” occurred in 182 patients in the testosterone group and 190
patients in the placebo group.
The testosterone group did have a higher incidence of less
severe problems, such as atrial fibrillation, acute kidney injury and issues
from blood clots in veins.
The large study helps address “a gap of understanding” about
how testosterone treatment affects cardiovascular outcomes for men with true
low T, said Dr. Alan Baik, a cardiologist at the University of California-San
Francisco who was not involved in the research.
But he’d like to see more research, he said, on whether
testosterone therapy can actually reduce cardiovascular risk factors in men
with low T, who seem more likely to have conditions like high blood pressure
and diabetes.
Treating low T has been a big business for many years,
largely driven by advertisements for pills, patches, gels and injections.
Online sites and clinics across the nation offer the treatment, and many tie
low T to common issues such as 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 for makers of testosterone products to carefully
examine the risk of heart attack or stroke. A previous FDA review had shown
that many men got low T treatment even though their testosterone levels hadn’t
been checked.
Nissen said 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, “should not be used by
bodybuilders. It should not be used by athletes. The concerns about the misuse
of testosterone are quite high. And I think we have to be very cautious.” -AP