According to a new study, testosterone replacement therapy is safe for men with “low T” who have heart disease or are at high risk for it.
The research, published in the New England Journal of Medicine, suggests that heart attacks, strokes and other major cardiac issues were no more common among those using testosterone gel than those using a placebo.
However, doctors caution that the treatment should not be seen as an “anti-aging tonic” and should only be used for those with medically-diagnosed low testosterone levels and associated symptoms. The study was conducted on men aged 65 or older with low testosterone levels and a history of heart disease or an increased risk for it.
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.”
The study involved over 5,000 men aged 45-80, who were randomly assigned to receive the testosterone gel or placebo, which they applied daily for an average of 22 months.
The study took place at 316 trial sites throughout the United States. Results showed that “major cardiac events” were no more common in the testosterone group than the placebo group, although there were a higher number of less severe problems in the testosterone group, such as atrial fibrillation, acute kidney injury and issues from blood clots in veins.
Dr. Alan Baik, a cardiologist at the University of California-San Francisco who was not involved in the research, comments that the study addressed a gap in understanding about how testosterone treatment affects cardiovascular outcomes in men with true low T.
Dr. Alan Baik expressed the need for more research to determine if testosterone therapy can reduce cardiovascular risk factors in men with low T, who are more likely to have conditions like high blood pressure and diabetes.
Treating low T has been a lucrative industry for many years, driven in part by advertisements for pills, patches, gels, and injections. Online sites and clinics across the nation offer the treatment, often linking low T to common issues such as fatigue and weight gain.
However, medical professionals caution that the treatment should only be used for medically-diagnosed low testosterone levels and associated symptoms, and not be seen as an anti-aging tonic.
The new study, which was led by the Cleveland Clinic and funded by a consortium of drug companies, was conducted in response to a 2015 mandate by the Food and Drug Administration (FDA).
The FDA asked manufacturers of testosterone products to carefully examine the risk of heart attack or stroke associated with the treatment, in light of previous evidence showing that many men received low T treatment despite not having their testosterone levels checked.
The results of the study suggest that testosterone gel is safe for men with low T and cardiovascular problems, although doctors warn against using the treatment for anti-aging purposes without a medical reason.
Dr. Nissen acknowledged that the desire to regain youthful vigor and sexual performance is common among aging men, who often seek low T treatment. However, he stressed that testosterone therapy should not be used by bodybuilders or athletes, and that concerns about the misuse of testosterone are quite high.
He emphasized that caution is necessary when using the treatment, and that it should only be prescribed for medically-diagnosed low testosterone levels and associated symptoms. Low T is a common disorder, but the treatment should not be seen as an anti-aging tonic or a performance-enhancing drug, he added.
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