Study Explores Testosterone Replacement Therapy and Cardiac Safety

CLEVELAND – Many American men have turned to testosterone replacement therapy, but little is known about how it impacts men’s health, specifically the heart.

So, the Food and Drug Administration (FDA) required the makers of testosterone therapies to conduct safety trials to learn more.

Cleveland Clinic led one of the studies.

“The question we were asking was, were there more cardiovascular events in men who were getting testosterone compared to men who are getting a placebo? The answer is that there were not,” said senior author Steven Nissen, MD, Chief Academic Officer of the Heart, Vascular & Thoracic Institute at Cleveland Clinic. “There were almost identical numbers of events in the placebo group and in the men taking testosterone. However, it is very important that we not over-interpret the findings. This was a very specific group of patients.”

Dr. Nissen and his team studied 5,246 men between the ages of 45 and 80 with low testosterone.

Participants had heart disease or were at high risk and were experiencing symptoms of low testosterone like decreased sexual desire, loss of body hair and depression.

They were split into two groups – one received testosterone gel and the other placebo.

Results show testosterone treatment was not unsafe in regard to major heart-related issues, including heart attack and stroke.

However, there were some other safety concerns.

“There was a higher rate of venous thromboembolism, that’s clots in the legs – wasn’t a large number, but there was an imbalance toward testosterone,” explained Dr. Nissen. “And in fact, the current guidelines suggest that men who have had clots in their legs should not be treated with testosterone. That was probably the most important and most serious adverse event that was observed.”

Dr. Nissen said the testosterone group also experienced more kidney issues and A-fib, which is an irregular heart rhythm.

He cautions men about using testosterone therapy unless it’s really needed and said it’s best to talk to your doctor about appropriate blood tests and treatment options.