A new study from Intermountain Medical Center Heart Institute presented this month at the 2016 American College of Cardiology Scientific Session in Chicago shows that patients who received testosterone as part of their follow-up treatment faired much better than patients who didn’t.
Researcher found that non-testosterone-therapy patients were 80 percent more likely to suffer a major adverse cardiovascular event — including strokes, heart attacks and death. Results from the study corroborate findings of another Intermountain study from 2015.
“It adds further evidence that testosterone replacement to normal levels in androgen deficient men does not increase cardiovascular risk,” said Brent Muhlestein, a cardiovascular researcher with the Intermountain Medical Center Heart Institute. “This was the case even in the highest-risk men: those with known pre-existing heart disease.”
How was the study conducted?
The research team studied 755 male patients at Intermountain Healthcare hospitals. The men were between the ages of 58 and 78, and all had severe coronary artery disease. They were split into three different groups that received varied doses of testosterone administered either by injection or gel.
What were the results?
After one year, the number of patients who suffered major adverse cardiovascular included:
- 64 non-testosterone-therapy patients
- 12 medium-dose-testosterone patients
- 9 high-dose-testosterone patients
- 125 non-testosterone-therapy patients
- 38 medium-dose-testosterone patients
- 22 high-dose patients testosterone patients
“This study actually indicates that men with low testosterone levels who have coronary artery disease might actually be protected through testosterone replacement, but this observational study is not enough to recommend changing treatment based,” said Dr. Muhlestein. “It does, however, justify a randomized clinical trial designed to confirm or refute the results of our study.”
Last year, the U.S. Food and Drug Administration required manufacturers of all approved testosterone products to add labels outlining the coronary risks of testosterone supplementation.
“The FDA’s warning was based on the best clinical information available at the time,” Dr. Muhlestein said. “As further information, like this study, becomes available, and especially after a large randomized clinical outcomes trial can be accomplished, hopefully the FDA will be able to change its warning.”