Testosterone therapy may reduce the risk of major cardiovascular events, such as stroke, heart attack, and death, in older men with low testosterone levels and pre-existing coronary artery disease, according to a new study at Intermountain Medical Center Heart Institute.
For the study, the researchers evaluated 755 male patients, ages 58 to 78, at Intermountain Healthcare hospitals. All participants had severe coronary artery disease. They were split into three different groups, with each group receiving a different dose of testosterone administered either by injection or gel.
The findings reveal that patients who received testosterone fared much better than those who didn’t. In fact, non-testosterone-therapy patients were 80 percent more likely to suffer an adverse event.
Specifically, 64 patients who weren’t taking testosterone supplements suffered major adverse cardiovascular events after one year, while only 12 who were taking medium doses of testosterone and nine who were taking high doses did.
Three years later, 125 non-testosterone-therapy patients suffered major adverse cardiovascular events, while only 38 medium-dose and 22 high-dose patients did.
“The study shows that using testosterone replacement therapy to increase testosterone to normal levels in androgen-deficient men doesn’t increase their risk of a serious heart attack or stroke,” said cardiologist Brent Muhlestein, M.D., co-director of cardiovascular research at the Intermountain Medical Center Heart Institute.
“That was the case even in the highest-risk men — those with known pre-existing heart disease.”
The researchers are still cautious in their findings as more research is needed to draw final conclusions..
“Although this study indicates that hypo-androgenic men with coronary artery disease might actually be protected by testosterone replacement, this is an observational study that doesn’t provide enough evidence to justify changing treatment recommendations,” said Muhlestein.
“It does, however, substantiate the need for a randomized clinical trial that can confirm or refute the results of this study.”
The new findings support the results of another Intermountain study published in 2015, which showed that taking supplemental testosterone did not increase the risk of experiencing a heart attack or stroke for men with low testosterone levels and no history of heart disease.
Both of these studies address a recent mandate by the U.S. Food and Drug Administration which 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,” said Muhlestein. “As further information, like our research, becomes available — and especially after a large randomized clinical outcomes trial can be accomplished — hopefully the FDA will be able to change its warning.”
The Intermountain Medical Center research team will present results of the study at the American College of Cardiology’s 65th Annual Scientific Session.
Source: Intermountain Medical Center