(RxWiki News) Less than a year after the US Food and Drug Administration (FDA) voted for stricter labeling of testosterone drugs, new evidence suggests these drugs may not be as bad for men's hearts as previously thought.
A new study from Intermountain Medical Center (IMC) in Salt Lake City found that testosterone replacement therapy (TRT) was not linked to an increased risk of stroke, heart attack or death in generally healthy men.
"Our research examined the potential cardiovascular risks associated with generally healthy men who use testosterone supplements to normalize their levels and found no increase in those risk factors," said study co-author Joseph B. Muhlestein, MD, a cardiologist at IMC, in a press release. "In fact, testosterone therapy in this population was shown to reduce the risk of heart attack, stroke and death, when compared to those men who weren't taking testosterone supplementation."
In early 2015, the FDA issued a new rule requiring manufacturers to clearly mention that TRT may increase stroke and heart attack risk on their products' labels.
Testosterone is a hormone that helps maintain men's bone density, fat distribution, muscle strength and mass, facial and body hair, red blood cell production, sex drive and sperm production.
While testosterone levels naturally decline as men age, low testosterone can also be caused by a disease called hypogonadism. In this disease, the body is unable to produce a normal amount of testosterone due to a problem in the testicles or the pituitary gland.
In the case of hypogonadism, testosterone (in the form of injections, pellets, patches or gels) can be prescribed to ease symptoms. In the case of normal aging, however, TRT is not currently recommended.
For this study, Dr. Muhlestein and team looked at 1,472 men between ages 52 and 63 who had low testosterone levels and no history of heart problems.
During follow-ups after one and three years, these researchers found that TRT used to achieve normal testosterone levels did not increase the risk of heart attack, stroke or death in these men.
According to Dr. Muhlestein and team, these findings provide further evidence of the cardiovascular safety of TRT in generally healthy men over age 50.
This study was published Nov. 9 at the 2015 American Heart Association Scientific Sessions. Research presented at conferences may not have been peer-reviewed.
Information on funding sources and conflicts of interest was not available at the time of publication.