June 16, 2023 – The highly anticipated results of a big clinical trial show that testosterone substitute therapy in middle-aged and older men with low testosterone levels and high risk for heart disease doesn't appear to extend the chance of heart attacks, strokes or death from these conditions.
In over 5,000 men between the ages of 45 and 80, no increased risk of cardiovascular causes, non-fatal heart attack or stroke was found.
An increased risk of prostate cancer was also not found through the 33-month commentary period. However, the group that received testosterone substitute therapy had the next incidence of cardiac arrhythmia, atrial fibrillation, acute kidney failure and blood clots within the lungs (pulmonary embolism) in comparison with the group that used a placebo gel.
The FDA requested the study in 2015 in response to concerns and conflicting data in regards to the safety of testosterone substitute therapy in men. It was conducted by a gaggle of 5 testosterone substitute product manufacturers led by AbbVie.
The results were to be presented on Saturday at ENDO 2023: the annual meeting of the Endocrine Society. The data were also presented within the New England Journal of Medicine.
These results are the primary to be announced from the trial, called TRAVERSE. Additional findings on so-called “efficacy” outcomes, including sexual function, depressive disorders, bone fractures, anemia and diabetes, are expected to be presented at a conference and/or published in a medical journal later this 12 months.
Overall, the findings from the TRAVERSE trial are expected to fundamentally change the risk-benefit discussion with patients in regards to the use of testosterone therapy for low testosterone levels, said study co-author Dr. Shalendar Bhasin.
“Testosterone deficiency, to our knowledge, does not lead to death, but it is a serious symptomatic condition that impacts quality of life. Many middle-aged and older men seek help for these symptoms, so it is a serious condition and treatment decisions are complicated,” said Bhasin, director of the Men's Health Research Program: Aging and Metabolism at Brigham and Women's Hospital in Boston.
“We will have much better data on efficacy in the next few months,” he added.
“Real data on something we have been prescribing for decades”
When asked for comment, endocrinologist Bradley D. Anawalt MD said that “the doctors who prescribe testosterone to men have been waiting with bated breath” for the outcomes of the TRAVERSE trial.
“Until now, we have had to say that there may be a risk of strokes and heart attacks. This study clearly shows that this is not a serious risk, at least in the first few years of testosterone therapy,” said Anwalt, a professor of drugs on the University of Washington in Seattle.
However, Anawalt emphasized that the security data on TRAVERSE only apply to men with proven low testosterone levels.
“It doesn't give us carte blanche to treat men with normal testosterone levels with this drug. It doesn't tell us anything about safety,” he said.