June 16, 2023 -- Testosterone replacement therapy does not appear to raise the risk for heart attacks, strokes, or deaths from either, among middle-aged and older men with low testosterone and high risk for heart disease, the long-awaited results from a major clinical trial find.
Among over ,5000 men aged 45 to 80 years, no increased risk was seen for from cardiovascular causes, nonfatal heart attack or stroke.
There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in one kind of abnormal heart rhythm, atrial fibrillation, acute kidney injury, and blood clots in the lung (pulmonary embolism) in the group who received testosterone replacement therapy compared with those who used a placebo gel.
The FDA required the study was in 2015 in response to concerns and conflicting data regarding the safety of testosterone replacement therapy in men. It was conducted by a group of five manufacturers of testosterone replacement products, led by AbbVie.
The findings were to be presented Saturday at ENDO 2023: The annual meeting of the Endocrine Society. The data was also published in the New England Journal of Medicine.
These results are the first to be reported from the study, called TRAVERSE. Later this year, other findings on so-called ‘efficacy’ outcomes, including sexual function, depressive disorder, fractures, anemia, and diabetes, are expected to be presented at a conference, and/or published in a medical journal.
Taken together, the TRAVERSE findings are expected to transform the risk-benefit discussions with patients about the use of testosterone therapy for low testosterone, study co-author Shalendar Bhasin, MD, said.
“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Bhasin, director of the Research Program in Men’s Health: Aging and Metabolism at the Brigham and Women’s Hospital, in Boston.
“We’ll have much better data on the efficacy side in the next few months,” he added.
‘Real Data on Something That We’ve Been Prescribing for Decades’
Asked to comment, endocrinologist Bradley D. Anawalt MD, said “the community of physicians who prescribe testosterone to men were waiting with bated breath” for the TRAVERSE results.
“Until now, we’ve had to say well, there might be a risk of strokes and heart attacks. This study does a lot to say that’s not a serious risk, in the first few years anyway, of testosterone therapy,,” said Anwalt, professor of medicine at the University of Washington in Seattle
However, Anawalt stressed that the TRAVERSE safety data apply only to men with documented low testosterone.
“It doesn’t give carte blanche to prescribe to men with normal testosterone concentrations. It doesn’t tell us about the safety of that,” he said.