Testosterone ‘Safe’ for Most Older Men with Low Testosterone
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.
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