Off-label testosterone linked to heart risks in men with diabetes
Major cardiovascular events occurred in 13.5% of off-label testosterone users versus 12.1% of men treated for confirmed hypogonadism, or low testosterone, over up to 10 years.
Edited by Boris Djordjevic · AgingResearch.News
In an observational cohort study, researchers analyzed health records of 75,717 men aged 30 to 75 with diabetes who started testosterone therapy. They matched 16,894 men prescribed off-label testosterone with 16,894 men treated for confirmed hypogonadism, a testosterone deficiency. Off-label use meant starting testosterone without a hypogonadism diagnosis, low testosterone lab results, or documented sexual dysfunction.
Over up to 10 years, off-label therapy was associated with a higher risk of major cardiovascular events, occurring in 13.5% of men compared with 12.1% of those with confirmed hypogonadism. All-cause mortality was 7.3% in the off-label group compared with 5.1% in the confirmed group. Off-label therapy was also linked to higher risks of heart failure, cardiac arrest, and stroke. Risks of heart attack and pulmonary embolism, a clot in the lungs, showed no statistically robust differences.
Why it matters
For men with diabetes, including older men, the authors said the results support prescribing testosterone in line with guidelines and carefully assessing cardiovascular risk.
Caveats
This observational study of electronic health records, reported as a conference abstract, cannot show that off-label testosterone caused the excess heart complications or deaths. It covered men aged 30 to 75 with diabetes and excluded those with testosterone prescriptions or major cardiovascular or blood-clot events in the three years before starting therapy.
The paper
J. W. Goethe University Frankfurt; University of Lubeck
ESC Congress 2026 Abstract, Oct 26, 2026
Presented at ESC Congress 2026
