TRAVERSE Trial Clears Testosterone on Heart Risk in 5,246 Men, Flags Clot and AFib Concerns
Updated
Updated · AOL · Jul 29
TRAVERSE Trial Clears Testosterone on Heart Risk in 5,246 Men, Flags Clot and AFib Concerns
3 articles · Updated · AOL · Jul 29
Summary
5,246 men in the TRAVERSE trial showed no meaningful rise in cardiovascular death, heart attack or stroke with testosterone therapy versus placebo over a mean 33 months of follow-up.
7.0% of testosterone patients hit the primary endpoint versus 7.3% on placebo, producing a hazard ratio of 0.96 and meeting the study’s noninferiority goal.
0.9% of men on testosterone developed pulmonary embolism versus 0.5% on placebo, while investigators also reported higher rates of atrial fibrillation and acute kidney injury.
2015 FDA pressure drove the trial after conflicting earlier studies, but researchers stressed the findings apply only to men with confirmed hypogonadism and symptoms—not broad use through “low T” clinics.
Doctors say the results ease a long-running heart-safety concern, while shifting attention to which patients may still face higher clotting or arrhythmia risk.