Randomised controlled trial
Cardiovascular Safety of Testosterone-Replacement Therapy
- Randomised controlled trial
- multicentre
- double-blind
- placebo-controlled
- non-inferiority
Mean (±SD) treatment duration 21.7±14.1 months; mean follow-up 33.0±12.1 months
Authors' conclusion
In men with hypogonadism and preexisting or a high risk of cardiovascular disease, testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events.
Study context
- Population
- Men 45 to 80 years with preexisting or high risk of CVD, symptoms of hypogonadism and two fasting testosterone levels <300 ng per deciliter
- Participants
- 5,246 men
- Comparison
- Testosterone gel vs placebo gel
- Primary endpoint
- First MACE: CV death, nonfatal MI or nonfatal stroke (time-to-event)
Primary result
As reported in the abstract
Hazard ratio
0.96
95% CI 0.78–1.17
P < 0.001
Events by treatment group
Testosterone vs Placebo
HR 0.96 (95% CI 0.78–1.17); P < 0.001
Secondary outcomes
Sensitivity analyses (events censored at various times after discontinuation)
- Similar findings
Secondary end point (CV death, nonfatal MI, nonfatal stroke or coronary revascularization) and each component of the primary end point
- Incidence appeared similar in the two groups
Original publication
Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. Published 16 June 2023. doi:10.1056/nejmoa2215025
Summarised from the published abstract; every number is checked against it