Cardiovascular Safety of Testosterone-Replacement Therapy
Primary resultResult — go to the resultHazard ratio 0.96 95% CI 0.78–1.17Authors' 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)
Methodological detailsmulticentre, double-blind, placebo-controlled, non-inferiority, Mean (±SD) treatment duration 21.7±14.1 months; mean follow-up 33.0±12.1 months
- Multicentre
- Double-blind
- Placebo-controlled
- Non-inferiority
- Mean (±SD) treatment duration 21.7±14.1 months; mean follow-up 33.0±12.1 months
Primary result
As reported in the abstract
Hazard ratio
0.96
95% CI 0.78–1.17
P < 0.001 for noninferiority
Events by treatment group
Testosteronevs Placebo
HR 0.96 (95% CI 0.78–1.17); P < 0.001 for noninferiority
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.
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