08/03/2023
🧭 10-second takeaway
Testosterone replacement therapy (TRT) is frequently used to treat symptoms of hypogonadism in men, but previous studies have provided conflicting information about its cardiovascular safety. In this large-scale study, TRT in men with preexisting or a high risk of cardiovascular disease (CVD) was noninferior to placebo for the incidence of major adverse cardiac events (MACE), but was associated with a higher incidence of atrial fibrillation, acute kidney injury, and pulmonary embolism. Because testosterone deficiency is not life-threatening, clinicians should continue to individualize the decision to begin TRT.
Study breakdown
👥 Study population: 5204 men aged 45–80 years with preexisting or a high risk of CVD, symptoms of hypogonadism, and two morning testosterone levels < 300 ng/dL
Methods: noninferiority, multicenter, randomized, double-blind, placebo-controlled trial
- Randomized 1:1 to daily transdermal 1.62% testosterone gel (TRT group) or placebo gel
- The testosterone dose in the TRT group was adjusted to maintain a testosterone level between 350 and 750 ng/dL.
- Primary endpoint: first MACE, i.e., death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke
- Mean duration of treatment: 22 ± 14 months; mean follow-up: 33 ± 12 months
Main results
- TRT was noninferior to placebo for incidence of MACE: 7.0% in the TRT group vs. 7.3% in the placebo group (HR, 0.96; 95% CI, 0.78–1.17)
- The incidence of several adverse effects was higher in the TRT group than the placebo group.
• Atrial fibrillation: 3.5% vs. 2.3%
• Acute kidney injury: 2.3% vs. 1.5%
• Pulmonary embolism: 0.9% vs. 0.5%
Limitations include: Adherence and retention rates were low.
Study funding: AbbVie, Acerus Pharmaceuticals, Endo Pharmaceuticals, Upsher-Smith Laboratories
⭐️ Sign up for the free ➡️ https://go.amboss.com/omt_fb_109