Rates of death from cardiovascular causes were similar in the two groups. Nonfatal myocardial infarction occurred in 2.9% of the patients receiving semaglutide and in 3.9% of those receiving placebo (hazard ratio, 0.74 95% CI, 0.51 to 1.08 P=0.12) nonfatal stroke occurred in 1.6% and 2.7%, respectively (hazard ratio, 0.61 95% CI, 0.38 to 0.99 P=0.04).
The primary outcome occurred in 108 of 1648 patients (6.6%) in the semaglutide group and in 146 of 1649 patients (8.9%) in the placebo group (hazard ratio, 0.74 95% confidence interval, 0.58 to 0.95 P<0.001 for noninferiority). The noninferiority margin was 1.8 for the upper boundary of the 95% confidence interval of the hazard ratio.Īt baseline, 2735 of the patients (83.0%) had established cardiovascular disease, chronic kidney disease, or both. We hypothesized that semaglutide would be noninferior to placebo for the primary outcome. The primary composite outcome was the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke.
We randomly assigned 3297 patients with type 2 diabetes who were on a standard-care regimen to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks. The cardiovascular effects of semaglutide, a glucagon-like peptide 1 analogue with an extended half-life of approximately 1 week, in type 2 diabetes are unknown. Regulatory guidance specifies the need to establish cardiovascular safety of new diabetes therapies in patients with type 2 diabetes in order to rule out excess cardiovascular risk.
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