Among patients with Type 2 Diabetes, high cardiovascular risk and suboptimal glycemic balance, adding semaglutide to other glycemia treatment seems to decrease the risk of serious cardiovascular outcomes.
In a multicentre RCT study «Marso SP, Bain SC, Consoli A ym. Semaglutide and C...»1, 3 297 patients with type 2 diabetes and on a standard care regimen, were randomized to receive once-weekly semaglutide (0.5 or 1.0 mg) or placebo for 2 years. The primary composite outcome was the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The study was designed as a noninferiority study.
At baseline, 2735 of the patients (83.0%) had established cardiovascular disease, chronic kidney disease, or both. 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 (CI), 0.58 to 0.95; P<0.001 for noninferiority; P = 0.02 for superiority). 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). Rates of death from cardiovascular causes were similar in the two groups.
At week 104, among patients receiving semaglutide, the mean glycated hemoglobin level decreased from 8.7% at baseline to 7.6% in the group receiving 0.5 mg and to 7.3% in the group receiving 1.0 mg. In the placebo group, the mean level decreased to 8.3%. Thus, both semaglutide groups experienced greater decrease in HbA1c levels than placebo group (P<0.001).
Gastrointestinal disorders were more frequent in the semaglutide group than in the placebo group (51% vs. 35%). Treatment discontinuation because of adverse events (mainly gastrointestinal) was more frequent in the semaglutide group than in the placebo group (13% vs. 7%).