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Semaglutidi ja kardiovaskulaaritapahtumat korkean kardiovaskulaaririskin omaavilla tyypin 2 diabetesta sairastavilla potilailla

Näytönastekatsaukset
Jorma Komulainen
7.2.2018

Näytön aste: C

Tyypin 2 diabetestaa sairastavilla, joilla on korkea kardiovaskulaaririski ja suboptimaalinen glykemiataso, semaglutidin lisääminen muuhun glykemialääkitykseen näyttää vähentävän vaikeiden kardiovaskulaaritapahtumien riskiä.

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%).

  • Study quality: High
  • Applicability: Results may not be generalized to T2D patients with lower cardiovascular risk.
  • Comment: It is possible, that the decreased risk for serious cardiovascular outcomes were caused by the greater decrease in glycated hemoglobin levels.

Kirjallisuutta

  1. Marso SP, Bain SC, Consoli A ym. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med 2016;375:1834-1844 «PMID: 27633186»PubMed