Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes

作者：Hertzel C. Gerstein, Naveed A. Sattar, Julio Rosenstock, Chinthanie F. Ramasundarahettige, Richard E. Pratley, Renato D. Lópes, Carolyn S.P. Lam, Nardev Singh Khurmi, Laura Heenan, Stefano Del Prato, Leanne Dyal, Kelley R. Branch · 发表于：New England Journal of Medicine · 年份：2021 · DOI：10.1056/nejmoa2108269 · 被引用次数：824 · 研究领域：Diabetes Treatment and Management、Hyperglycemia and glycemic control in critically ill and hospitalized patients、Diabetes, Cardiovascular Risks, and Lipoproteins

BACKGROUND: Four glucagon-like peptide-1 (GLP-1) receptor agonists that are structurally similar to human GLP-1 have been shown to reduce the risk of adverse cardiovascular events among persons with type 2 diabetes. The effect of an exendin-based GLP-1 receptor agonist, efpeglenatide, on cardiovascular and renal outcomes in patients with type 2 diabetes who are also at high risk for adverse cardiovascular events is uncertain. METHODS: of body-surface area) plus at least one other cardiovascular risk factor. Participants were randomly assigned in a 1:1:1 ratio to receive weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg or placebo. Randomization was stratified according to use of sodium-glucose cotransporter 2 inhibitors. The primary outcome was the first major adverse cardiovascular event (MACE; a composite of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular or undetermined causes). RESULTS: A total of 4076 participants were enrolled; 2717 were assigned to receive efpeglenatide and 1359 to receive placebo. During a median follow-up of 1.81 years, an incident MACE occurred in 189 participants (7.0%) assigned to receive efpeglenatide (3.9 events per 100 person-years) and 125 participants (9.2%) assigned to receive placebo (5.3 events per 100 person-years) (hazard ratio, 0.73; 95% confidence interval [CI], 0.58 to 0.92; P<0.001 for noninferiority; P = 0.007 for superiority). A composite renal outcome event (a decrease in kidney f...