Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes
| Autor: | Gerstein H, Sattar N, Rosenstock J, Ramasundarahettige C, Pratley R, Lopes R, Lam C, Khurmi N, Heenan L, Del Prato S, Dyal L, Branch K, AMPLITUDE-O Trial Investigators |
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| Rok vydání: | 2021 |
| Zdroj: | NEW ENGLAND JOURNAL OF MEDICINE r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA instname |
| ISSN: | 0028-4793 |
| Popis: | Cardiovascular and Renal Outcomes with Efpeglenatide This trial compared weekly injections of efpeglenatide, an exendin-based glucagon-like peptide-1 receptor agonist, at a dose of 4 or 6 mg with placebo in participants with known type 2 diabetes and either a history of cardiovascular disease or current kidney disease plus at least one other cardiovascular risk factor. The risk of cardiovascular events was lower with efpeglenatide. 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 In this randomized, placebo-controlled trial conducted at 344 sites across 28 countries, we evaluated efpeglenatide in participants with type 2 diabetes and either a history of cardiovascular disease or current kidney disease (defined as an estimated glomerular filtration rate of 25.0 to 59.9 ml per minute per 1.73 m(2) 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 |
| Databáze: | OpenAIRE |
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