AMPLITUDE-O Trial: CV and Renal Outcomes with Efpeglenatide

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2021 AMPLITUDE-O TRIAL M Cardiovascular and renal outcomes with efpeglenatide in type 2 diabetes international, randomized, controlled trial Objective: To evaluate efpeglenatide in participants with type 2 diabetes and either a history of cardiovascular disease or current kidney disease 4076 patients Inclusion criteria: Participants ≥18 years of age with type 2 diabetes mellitus and history of cardiovascular disease or kidney disease and ≥1 additional cardiovascular risk factor Efpeglenatide group (n=2717) 7.0 0- Placebo group (n=1359) PRIMARY OUTCOME Major adverse cardiovascular event% HR 0.73; 95% CI, 0.58 to 0.92; P< 0.001 for noninferiority SECONDARY OUTCOME 9.2 Composite renal outcome event% 13.0 18.4 HR 0.68; 95% CI, 0.57 to 0.79; P< 0.001 7.9 MACE or death from noncardiovascular cause% HR 0.73; 95% CI, 0.58 to 0.92; P < 0.001 for noninferiority 10.5 Conclusion: Among participants the risk of cardiovascular events was lower among those who received weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg than among those who received placebo Gerstein HC et al. NEJM 2021;385:896-907