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
