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Table 3 Cardiovascular trials in diabetes completed in 2021: comparison of active vs. placebo group

From: Report from the CVOT Summit 2021: new cardiovascular, renal, and glycemic outcomes

FIGARO-DKD [36]—Finerenone AMPLITUDE-O [35]—Efpeglenatide
Class and cardiovascular outcomes HR (95% CI), p-value Class and cardiovascular outcomes HR (95% CI), p-value
Number of participants 7437 Number of participants 4076
Primary composite outcome Primary composite outcome
 Composite of CV death, nonfatal MI, nonfatal stroke, and HHF 0.87 (0.76–0.98), p = 0.03  Incident MACE 0.73 (0.58–0.92), +p < 0.001
Secondary outcome Secondary outcome
 Composite of onset of kidney failure, sustained ≥ 40% eGFR decline or death from renal causes 0.87 (0.76–1.01)  Expanded MACE composite outcome event 0.79 (0.65–0.96), *p = 0.02
Secondary outcome Secondary outcome
 Hospitalization for any cause 0.97 (0.90–1.04)  Composite renal outcome event 0.68 (0.57–0.79), *p < 0.001
Secondary outcome   
 All-cause mortality 0.89 (0.77–1.04)   
Secondary outcome   
 Kidney composite outcome 0.77 (0.60–0.99)   
Adverse events Event rate (%) active vs. placebo group Adverse events Event rate (%) active vs. placebo group (p-value)
Hyperkalemia 10.8 vs. 5.3 Severe gastrointestinal event  3.3 vs. 1.8 (p=0.009)
Hypokalemia 1.1 vs. 2.4   
Gynecomastia 0.1 vs. 0.1   
  1. +p-value for noninferiority
  2. *p-value for superiority