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 | Â | Â | |
 All-cause mortality | 0.89 (0.77–1.04) |  |  |
Secondary outcome | Â | Â | |
 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 | Â | Â |
Gynecomastia | 0.1 vs. 0.1 | Â | Â |