Table 2.
Key safety outcomes by insulin resistance at baseline
| eGDR at baseline | ||||
|---|---|---|---|---|
| eGDR <median | eGDR ≥median | |||
| Finerenone (N = 3,242) | Placebo (N = 3,228) | Finerenone (N = 3,235) | Placebo (N = 3,234) | |
| Treatment-emergent AEs, n (%) | ||||
| Any AE | 2,823 (87.1) | 2,801 (86.8) | 2,751 (85.0) | 2,781 (86.0) |
| Study drug–related AE | 640 (19.7) | 457 (14.2) | 560 (17.3) | 402 (12.4) |
| AE leading to discontinuation | 236 (7.3) | 170 (5.3) | 176 (5.4) | 180 (5.6) |
| Any SAE | 1,107 (34.1) | 1,181 (36.6) | 937 (29.0) | 999 (30.9) |
| Study drug–related SAE | 46 (1.4) | 32 (1.0) | 36 (1.1) | 29 (0.9) |
| SAE leading to discontinuation | 84 (2.6) | 72 (2.2) | 59 (1.8) | 82 (2.5) |
| Fatal AE | 55 (1.7) | 83 (2.6) | 54 (1.7) | 68 (2.1) |
| Treatment-emergent hyperkalemia events, n (%) | ||||
| Any AE | 460 (14.2) | 195 (6.0) | 449 (13.9) | 252 (7.8) |
| Study drug–related AE | 286 (8.8) | 107 (3.3) | 285 (8.8) | 142 (4.4) |
| AE leading to discontinuation | 63 (1.9) | 19 (0.6) | 47 (1.5) | 19 (0.6) |
| Any SAE | 36 (1.1) | 11 (0.3) | 32 (1.0) | 5 (0.2) |
| Study drug–related SAE | 22 (0.7) | 6 (0.2) | 20 (0.6) | 2 (<0.1) |
| SAE leading to discontinuation | 8 (0.2) | 1 (<0.1) | 2 (<0.1) | 1 (<0.1) |
| Fatal AE | 0 | 0 | 0 | 0 |
AE, adverse event; SAE, serious adverse event.