Table 2.
Safety outcomes by treatment and estimated glomerular filtration rate category
| eGFR ≤30 mL/min/1.73 m2 | 30 < eGFR ≤60 mL/min/1.73 m2 | eGFR >60 mL/min/1.73 m2 | Overall (n = 4956) | ||||
|---|---|---|---|---|---|---|---|
| Vericiguat (n = 261) | Placebo (n = 246) | Vericiguat (n = 1060) | Placebo (n = 1070) | Vericiguat (n = 1153) | Placebo (n = 1166) | ||
| Syncope | 11 (4.2) | 10 (4.1) | 48 (4.5) | 38 (3.6) | 41 (3.6) | 37 (3.2) | 185 (3.7) |
| Symptomatic hypotension | 29 (11.1) | 22 (8.9) | 109 (10.3) | 98 (9.2) | 86 (7.5) | 72 (6.2) | 416 (8.4) |
| Hyperkalaemia | 21 (8.0) | 25 (10.2) | 71 (6.7) | 84 (7.9) | 29 (2.5) | 39 (3.3) | 269 (5.4) |
| Treatment discontinuation | 144 (55.2) | 138 (56.1) | 436 (41.1) | 435 (40.7) | 371 (32.2) | 368 (31.6) | 1892 (38.2) |
| Reason for discontinuation | |||||||
| Adverse event | 30 (20.8) | 32 (23.2) | 83 (19.0) | 75 (17.2) | 59 (15.9) | 50 (13.6) | 329 (17.4) |
| Death | 55 (38.2) | 57 ((41.3) | 156 (35.8) | 173 (39.8) | 141 (38.0) | 149 (40.5) | 731 (38.6) |
| Lost to follow‐up | 2 (1.4) | 2 (1.4) | 2 (0.5) | 2 (0.5) | 4 (1.1) | 7 (1.9) | 19 (1.0) |
| Non‐compliance with study drug | 2 (1.4) | 6 (4.3) | 23 (5.3) | 24 (5.5) | 22 (5.9) | 19 (5.2) | 96 (5.1) |
| Physician decision | 30 (20.8) | 22 (15.9) | 78 (17.9) | 70 (16.1) | 65 (17.5) | 62 (16.8) | 327 (17.3) |
| Protocol deviation | 1 (0.7) | 1 (0.7) | 4 (0.9) | 1 (0.2) | 3 (0.8) | 0 (0.0) | 10 (0.5) |
| Withdrawal by patient | 24 (16.7) | 18 (13.0) | 90 (20.6) | 90 (20.7) | 77 (20.8) | 81 (22.0) | 380 (20.1) |
| Worsening renal function by 16 weeks | 47/210 (22.4) | 35/184 (19.0) | 183/892 (20.5) | 173/921 (18.8) | 116/1016 (11.4) | 92/1041 (8.8) | 646/4264 (15.2) |
Data presented as n (%).
eGFR, estimated glomerular filtration rate.