Table 2.
AE, n/N (%) | With use of cardiovascular medication | Without use of cardiovascular medication | ||
---|---|---|---|---|
Dapagliflozin | Placebo | Dapagliflozin | Placebo | |
ACEi use | ||||
Any AE leading to discontinuation of the study drug | 39/673 (5.8) | 30/678 (4.4) | 79/1476 (5.4) | 93/1471 (6.3) |
Any SAE* | 211/673 (31.4) | 229/678 (33.8) | 422/1476 (28.6) | 500/1471 (34.0) |
ARB use | ||||
Any AE leading to discontinuation of the study drug | 76/1441 (5.3) | 86/1426 (6.0) | 42/708 (5.9) | 37/723 (5.1) |
Any SAE* | 406/1441 (28.2) | 482/1426 (33.8) | 227/708 (32.1) | 247/723 (34.2) |
Calcium channel blocker use | ||||
Any AE leading to discontinuation of the study drug | 56/1073 (5.2) | 67/1108 (6.0) | 62/1076 (5.8) | 56/1041 (5.4) |
Any SAE* | 311/1073 (29.0) | 412/1108 (37.2) | 322/1076 (29.9) | 317/1041 (30.5) |
β‐blocker use | ||||
Any AE leading to discontinuation of the study drug | 44/843 (5.2) | 46/833 (5.5) | 74/1306 (5.7) | 77/1316 (5.9) |
Any SAE* | 292/843 (34.6) | 345/833 (41.4) | 341/1306 (26.1) | 384/1316 (29.2) |
Diuretic use | ||||
Any AE leading to discontinuation of the study drug | 56/927 (6.0) | 57/953 (6.0) | 62/1222 (5.1) | 66/1196 (5.5) |
Any SAE* | 330/927 (35.6) | 391/953 (41.0) | 303/1222 (24.8) | 338/1196 (28.3) |
Antithrombotic agent use | ||||
Any AE leading to discontinuation of the study drug | 52/1022 (5.1) | 62/1018 (6.1) | 66/1127 (5.9) | 61/1131 (5.4) |
Any SAE* | 368/1022 (36.0) | 414/1018 (40.7) | 265/1127 (23.5) | 315/1131 (27.9) |
Lipid‐lowering agent use | ||||
Any AE leading to discontinuation of the study drug | 18/320 (5.6) | 25/325 (7.7) | 100/1829 (5.5) | 98/1824 (5.4) |
Any SAE* | 99/320 (30.9) | 120/325 (36.9) | 534/1829 (29.2) | 609/1824 (33.4) |
ACEi indicates angiotensin‐converting enzyme inhibitor; AE, adverse event; ARB, angiotensin receptor blockers; and SAE, serious adverse event.
Includes death.