Table 4. Prespecified adverse events (AEs) and study drug discontinuation according to duration of heart failure* .
| HF ≥2 months-1 year | HF >1-2 years | HF >2-5 years | HF >5 years | P for interaction | |||||
|---|---|---|---|---|---|---|---|---|---|
| Placebo (n=566) | Dapa (n=530) | Placebo (n=366) | Dapa (n=319) | Placebo (n=527) | Dapa (n=577) | Placebo (n=909) | Dapa (n=942) | ||
| Any discontinuation – no. (%) | 57 (10.1) | 47 (8.9) | 43 (11.8) | 32 (10.0) | 53 (10.1) | 59 (10.2) | 105 (11.6) | 111 (11.8) | 0.87 |
| Discontinuation due to AE – no. (%) | 18 (3.2) | 13 (2.5) | 13 (3.6) | 19 (6.0) | 31 (5.9) | 27 (4.7) | 54 (5.9) | 52 (5.5) | 0.36 |
| Adverse events – no. (%) | |||||||||
| Volume depletion | 21 (3.7) | 30 (5.7) | 14 (3.8) | 18 (5.6) | 38 (7.2) | 55 (9.5) | 89 (9.8) | 75 (8.0) | 0.05 |
| Renal | 22 (3.9) | 25 (4.7) | 17 (4.6) | 16 (5.0) | 48 (9.1) | 43 (7.5) | 83 (9.1) | 69 (7.3) | 0.27 |
| Fracture | 10 (1.8) | 9 (1.7) | 6 (1.6) | 4 (1.3) | 12 (2.3) | 11 (1.9) | 22 (2.4) | 25 (2.7) | 0.94 |
| Amputation | 1 (0.2) | 2 (0.4) | 0 (0) | 3 (0.9) | 3 (0.6) | 1 (0.2) | 8 (0.9) | 7 (0.7) | - |
| Major hypoglycaemia | 1 (0.2) | 1 (0.2) | 0 (0) | 1 (0.3) | 3 (0.6) | 0 (0) | 0 (0) | 2 (0.2) | - |
*
Only in the safety set except for discontinuation due to any cause