Table 2.
Effects of dapagliflozin compared with placebo on clinical events according to aetiology
| Outcome | Ischaemic (n = 2674) | Non‐ischaemic (n = 2070) | P‐value for interaction | ||
|---|---|---|---|---|---|
| Placebo (n = 1358) | Dapagliflozin (n = 1316) | Placebo (n = 1013) | Dapagliflozin (n = 1057) | ||
| Worsening HF event or cardiovascular death | 0.55 | ||||
| n (%) | 289 (21.3) | 223 (16.9) | 213 (21.0) | 163 (15.4) | |
| Event rate per 100 person‐years (95% CI) | 15.6 (13.9–17.5) | 11.9 (10.5–13.6) | 15.6 (13.6–17.8) | 11.1 (9.5–12.9) | |
| HR (95% CI) | 0.77 (0.65–0.92) | 0.71 (0.58–0.87) | |||
| HF hospitalization or cardiovascular death | 0.45 | ||||
| n (%) | 284 (20.9) | 222 (16.9) | 211 (20.8) | 160 (15.1) | |
| Event rate per 100 person‐years (95% CI) | 15.2 (13.6–17.1) | 11.9 (10.4–13.5) | 15.4 (13.4–17.6) | 10.9 (9.3–12.7) | |
| HR (95% CI) | 0.78 (0.65–0.93) | 0.70 (0.57–0.86) | |||
| HF hospitalization | 0.73 | ||||
| n (%) | 173 (12.7) | 118 (9.0) | 145 (14.3) | 113 (10.7) | |
| Event rate per 100 person‐years (95% CI) | 9.3 (8.0–10.8) | 6.3 (5.3–7.6) | 10.6 (9.0–12.4) | 7.7 (6.4–9.2) | |
| HR (95% CI) | 0.68 (0.54–0.86) | 0.72 (0.57–0.92) | |||
| Cardiovascular death | 0.13 | ||||
| n (%) | 170 (12.5) | 152 (11.6) | 103 (10.2) | 75 (7.1) | |
| Event rate per 100 person‐years (95% CI) | 8.6 (7.4–10.0) | 7.8 (6.7–9.2) | 7.0 (5.8–8.5) | 4.8 (3.9–6.1) | |
| HR (95% CI) | 0.92 (0.74–1.14) | 0.69 (0.51–0.93) | |||
| All‐cause death | 0.10 | ||||
| n (%) | 206 (15.2) | 185 (14.1) | 123 (12.1) | 91 (8.6) | |
| Event rate per 100 person‐years (95% CI) | 10.4 (9.1–11.9) | 9.5 (8.3–11.0) | 8.4 (7.0–10.0) | 5.9 (4.8–7.2) | |
| HR (95% CI) | 0.92 (0.76–1.12) | 0.70 (0.53–0.92) | |||
| Recurrent HF hospitalization or cardiovascular death | 0.19 | ||||
| No. of events | 407 | 328 | 335 | 239 | |
| RR (95% CI) | 0.82 (0.68–1.00) | 0.67 (0.53–0.85) | |||
| KCCQ‐TSS | |||||
| Change in KCCQ‐TSS score at 8 months | 3.0 (1.9–4.0) | 6.5 (5.4–7.6) | 3.8 (2.4–5.1) | 5.6 (4.4–6.9) | 0.40 |
| ≥5‐point improvement in KCCQ‐TSS at 8 months | 0.32 | ||||
| Proportion of patients | 49.5% | 58.3% | 52.9% | 58.3% | |
| OR (95% CI) | 1.19 (1.09–1.29) | 1.11 (1.01–1.22) | |||
| ≥5‐point decrease in KCCQ‐TSS at 8 months | 0.76 | ||||
| Proportion of patients | 33.3% | 25.2% | 32.3% | 25.5% | |
| OR (95% CI) | 0.83 (0.76–0.90) | 0.85 (0.76–0.94) | |||
CI, confidence interval; HF, heart failure; HR, hazard ratio; KCCQ‐TSS, Kansas City Cardiomyopathy Questionnaire total symptom score; OR, odds ratio; RR, rate ratio.