Table 1.
Heart failure outcomes and all-cause hospitalization
| Outcome | Placebo (N = 2333) |
Empagliflozin (N = 4687) |
HR (95% CI) | P-value | ||
|---|---|---|---|---|---|---|
| n (%) | Rate/1000 patient-years | n (%) | Rate/1000 patient-years | |||
| Heart failure hospitalization or cardiovascular death | 198 (8.5) | 30.1 | 265 (5.7) | 19.7 | 0.66 (0.55–0.79) | <0.001 |
| Hospitalization for or death from heart failure | 104 (4.5) | 15.8 | 129 (2.8) | 9.6 | 0.61 (0.47–0.79) | <0.001 |
| Hospitalization for heart failure | 95 (4.1) | 14.5 | 126 (2.7) | 9.4 | 0.65 (0.50–0.85) | 0.002 |
| Investigator-reported heart failurea | 143 (6.1) | 22.0 | 204 (4.4) | 15.3 | 0.70 (0.56–0.87) | 0.001 |
| Investigator-reported serious heart failurea,b | 136 (5.8) | 20.9 | 192 (4.1) | 14.4 | 0.69 (0.55–0.86) | 0.001 |
| All-cause hospitalization | 925 (39.6) | 183.3 | 1725 (36.8) | 161.9 | 0.89 (0.82–0.96) | 0.003 |
CI, confidence interval; HR, hazard ratio; MedDRA, Medical Dictionary for Regulatory Activities.
aBased on narrow standardized MedDRA query ‘cardiac failure’, which comprised these preferred terms: acute pulmonary oedema; cardiac failure; cardiac failure, acute; cardiac failure, chronic; cardiac failure, congestive; cardiogenic shock; cardiopulmonary failure; left ventricular failure; pulmonary oedema; right ventricular failure.
bAdverse events reported as serious adverse events by investigator. Patients treated with at least one dose of study drug.