Table 2: Heart failure outcomes and all-cause hospitalisation in the EMPA-REG OUTCOME study.
| Placebo (n=2,333) | Empagliflozin (n=4,687) | HR (95% CI) | p-value | |||
|---|---|---|---|---|---|---|
| n (%) | Rate/1,000 patient-years | n (%) | Rate/1,000 patient-years | |||
| Heart failure hospitalisation or CV death | 198 (8.5) | 30.1 | 265 (5.7) | 19.7 | 0.66 (0.55, 0.79) | <0.001 |
| Hospitalisation for death from heart failure | 104 (4.5) | 15.8 | 129 (2.8) | 9.6 | 0.61 (0.47, 0.79) | <0.001 |
| Hospitalisation 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 hospitalisation | 925 (39.6) | 183.3 | 1,725 (36.8) | 161.9 | 0.89 (0.82, 0.96) | 0.003 |
Reproduced with permission from Fitchett et al., 201634aBased on narrow standardised MedDRA query ‘cardiac failure’, 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. Parents treated with at least one dose of study drugs. CI = confidence interval; CV = cardiovascular; EMPA-REG OUTCOME = empagliflozin, cardiovascular outcomes and mortality in type 2 diabetes study; HR = hazard ratio; MedDRA = Medical Dictionary for Regulatory Activities.