Table 2.
Effect of empagliflozin versus placebo on outcomes by baseline anaemia status (using haematocrit a )
| Outcome | Placebo | Empagliflozin | HR (95% CI) | Interaction p‐value | ||
|---|---|---|---|---|---|---|
| Events, n/N (%) | Event rate, per 100 py | Events, n/N (%) | Event rate, per 100 py | |||
| CV death or HFH | 0.59 | |||||
| No anaemia | 355/1511 (23.5) | 19.8 | 273/1502 (18.2) | 14.7 | 0.74 (0.63–0.86) | |
| Anaemia | 106/355 (29.9) | 26.3 | 88/358 (24.6) | 20.5 | 0.81 (0.61–1.07) | |
| Total HFH b | 0.93 | |||||
| No anaemia | 418 | – | 295 | – | 0.71 (0.57–0.88) | |
| Anaemia | 135 | – | 93 | – | 0.69 (0.45–1.05) | |
| Kidney composite c | 0.18 | |||||
| No anaemia | 36/1511 (2.4) | 2.4 | 23/1502 (1.5) | 1.5 | 0.62 (0.36–1.04) | |
| Anaemia | 22/355 (6.2) | 6.2 | 7/358 (2.0) | 1.9 | 0.31 (0.13–0.73) | |
| KCCQ‐TSS change week 52 d | 0.94 | |||||
| No anaemia | 5.2 (0.5) | – | 6.9 (0.5) | – | 1.7 (0.7) | |
| Anaemia | 5.0 (1.1) | – | 6.6 (1.1) | – | 1.6 (1.5) | |
| CV death | 0.96 | |||||
| No anaemia | 154/1511 (10.2) | 7.7 | 143/1502 (9.5) | 7.2 | 0.93 (0.74–1.17) | |
| Anaemia | 47/355 (13.2) | 10.0 | 44/358 (12.3) | 9.3 | 0.92 (0.61–1.39) | |
| All‐cause death | 0.48 | |||||
| No anaemia | 196/1511 (13.0) | 9.7 | 190/1502 (12.6) | 9.5 | 0.96 (0.79–1.17) | |
| Anaemia | 69/355 (19.4) | 14.7 | 59/358 (16.5) | 12.4 | 0.83 (0.59–1.18) | |
CI, confidence interval; CV, cardiovascular; eGFR, estimated glomerular filtration rate; HFH, hospitalization for heart failure; HR, hazard ratio; KCCQ‐TSS, Kansas City Cardiomyopathy Questionnaire total symptom score; py, patient‐years.
Anaemia defined by haematocrit <39% in men or <36% in women.
Total number of events, i.e. first and recurrent heart failure hospitalizations analysed by a joint frailty model.
Composite of sustained worsening kidney function ≥40% from baseline (sustained means in two consecutive visits separated by a minimum of 30 days), or end‐stage kidney disease (renal transplant, sustained eGFR <15 ml/min/1.73 m2 for patients with baseline eGFR ≥30 ml/min/1.73 m2 or eGFR <10 ml/min/1.73 m2 for patients with baseline eGFR <30 ml/min/1.73 m2 or chronic dialysis).
Mixed model for repeated measures with results presented as adjusted mean (standard error) for the change in KCCQ‐TSS points from baseline to week 52.