- Empagliflozin significantly reduced the risk for cardiovascular death or heart failure hospitalization in patients with chronic heart failure with reduced ejection fraction (HFrEF), regardless of diabetes status.
- Empagliflozin was also associated with a slower rate of decline in renal function.
Why this matters
- The 25% reduction in the risk for cardiovascular death or heart failure hospitalization with empagliflozin is comparable with that reported for dapagliflozin in the DAPA-HF trial.
- EMPEROR-Reduced trial: patients with class II, III, or IV heart failure and ejection fraction ≤40%, with or without diabetes, were randomly assigned to empagliflozin 10 mg once daily (n=1863) or placebo (n=1867).
- Primary endpoint was a composite of cardiovascular death or hospitalization for heart failure.
- Funding: Boehringer Ingelheim; Eli Lilly.
- During a median follow-up of 16 months, the primary endpoint was met in 19.4% of patients in the empagliflozin group vs 24.7% of patients in the placebo group (HR, 0.75; 95% CI, 0.65-0.86).
- The effect of empagliflozin on the primary outcome was consistent across patients:
- With diabetes: HR, 0.72 (95% CI, 0.60-0.87); and
- Without diabetes: HR, 0.78 (95% CI, 0.64-0.97).
- Total hospitalizations for heart failure were lower in the empagliflozin group than the placebo group (HR, 0.70; 95% CI, 0.58-0.85).
- The empagliflozin group had a slower annual rate of decline in the estimated glomerular filtration rate than the placebo group (–0.55 vs –2.28 mL/minute/1.73 m2 of body surface area/year; P<.001>
- Adverse renal outcomes occurred in 30 patients in the empagliflozin group and 58 patients in the placebo group (HR, 0.50; 95% CI, 0.32-0.77).
- Uncomplicated genitourinary tract infections were more frequent in the empagliflozin group than the placebo group.
Principal investigator, Milton Packer, MD: "The combined results of EMPEROR-Reduced together with DAPA-HF now establish SGLT2 inhibition with empagliflozin and dapagliflozin as a new cornerstone of the treatment of heart failure. The other three cornerstones are angiotensin receptor–neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists. Patients with HFrEF should be receiving all four drugs."