- Question
- Does empagliflozin, added to recommended therapy, reduce cardiovascular death or hospitalization for heart failure in patients with heart failure and reduced ejection fraction, with or without diabetes?
- Design
- Randomized, double-blind, placebo-controlled phase III trial of 3730 patients with a median follow-up of 16 months.
- Population
- Patients with class II, III, or IV heart failure and an ejection fraction of 40% or less who were receiving recommended heart failure therapy.
- Intervention
- Empagliflozin 10 mg once daily, in addition to recommended therapy.
- Control
- Placebo, in addition to recommended therapy.
- Primary outcome
- Composite of cardiovascular death or hospitalization for worsening heart failure (time to first event).
- Results
- The primary outcome occurred in 361 of 1863 patients (19.4%) with empagliflozin and 462 of 1867 (24.7%) with placebo (HR 0.75; 95% CI 0.65 to 0.86; P<0.001), with a consistent effect in patients with and without diabetes. Total heart failure hospitalizations were lower with empagliflozin (HR 0.70; 95% CI 0.58 to 0.85; P<0.001).
- Safety
- Uncomplicated genital tract infection was reported more often with empagliflozin. The annual decline in estimated glomerular filtration rate was slower with empagliflozin (-0.55 vs. -2.28 ml/min/1.73 m2 per year), with a lower risk of serious renal outcomes.
- Conclusion
- In patients with heart failure and reduced ejection fraction receiving recommended therapy, empagliflozin lowered the risk of cardiovascular death or heart failure hospitalization regardless of diabetes status.
- Why it matters
- It showed that an SGLT2 inhibitor adds clinical benefit on top of standard therapy in heart failure with reduced ejection fraction, including in patients without diabetes, and helped establish this drug class as part of foundational treatment.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 7, 2026