- Question
- Does dapagliflozin reduce the risk of worsening heart failure or cardiovascular death in patients with heart failure and reduced ejection fraction, with or without type 2 diabetes?
- Design
- Phase 3, randomized, placebo-controlled, quadruple-masked trial enrolling 4744 patients with 1:1 allocation. Median follow-up was 18.2 months.
- Population
- Patients with NYHA class II, III, or IV heart failure and an ejection fraction of 40% or less, receiving recommended therapy, with or without type 2 diabetes.
- Intervention
- Dapagliflozin 10 mg once daily, added to recommended therapy.
- Control
- Matching placebo, added to recommended therapy.
- Primary outcome
- Composite of worsening heart failure (hospitalization or an urgent visit requiring intravenous therapy) or death from cardiovascular causes.
- Results
- The primary outcome occurred in 386 of 2373 patients (16.3%) with dapagliflozin and 502 of 2371 (21.2%) with placebo (HR 0.74; 95% CI 0.65 to 0.85; P<0.001). All-cause death occurred in 11.6% vs. 13.9% (HR 0.83; 95% CI 0.71 to 0.97).
- Safety
- The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups.
- Conclusion
- In patients with heart failure and reduced ejection fraction, dapagliflozin lowered the risk of worsening heart failure or cardiovascular death compared with placebo, regardless of diabetes status.
- Why it matters
- It established SGLT2 inhibitors as a treatment option for heart failure with reduced ejection fraction beyond their use in diabetes, broadening the foundational therapeutic toolkit.
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