Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction - DAPA-HF

Contribution To Literature:

The DAPA-HF trial showed that dapagliflozin was superior to placebo at preventing cardiovascular deaths and heart failure events.


The goal of the trial was to evaluate dapagliflozin (a sodium-glucose cotransporter 2 [SGLT2] inhibitor) compared with placebo among patients with heart failure with reduced ejection fraction (HFrEF).

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients with HFrEF (irrespective of diabetes status) were randomized to dapagliflozin 10 mg daily (n = 2,373) versus placebo (n = 2,371).

  • Total number of enrollees: 4,744
  • Duration of follow-up: 18.2 months
  • Mean patient age: 66 years
  • Percentage female: 24%
  • Percentage with diabetes: 42%

Inclusion criteria:

  • Symptomatic heart failure
  • Left ventricular ejection fraction (LVEF) ≤40%
  • N-terminal pro–B-type natriuretic peptide ≥600 pg/ml (if hospitalized for heart failure within last 12 months ≥400 pg/ml; if atrial fibrillation/flutter ≥900 pg/ml)

Exclusion criteria:

  • Estimated glomerular filtration rate <30 ml/min/1.73 m2
  • Symptomatic hypotension or systolic blood pressure <95 mm Hg
  • Type 1 diabetes mellitus

Principal Findings:

The primary outcome of cardiovascular death, hospitalization for heart failure, or urgent heart failure visit occurred in 16.3% of the dapagliflozin group compared with 21.2% of the placebo group (p < 0.001). The primary outcome was the same in prespecified subgroups, including according to diabetes status.

Secondary outcomes:

  • Cardiovascular death: 9.6% with dapagliflozin vs. 11.5% with placebo
  • Hospitalization for heart failure: 9.7% with dapagliflozin vs. 13.4% with placebo
  • Worsening of renal function: 1.2% with dapagliflozin vs. 1.6% with placebo (p = 0.17)


Among patients with symptomatic HFrEF, dapagliflozin was beneficial. Dapagliflozin vs. placebo was associated with a reduction in cardiovascular deaths and heart failure events. There was no sign of adverse safety events. The baseline use of sacubitril-valsartan was low. Dapagliflozin may signal a new approach in the treatment of patients with HFrEF.


McMurray JJ, Solomon SD, Inzucchi SE, et al., on behalf of the DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients With Heart Failure and Reduced Ejection Fraction. N Engl J Med 2019;Sep 19:[Epub ahead of print].

Editorial: Heart-Failure Therapy — New Drugs but Old Habits? N Engl J Med 2019;Sep 19:[Epub ahead of print].

Presented by Dr. John McMurray at the European Society of Cardiology Congress, Paris, France, September 1, 2019.

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Clinical Topics: Anticoagulation Management, Dyslipidemia, Heart Failure and Cardiomyopathies, Lipid Metabolism, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: ESC Congress, ESC 19, Benzhydryl Compounds, Glomerular Filtration Rate, Glucosides, Heart Failure, Hospitalization, Hypotension, Natriuretic Peptide, Brain, Peptide Fragments, Renal Insufficiency, Sodium-Glucose Transporter 2, Stroke Volume

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