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