6/28/23, 1:15 AM DAPA-HF Pathway Feedback Search Clinical Topics Home Studies DAPA HF DAPA HF Disease Heart failure Trial question What is the role of dapagliflozin among patients with HFrEF? Study design Multi-center Double blinded RCT Population Characteristics of study participants 23.0% female N = 4744 77.0% male 4744 patients (1109 female, 3635 male) Inclusion criteria: adult patients with NYHA class II, III, or IV HF and an ejection fraction < 40% Key exclusion criteria: recent treatment with or unacceptable side effects associated with a sodium-glucose cotransporter 2 inhibitor, T1DM mellitus, symptoms of hypotension or a systolic BP < 95 mmHg Interventions N=2373 dapagliflozin (at a dose of 10 mg once daily, per oral use) N=2371 placebo (matching placebo daily) Primary outcome Worsening heart failure or cardiovascular death https://web.pathway.md/studies/recqOXHSgWAbkdUQE 1/2 6/28/23, 1:15 AM DAPA-HF Pathway 21.2 % 21.2 16.3 15.9 % 10.6 % Significant decrease 5.3 % NNT = 20 0.0 % Dapagliflozin Placebo Significant decrease in worsening HF or cardiovascular death (16.3% vs. 21.2%; HR 0.74, 95% CI 0.65 to 0.85) Secondary outcomes Significant decrease in hospitalization for HF or death from cardiovascular causes (16.1% vs. 20.9%; HR 0.75, 95% CI 0.65 to 0.85) Borderline significant decrease in a first worsening cardiovascular event (10% vs. 13.7%; HR 0.7, 95% CI 0.59 to 0.83) Borderline significant decrease in death from any cause (11.6% vs. 13.9%; HR 0.83, 95% CI 0.71 to 0.97) Safety outcomes No significant differences in adverse events including volume depletion, hypoglycemia, renal dysfunction. Significant difference in serious renal adverse events (1.6% vs. 2.7%). Conclusion In adult patients with NYHA class II, III, or IV HF and an ejection fraction < 40%, dapagliflozin was superior to placebo with respect to worsening HF or cardiovascular death. Reference John J V McMurray, Scott D Solomon, Silvio E Inzucchi et al. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. Open reference URL https://web.pathway.md/studies/recqOXHSgWAbkdUQE 2/2