× Key messages Background DAPA-HF update Conclusions Expert commentary
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DAPA-HF update

Main cardiovascular outcomes

  • 4744 patients with NYHA class II, III, or IV heart failure and an ejection fraction (EF) of 40% or less were randomized to receive either dapagliflozin or placebo, in addition to recommended therapy.
  • The primary outcome was a composite of worsening HF (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or CV death.
  • Among patients with HF and a reduced EF, the risk of worsening HF or death from CV causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes.
  • Dapagliflozin was also associated with reduced all-cause mortality vs. placebo.
  • No differences were seen in composite renal outcome, perhaps due to the small number of events.
  • Based on these and other results, dapagliflozin was approved by the Food and Drug Administration in May 2020 for treatment of HF with reduced EF.

Patient-centered outcomes

  • The Kansas City Cardiomyopathy Questionnaire (KCCQ) was used to study patient-centered outcomes with dapagliflozin in DAPA-HF.
  • Dapagliflozin was favored over placebo for the primary endpoint in all KCCQ quartiles.
  • Dapagliflozin was also associated with KCCQ total symptom score improvement as well as clinically meaningful improvements in all key domains of the KCCQ.
  • Dapagliflozin improved all major components of the KCCQ, with effects that were amplified over time.
  • Fewer patients treated with dapagliflozin showed significant deterioration, and more experienced small, moderate, and large clinically meaningful improvements across all key domains of KCCQ.
  • The effects were substantial, the number needed to treat ranging from 12-18 vs. placebo after 8 months of treatment.

Metabolic outcomes, diabetes prevention, and safety

  • HbA1c levels were similar between groups in patients with prediabetes or who were normoglycemic.
  • Higher body mass index, HbA1c, and lower estimated glomerular filtration rate were all associated with a greater risk of new onset type 2 diabetes (T2D).
  • The incidence of new onset T2D was significantly lower with dapagliflozin vs. placebo.
  • Dapagliflozin reduced the incidence of T2D by 32% in the 2605 participants in the DAPA-HF trial without T2D at baseline.
  • The effect was principally driven by participants with prediabetes.
  • Patients with new onset T2D had greater mortality.