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Clinical Summary

DAPA-HF: efficacy and safety of dapagliflozin according to LVEF

Takeaway

  • Left ventricular ejection fraction (LVEF) at baseline was a significant predictor of hospitalisation and mortality in patients with heart failure (HF) with reduced ejection fraction (HFrEF).
  • The beneficial effect of sodium-glucose co-transporter 2 inhibitor dapagliflozin on mortality/morbidity outcomes was not modified by LVEF in patients with HFrEF overall, and in those with and without diabetes separately.
Why this matters
  • A key question is whether the benefit of dapagliflozin will extend to patients with HF and mid-range/mildly reduced and preserved ejection fraction, especially in those without diabetes.

Study design

  • DAPA-HF was a phase 3, placebo-controlled trial involving 4744 patients with HF and LVEF ≤40%.
  • This post hoc analysis evaluated whether LVEF at baseline modified the effects of dapagliflozin in DAPA-HF.
  • LVEF categories analysed were: <26% (n=1143), 26-30% (n=1018), 31-35% (n=1187) and >35% (n=1396).
  • Primary outcome was a composite of a worsening HF (an unplanned hospitalisation for HF or an urgent HF visit requiring intravenous therapy) event or cardiovascular (CV) death.
  • Funding: AstraZeneca.
Key results
  • Mean LVEF was 31.1%.
  • In the overall cohort, each 5% decrease in LVEF was associated with a higher risk of the primary outcome (HR, 1.18; 95% CI, 1.13-1.24; P<.001).
  • The benefit of dapagliflozin over placebo for the primary composite outcome was consistent across the range of LVEF:
    • <26% (HR, 0.75; 95% CI, 0.59-0.95);
    • 26-30% (HR, 0.75; 95% CI, 0.57-0.98);
    • 31-35% (HR, 0.67; 95% CI, 0.51-0.89); and
    • >35% (HR, 0.83; 95% CI, 0.63-1.09; Pinteraction=.762).
  • Similarly, the effect of dapagliflozin on components of the primary outcome was consistent across the range of LVEF:
    • HF hospitalisation/urgent visit for HF (Pinteraction=.161); and
    • CV death (Pinteraction=.974).
  • The safety of dapagliflozin was consistent across the spectrum of LVEF and neither efficacy nor safety was modified by diabetes status.
Limitations
  • Post hoc analysis.
  • LVEF was measured using different methods at different sites.

References


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