Heart failure: dapagliflozin trial results in NEJM

  • McMurray JJV & al.
  • N Engl J Med
  • 21 Nov 2019

  • International Clinical Digest
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Takeaway

  • Dapagliflozin for heart failure (HF) with reduced ejection fraction is tied to reduced risk for HF worsening or cardiovascular death, with or without diabetes.
  • The findings, published in NEJM, are the finalised trial results presented initially at the ESC 2019 meeting to spontaneous applause.

Why this matters

  • The sodium-glucose co-transporter 2 (SGLT2) inhibitor has already been linked to reduced HF hospitalisation risk in patients with diabetes.

Key results

  • 16.3% taking dapagliflozin vs 21.2% taking placebo had the composite primary outcome of worsening HF or cardiovascular death.
    • HR, 0.74 (95% CI, 0.65-0.85).
  • Separately, 10.0% taking dapagliflozin vs 13.7% taking placebo had a worsening HF event.
    • HR, 0.70 (95% CI, 0.59-0.83).
  • Cardiovascular death occurred in 9.6% taking dapagliflozin vs 11.5% taking placebo.
    • HR, 0.82 (95% CI, 0.69-0.98).
  • Any-cause death occurred in 11.6% taking dapagliflozin vs 13.9% taking placebo.
    • HR, 0.83 (95% CI, 0.71-0.97).
  • Findings were similar between patients with and without diabetes.
  • Adverse event frequency was similar between the groups.

Study design

  • Phase 3, placebo-controlled trial including 4744 participants with HF, ejection fraction ≤40%.
  • Drug dose, 10 mg/day.
  • Just under half of the patients in each group had diabetes.
  • Funding: AstraZeneca.

Limitations

  • Generalisability of selected clinical trial population results not known.
  • Few black participants.

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