Heart failure: dapagliflozin trial results in NEJM

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.