Vericiguat yields reduced death, hospitalization with HFrEF

  • Armstrong PW & al.
  • N Engl J Med
  • 14 May 2020

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • For heart failure (HF) with reduced ejection fraction (HFrEF), vericiguat yields reductions in cardiovascular death and hospitalization among patients needing urgent care.
  • Number needed to treat was identified in this trial as about 24 patients.

Why this matters

  • These patients who have recent decompensated HF need treatment options that ameliorate a potentially poor prognosis.

Key results

  • Median follow-up, 10.8 months.
  • 35.5% of patients in the drug group vs 38.5% in placebo had the primary outcome of cardiovascular death or first HF hospitalization.
    • HR, 0.90 (95% CI, 0.82-0.98).
  • HF hospitalization rates were 27.4% with vericiguat vs 29.6% with placebo.
    • HR, 0.90 (95% CI, 0.81-1.00).
  • Cardiovascular death rates were 16.4% with the drug vs 17.5% with placebo.
    • HR, 0.93 (95% CI, 0.81-1.06).
  • Adverse events included symptomatic hypotension (9.1% drug vs 7.9% placebo) and syncope (4.0% drug vs 3.5% placebo) and did not differ significantly between groups.
  • Anemia was more common with drug vs placebo: 7.6% vs 5.7%.
    • 1.6% vs 0.9% were considered serious.

Study design

  • Phase 3 randomized, double-blind, placebo-controlled trial, enrolling 5050 patients from September 25, 2016 to December 21, 2018 at 616 sites in 42 countries.
  • Funding: MSD; Bayer.

Limitations

  • Role of vericiguat in those taking drugs for diabetes was not addressed.