Edoxaban vs warfarin in patients with nonvalvular atrial fibrillation in the US Food and Drug Administration approval population: An analysis from the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial.

Journal: American heart journal
PMID: 26856226

Abstract

BACKGROUND: Edoxaban is a specific anti-Xa inhibitor that, in comparison to warfarin, has been found to be noninferior for the prevention of stroke or systemic embolism (SSE) and to reduce bleeding significantly in patients with nonvalvular atrial fibrillation (AF). The US Food and Drug Administration (FDA) approved the higher-dose edoxaban regimen (60/30 mg) in patients with AF and a creatinine clearance of ≤95 mL/min. We report for the first time the clinical characteristics, efficacy, and safety of the FDA-approved population in the ENGAGE AF--TIMI 48 trial.

Authors

  • Alon Eisen
    TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.
  • Robert P Giugliano
    TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.
  • Christian T Ruff
    TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.
  • Francesco Nordio
    TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.
  • Harinder S Gogia
    Anaheim Regional Medical Center, Anaheim, CA.
  • Vivek R Awasty
    Marion General Hospital, Marion, OH.
  • David A Henderson
    Florida Hospital Memorial Medical Center, Daytona Beach, FL.
  • Michele F Mercuri
    Daiichi Sankyo Pharma Development, Edison, NJ.
  • Howard Rutman
    Daiichi Sankyo Inc, Parsippany, NJ.
  • Elliott M Antman
    TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA.
  • Eugene Braunwald
    TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Department of Medicine, Harvard Medical School, Boston, MA. Electronic address: ebraunwald@partners.org.

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