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Keywords:

  • cardiovascular;
  • clinical pharmacology;
  • clinical research;
  • clinical trials;
  • hematology;
  • pharmacology

Abstract

Dabigatran etexilate is an oral prodrug of dabigatran, a direct thrombin inhibitor, that provides the first available oral anticoagulant alternative to warfarin for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). Although warfarin is effective, many patients with AF remain undertreated, primarily because of the management challenges associated with warfarin therapy. Dabigatran etexilate offers several potential advantages over warfarin, including fixed dosing, no requirement for blood coagulation monitoring, and reduced propensity for drug-drug interactions. In a large phase 3 trial in patients with nonvalvular AF, the US Food and Drug Administration (FDA)–approved dose of dabigatran etexilate (150 mg twice daily [bid]) was superior to warfarin for prevention of stroke and systemic embolism; major bleeding rates were similar. The most notable side effects of dabigatran etexilate are dyspepsia and gastrointestinal bleeding. This review summarizes the clinical pharmacology and treatment considerations for dabigatran etexilate.