Joshua B Darnell and Erika L Kleppinger

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Objective: To review, analyze, and critique dabigatran etexilate’s approved uses as an anticoagulant.

Data Sources: Literature searches were performed via MEDLINE, International Pharmaceutical Abstracts, and Google Scholar through February 2011, using the term dabigatran. Additional data were obtained from tertiary sources and prescribing information.

Study Selection and Data Extraction: All published Phase 3 anticoagulation trials investigating dabigatran for currently approved indications were selected. Information from other anticoagulation trials investigating dabigatran was used for critiquing Phase 3 studies.

Data Synthesis: Dabigatran etexilate has been evaluated in multiple clinical trials as an alternative to enoxaparin for prevention of venous thromboembolism in total hip and knee replacement surgeries. It has also been evaluated as an alternative to warfarin in stroke and systemic embolism prevention in patients with atrial fibrillation. Results have generally been positive, with few exceptions. The standard adult dose of dabigatran 150 mg twice daily, approved for use in the US for stroke prevention in nonvalvular atrial fibrillation, was found to be superior to warfarin in regard to occurrence rates of stroke or systemic embolism and hemorrhagic stroke. The occurrence rates of intracranial bleeding, life-threatening bleeding, and major or minor bleeding were lower with dabigatran 150 mg twice daily than with warfarin; however, the occurrence of gastrointestinal bleeding was significantly higher.

CONCLUSIONS: With its numerous benefits, and despite its drawbacks, dabigatran remains a promising option for oral anticoagulation therapy

J Pharm Technol 2011;27:258-65.