What is the role of dabigatran (Pradaxa) in the treatment of deep venous thrombosis (DVT)?

Updated: Jun 05, 2019
  • Author: Kaushal (Kevin) Patel, MD; Chief Editor: Barry E Brenner, MD, PhD, FACEP  more...
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Answer

Dabigatran (Pradaxa) inhibits free and clot-bound thrombin and thrombin-induced platelet aggregation. This agent was FDA approved in 2010 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. In April 2014, it was approved for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5-10 days. Additionally, it was approved to reduce the risk of DVT and PE recurrence in patients who have been previously treated. Approval was based on results from 4 global phase III trials that showed dabigatran was noninferior to warfarin and had a lower risk of major or clinically relevant bleeding compared with warfarin. [128, 129, 130] There have been reports of severe and fatal bleeding in users of the drug.


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