What is the role of dabigatran (Pradaxa) in initial anticoagulation therapy for deep venous thrombosis (DVT)?

Updated: Nov 09, 2018
  • Author: Donald Schreiber, MD, CM; Chief Editor: Barry E Brenner, MD, PhD, FACEP  more...
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Answer

Answer

Dabigatran (Pradaxa) inhibits free and clot-bound thrombin and thrombin-induced platelet aggregation. It was FDA approved in 2010 to reduce the risk of stroke in patients with NVAF. In April 2014, the FDA approved it for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5-10 days. In addition, 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 four 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. [22, 23, 24] There have been reports of severe and fatal bleeding in users of the drug.

The RE-COVER and RE-COVER II trials included patients with DVT and PE who were treated with parenteral anticoagulant therapy for 5-10 days. Results showed dabigatran was noninferior to warfarin in reducing DVT and PE after a median of 174 days of treatment with a lower risk of bleeding compared with warfarin. [22, 23]

The RE-SONATE trial and RE-MEDY trials included 2856 patients with acute DVT and PE who had completed at least 3 months of anticoagulant therapy. Results from this trial showed dabigatran was noninferior to warfarin in the extended treatment of VTE and carried a lower risk of major or clinically relevant bleeding than warfarin. [24]


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