What is the role of dabigatran in the treatment of venous thromboembolism (VTE)?

Updated: Nov 05, 2020
  • Author: Vera A De Palo, MD, MBA, FCCP; Chief Editor: Vinod K Panchbhavi, MD, FACS  more...
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Answer

Dabigatran inhibits free and clot-bound thrombin and thrombin-induced platelet aggregation. It was approved in 2010 to reduce the risk of stroke 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.

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. [45, 46]

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 showed that dabigatran was noninferior to warfarin in the extended treatment of VTE and carried a lower risk of major or clinically relevant bleeding than warfarin did. [47]


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