The FDA has approved Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for  5–10 days, and to reduce the risk of recurrent DVT and PE in previously treated patients.

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This approval was based on results from four global Phase 3 trials evaluating dabigatran efficacy and safety in the treatment of DVT/PE. 

The RE-COVER and RE-COVER II trials randomized patients with DVT and PE to a 5–10 day treatment of parenteral anticoagulation followed by dabigatran or warfarin. Pradaxa was non-inferior to warfarin in reducing DVT and PE after a median of 174 days  of treatment and was associated with a lower rate of overall bleeding and a higher incidence of GI bleeding (3.1% vs. 2.4%). 

The RE-MEDY trial also demonstrated dabigatran to be non-inferior to warfarin after a median of 534 days treatment in patients previously given 3–12 months of anticoagulation for an acute DVT or PE.  Pradaxa was associated with lower rates of overall bleeding and a higher rate of any GI bleeding (3.1% vs. 2.2%).

The placebo-controlled RE-SONATE trial examined DVT/PE recurrence rate in patients anticoagulated for 6–18 months. After a median of 182 days, dabigatran reduced the risk of DVT and PE recurrence by 92% relative to placebo (0.4% vs. 5.6%, HR=0.08 [CI: 0.02, 0.25]). It was associated with higher rates of any bleeding (10.5% vs. 6.1%, HR=1.77 [CI: 1.20, 2.61]), clinically relevant non-major bleeding (5.0% vs. 2.0%, HR=2.54 [CI: 1.34, 4.82]), and GI bleeding (0.7% vs. 0.3%).

Pradaxa is an oral direct thrombin inhibitor already indicated for the reduction of stroke and systemic embolism risk in patients with non-valvular atrial fibrillation.  

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