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ARTICLE | Clinical News

Pradaxa dabigatran etexilate: Phase III data

February 25, 2013 8:00 AM UTC

The double-blind, international Phase III RE-MEDY trial in 2,856 VTE patients who had received at least 3 months of therapy with Pradaxa or an approved anticoagulant and were considered to be at an increased risk for recurrent VTE showed that extended treatment for 6-36 months with twice-daily 150 mg Pradaxa met the primary endpoint of non-inferiority to warfarin in preventing recurrent or fatal VTE (1.8% vs. 1.3%, p=0.01 for non-inferiority). On secondary endpoints, there was no significant difference between Pradaxa and warfarin in the occurrence of symptomatic DVT (1.2% vs. 0.9%, p=0.46), symptomatic non-fatal PE (0.7% vs. 0.4%, p=0.19), VTE-related death (0.1% for both, p=0.99) and all deaths (1.2% vs. 1.3%, p=0.74). Pradaxa also significantly reduced the rate of major or clinically relevant bleeding vs. warfarin (5.6% vs. 10.2%, p<0.001), but non-significantly reduced the rate of major bleeding (0.9% vs. 1.8%, p=0.06). The rate of acute coronary syndrome (ACS) events during treatment was significantly higher in the Pradaxa group vs. warfarin (0.9% vs. 0.2%, p=0.02). Data were published in the New England Journal of Medicine. ...