Boehringer reports additional Pradaxa data

Boehringer Ingelheim GmbH (Ingelheim, Germany) reported data from a pair of Phase III trials on Wednesday evaluating Pradaxa dabigatran etexilate to prevent recurrent venous thromboembolism (VTE). In the Phase III RE-MEDY trial in 2,856 VTE patients, extended treatment with Pradaxa for 6-36 months 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). Pradaxa also significantly reduced the rate of major or clinically relevant bleeding vs. warfarin (5.6% vs. 10.2%, p<0.001).

In the Phase III RE-SONATE trial in 1,343 VTE patients, extended treatment with Pradaxa for six months met the primary endpoint of preventing recurrent or fatal VTE vs. placebo (0.4% vs. 5.6%, p<0.001). Pradaxa significantly increased the rate of major or clinically relevant bleeding vs. placebo (5.3% vs. 1.8%, p=0.001). Both trials enrolled patients who had received at least three months of therapy with Pradaxa or an approved anticoagulant. Patients in RE-MEDY were also considered to be at an increased risk for recurrent VTE. Data were published in the New England Journal of Medicine. ...