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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-SONATE trial in 1,343 VTE patients who had received at least 3 months of therapy with Pradaxa or an approved anticoagulant showed that extended treatment for 6 months with twice-daily 150 mg Pradaxa met the primary endpoint of preventing recurrent or fatal VTE vs. placebo (0.4% vs. 5.6%, p<0.001). On secondary endpoints, Pradaxa reduced the occurrence of symptomatic DVT (0.3% vs. 3.3%), symptomatic non-fatal PE (0.1% vs. 2.1%) and unexplained death (0% vs. 0.3%) vs. placebo. Pradaxa significantly increased the rate of major or clinically relevant bleeding vs. placebo (5.3% vs. 1.8%, p=0.001). Major bleeding occurred in 2 of 681 patients receiving Pradaxa vs. no patients receiving placebo (n=662). Data were published in the New England Journal of Medicine. ...