Two trials demonstrate benefits of Pradaxa/Rendix (Boehringer) for patients with VTE

New findings from two double-blind, randomized trials, RE-MEDYSM and RE-SONATE, show that Pradaxa/Rendix (dabigatran etexilate), from Boehringer, reduces the risk of recurrent Venous ThromboEmbolism (VTE). RE-MEDY demonstrated that treatment with dabigatran 150 mg twice daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, including VTE-related death. RE-SONATE demonstrated dabigatran was superior to placebo for the prevention of first recurrent or fatal VTE with a risk reduction of 92 percent during the treatment period (p<0.001). lower event rates were reported across all secondary efficacy endpoints for dabigatran over placebo. there were fewer major bleeding events in patients with a prior history of vte receiving dabigatran compared with those receiving warfarin.>

There was also a significantly lower risk (46 percent) of major or clinically relevant bleeding events in this same set of patients. Data was published in the New England Journal of Medicine. See: "Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism." Sam Schulman et al. N Engl J Med 2013; 368:709-718February 21, 2013DOI: 10.1056/NEJMoa1113697