Positive trial data on Pradaxa in NVAF published in Circulation-Boehringer

An FDA study of more than 134,000 patients found that Pradaxa (dabigatran etexilate mesylate), from Boehringer, was associated with significantly reduced risks of ischemic stroke, intracranial hemorrhage and death, and a significantly increased risk of major gastrointestinal hemorrhage, compared with warfarin in patients with non-valvular Atrial Fibrillation (NVAF). The study found no difference in major bleeds or myocardial infarction with PRADAXA compared to warfarin. The study, which was published online in Circulation on October 30, 2014, further reinforces the favorable benefit/risk profile of Pradaxa, as shown in the pivotal RE-LY trial for stroke risk reduction in NVAF.

The primary outcomes were a 20 percent reduced risk of ischemic stroke (205 vs. 270 events), with no difference in major hemorrhage (777 vs. 851 events). In addition, it showed a 66 percent reduced risk of intracranial hemorrhage (60 vs. 186 events), but a 28 percent increased risk of gastrointestinal bleeding (623 vs. 513 events). There were no differences in acute myocardial infarction (285 vs. 327 events). The study also found the following secondary outcomes: a 14 percent reduced risk of mortality and no difference in all hospitalized bleeds. See: "Cardiovascular, Bleeding, and Mortality Risks in Elderly Medicare Patients Treated with Dabigatran or Warfarin for Non-Valvular Atrial Fibrillation." David J. Graham et al. Circulation published on October 30 2014 doi:10.1161/CIRCULATIONAHA.114.012061