Pradaxa dabigatran etexilate: Additional Phase III data

Data from a subgroup analysis of 3,623 patients with a history of either stroke or transient ischemic attack in the international Phase III RE-LY trial showed that both doses of Pradaxa (110 and 150 mg) were non-inferior to warfarin on the primary endpoint of incidence of stroke or systemic embolism (2.32% and 2.07%, respectively, vs. 2.74%, p=0.37 and p=0.14). Low-dose Pradaxa led to significantly lower rates of major bleeding vs. warfarin (p=0.02), but high-dose Pradaxa did not (p=0.63). Furthermore, low- and high-dose Pradaxa led to significantly lower annual rates of hemorrhagic stroke vs. warfarin (0.08% and 0.2% vs. 0.77%, p=0.003 and p=0.009). Patients received blinded, twice-daily 110 or 150 mg Pradaxa or open-label, adjusted-dose warfarin for a median of 2 years. Data were presented at the International Stroke Conference in San Antonio. ...