Prescribing update to Pradaxa (Boehringer) for Stroke Prevention (AF) patients - 07-Jun-2012

Prescribing information for Pradaxa (dabigatran etexilate) capsules, from Boehringer, has been updated to affirm that "Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin." The update to the Clinical Studies section is based on the results of the pivotal RE-LY trial conducted in 18,000 patients with non-valvular atrial fibrillation (NVAF). In the RE-LY trial, Pradaxa 150mg twice daily was superior in reducing ischemic and hemorrhagic stroke compared to warfarin in patients with NVAF. The risk of major bleeds was similar with Pradaxa 150mg and warfarin across major subgroups with the exception of age, where there was a trend towards a higher incidence of major bleeding with Pradaxa for patients over 75 years of age. The company has recently launched Phase II of the GLORIA-AF patient registry, which is designed to better characterize the use of antithrombotic treatments to reduce the risk of stroke in patients with NVAF.