The open label, randomized, multicenter, phase 2b/3 DIVERSITY trial evaluated the efficacy and safety of dabigatran compared with SOC (low molecular weight heparin or vitamin K antagonist) in 240 children.
The primary efficacy outcome was the combined rate of death from a cardiovascular cause, heart attack, stroke due to inadequate blood supply, blood clots or amputation due to cardiovascular disease.
The primary safety endpoint was defined as time to major bleeding events and clinically relevant non-major bleeding events when compared to triple therapy with warfarin.
Pollack, CV et al. "Idarucizumab for Dabigatran Reversal — Full Cohort Analysis." DOI: 10.1056/NEJMoa1707278
The data represents ~3,000 patients who had received the study drug in Phase 3 of GLORIA-AF with up to 2 years follow-up.
Boehringer Ingelheim has announced that Praxbind, a reversal agent for the oral anticoagulant Pradaxa (dabigatran etexilate mesylate), is now available in over 2,200 hospitals across the U.S
Idarucizumab (Praxbind) was recently granted accelerated approval as a reversal agent for patients on Pradaxa during emergency situations.
Appropriate patient selection and pharmacist-led monitoring were linked to greater adherence to dabigatran among patients with atrial fibrillation at Veterans Health Administration sites, according to a recent study published in JAMA.
Drugs in the Pipeline
Boehringer Ingelheim announced results from the RE-COVER II study evaluating dabigatran compared to warfarin in patients diagnosed with acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).
American College of Cardiology 2013
At ACC.13, the American College of Cardiology's 62nd Annual Scientific Session, Anil Rajendra, MD, from the Medical University of South Carolina, in Charleston, SC, presented data showing similar bleeding and thrombotic complication rates at the time of atrial fibrillation ablation (AFA) in patients anticoagulated with dabigatran and rivaroxaban. Dr. Rajendra and colleagues determined that rivaroxaban has an acceptable safety profile for AFA.