Dabigatran Etexilate Capsules is a direct thrombin inhibitor indicated to reduce the risk of stroke and blood clots.
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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.
Efficacy similar to aspirin for preventing recurrent stroke after embolic stroke of undetermined source
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.
Researchers performed a retrospective cohort study to compare incidence of stroke, bleeding, and myocardial infarction in patients with atrial fibrillation initiating dabigatran or warfarin (n=25,289 for each) from November 2010 to May 2014.
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.
Effective for dabigatran reversal among patients with uncontrolled bleeding, undergoing urgent surgery
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.
Combining dabigatran with certain statin medications could raise the odds for major hemorrhage in patients with atrial fibrillation, according to a study published online in CMAJ, the journal of the Canadian Medical Association.