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.
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For patients taking dabigatran, the risk of gastrointestinal bleeding (GIB) is reduced with use of gastroprotective agents.
Boehringer Ingelheim announced that it has submitted a Biologics License Application (BLA) to the FDA, requesting accelerated approval for the use of idarucizumab to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).
Boehringer Ingelheim presented positive results of its Phase 3 RE-VERSE AD study for idarucizumab as a reversal agent for the anticoagulant effect of Pradaxa (dabigatran) in patients needing emergency surgery or for life-threatening or uncontrolled bleeding events.
To investigate the association between DOAC use and PPI initiation, researchers used data from community pharmacies in the Netherlands from 2012-2016.
The researchers searched the U.S. Medicare database for NVAF patients 65 years of age and older who were newly prescribed one of the following medications: apixaban, dabigatran, rivaroxaban, or warfarin.
The FDA has accepted for review the sNDA for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).
Dabigatran 150mg was superior to warfarin and dabigatran 110mg was noninferior to warfarin for preventing stroke in patients with atrial fibrillation (AF) regardless of CHA2DS2-VASc scores, as shown by the results of a subgroup analysis of the RE-LY trial presented today at ACC.11, the American College of Cardiology’s 60th Annual Scientific Session.
Boehringer Ingelheim announced results from an interim analysis of the Phase 3 RE-VERSE AS patient study with idarucizumab for urgent reversal of the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).
Resuming any anticoagulant found safer than stopping the drugs in these cases