Boehringer Ingelheim presented results from two new analyses of data from the ongoing Phase 3 RE-VERSE AD trial evaluating idarucizumab, a specific reversal agent for Pradaxa (dabigatran etexilate), at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando, Florida.
One interim analysis showed that the reinitiation of alternative antithrombotic therapy (eg, heparin) was possible any time after idarucizumab treatment. Patients who presented with uncontrolled or life-threatening bleeding reinitiated 0.2 to 77.2 days after idarucizumab use, while patients requiring emergency surgery or an urgent procedure reinitiated 0 to 40.8 days after. Reinitiation of Pradaxa occurred 1.3 to 90.6 days after treatment with idarucizumab in patients with uncontrolled or life-threatening bleeding, and 1 to 63.31 days in patients requiring emergency surgery or an urgent procedure.
Findings from an in vitro study investigating the efficacy of idarucizumab in the presence of coagulation factor concentrates [eg, blood-clotting proteins recombinant Factor VIIa, 3- or 4-factor prothrombin complex concentrates (PCC), and activated PCC] were also presented. New data showed that the reversal effect of idarucizumab on Pradaxa was not affected by the presence of coagulation factor concentrates. In addition, it showed that idarucizumab use did not inhibit the anticoagulation effects of other commercially available blood thinners (direct factor Xa inhibitors, heparins, or other direct thrombin inhibitors).
Idarucizumab (Praxbind) was recently granted accelerated approval as a reversal agent for patients on Pradaxa during emergency situations.
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