INGELHEIM, Germany--(BUSINESS WIRE)--Nov 10, 2015--Boehringer Ingelheim announces results from two new analyses evaluating idarucizumab, recently approved under the Accelerated Approval pathway and marketed in the U. S. as Praxbind R, a specific reversal agent for Pradaxa R (dabigatran etexilate), that were presented at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando. 1,2 One analysis examined reinitiation of antithrombotic therapy after administration of idarucizumab. 1 The reinitiation of antithrombotic therapy in patients with nonvalvular atrial fibrillation (AF) is important in order to address the underlying risk of stroke.
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An interim analysis of data from the ongoing phase III RE-VERSE AD? trial showed reinitiation of alternative antithrombotic therapy was possible any time after idarucizumab use. Reinitiation of alternative antithrombotic therapy (e.g. heparin) after treatment with idarucizumab ranged from 0.2 days to 77.2 days in patients who presented with uncontrolled or life-threatening bleeding and 0 days to 40.8 days in patients requiring emergency surgery or an urgent procedure. Reinitiation of dabigatran after treatment with idarucizumab ranged from 1.3 days to 90.6 days in patients with uncontrolled or life-threatening bleeding, and 1 day to 63.31 days in patients requiring emergency surgery or an urgent procedure. 1
"Reinitiation of antithrombotic therapy as soon as medically appropriate should be considered to reduce the underlying stroke risk for patients with nonvalvular atrial fibrillation," said Charles Pollack, MD, Associate Provost and Professor of Emergency Medicine, Thomas Jefferson University in Philadelphia, and lead investigator of RE-VERSE AD?. "The findings from this interim analysis from the phase III RE-VERSE AD? study may provide physicians added insight into the reinitiation of antithrombotic therapy after dabigatran reversal in the rare emergency situations where administration of idarucizumab is deemed necessary."
A second presentation on idarucizumab included findings from an in vitro study investigating the efficacy of idarucizumab in the presence of coagulation factor concentrates [e.g., blood-clotting proteins recombinant Factor VIIa, 3- or 4-factor prothrombin complex concentrates (PCC), and activated PCC]. Results showed that the reversal effect of idarucizumab on dabigatran was not affected by the presence of coagulation factor concentrates. 2 This result is important as these agents are frequently used in the management of patients presenting with acute hemorrhages. The study also showed that the use of idarucizumab did not inhibit the anticoagulation effects of other commercially available blood thinners (direct factor Xa inhibitors, heparins, or other direct thrombin inhibitors).
"The findings from this interim analysis from the phase III RE-VERSE AD? trial suggest that idarucizumab may give physicians flexibility in managing antithrombotic therapy and greater control in making treatment decisions for patients taking dabigatran," said Professor Jorg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. "Although idarucizumab will be rarely used in clinical practice, a specific reversal agent may provide an important therapeutic option for physicians and patients."
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PUB: 11/10/2015 02:10 AM/DISC: 11/10/2015 02:10 AM