Pradaxa Reversal Agent Works Within Minutes in Phase 3 Study

Boehringer Ingelheim announced results from an interim analysis of the Phase 3 RE-VERSE AD patient study with idarucizumab for urgent reversal of the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).

RE-VERSE AD is designed to evaluate the types of patients and real-world situations healthcare professionals may see in the emergency setting. Patients were categorized into either patients with uncontrolled or life-threatening bleeding complications (eg, intracranial hemorrhage or severe trauma after a car accident [Group A, n= 51]), or patients requiring emergency surgery or an invasive procedure (eg, surgery for an open fracture after a fall [Group B, n=39]). The primary endpoint of the study is the degree of reversal of the anticoagulant effect of dabigatran achieved by idarucizumab 5g within four hours measured by diluted thrombin time (dTT) and ecarin clotting time (ECT).

The interim analysis from RE-VERSE AD included data from 90 patients in the emergency setting who were taking dabigatran and required reversal. Of the 81 patients that presented with elevated anticoagulation levels at baseline as measured with ECT, results showed that the study met its primary endpoint, achieving 100% maximum reversal as median value across all patients. Reversal was evident immediately after administration of the first vial of idarucizumab and was complete in all but one patient. After four and 12 hours, laboratory tests showed normal coagulation levels in almost 90% of patients. Normal blood clotting during surgery was reported in 92% of the patients that required surgery or invasive procedures.

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