Thrombotic events occurred in five patients between two to 24 days after idarucizumab administration. Normal blood clotting (hemostasis) during surgery was reported in 92 percent of patients (48/52). In Group B (n=52), the mean time to surgery was 1.7 hours following administration of idarucizumab. All patients received 5g of idarucizumab, and reversal was evident in all assessable patients (n=100).Īmong assessed patients in Group A (n=48), the median subjective investigator-reported time to cessation of bleeding was 9.8 hours. Patients were categorized into two groups – (A) patients with uncontrolled or life-threatening bleeding complications (Group A, n=66), or (B) patients requiring emergency surgery or an invasive procedure (Group B, n=57). RE-VERSE AD was designed to allow for the types of patients healthcare professionals may treat in real-world emergency settings. "We have enrolled patients in more than 35 countries and we look forward to the additional analyses and final results to further support the safety, effectiveness and impact of idarucizumab." Charles Pollack, lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University in Philadelphia.
"The data from this new RE-VERSE AD interim analysis, of the first 123 patients, support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care," said Dr. The results from this study were presented today at the American College of Cardiology 65 th Annual Scientific Session (ACC.16) and Expo in Chicago. Food and Drug Administration (FDA) in October 2015 and is marketed in the U.S. Idarucizumab was the first specific reversal agent for a novel oral anticoagulant approved by the U.S. today announced the results of a new interim analysis of data from the ongoing phase III RE-VERSE AD™ patient study that showed a single 5g dose of idarucizumab immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa ® (dabigatran etexilate mesylate) in all patients evaluated.
RIDGEFIELD, Conn., Ap/PRNewswire/ - Boehringer Ingelheim Pharmaceuticals, Inc.
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