MedicalResearch.com Interview with:
Thomas Seck, M.D., vice president
Clinical Development and Medical Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This is a new subanalysis of the phase III RE-VERSE AD™ study, which evaluated the safety and efficacy of idarucizumab, marketed in the U.S. as Praxbind®, in reversing the anticoagulant effect of Pradaxa® (dabigatran etexilate mesylate). This data assessed idarucizumab in a subset of patients requiring an urgent procedure or emergency surgery.
The analysis found that idarucizumab rapidly and completely reversed the anticoagulant effect of dabigatran in approximately 98 percent of patients based on dTT. The median time between administration of idarucizumab and start of surgery was 1.7 hours for patients requiring abdominal procedures, 1.9 hours for orthopedic procedures, 1.4 hours for vascular procedures, 1.3 hours for drainage procedures and 1.2 hours for catheter procedures. Among these patients, periprocedural homeostasis was assessed as normal in more than 92 percent of patients, across all surgery types.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: This additional analysis confirms that idarucizumab immediately reverses the anticoagulant effect of Pradaxa in this sub-set of patients and provides further insights on the use of idarucizumab in patients with a need for urgent surgery or intervention. Boehringer Ingelheim is dedicated to providing additional insights to patients and healthcare providers through new analyses of RE-VERSE AD.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In addition to RE-VERSE AD, we continue to study idarucizumab through the RE-VECTO™ program, which evaluates usage patterns in the clinical practice setting. Data for RE-VECTO is captured through hospital pharmacies where idarucizumab is dispensed and includes information about the types of patients and situations in which idarucizumab was utilized.
MedicalResearch.com: Is there anything else you would like to add?
Response: Idarucizumab is the first and only specific reversal agent for a novel oral anticoagulant and is available at more than 3,000 institutions in the U.S. It is approved as a specific reversal agent for Pradaxa by the U.S. Food and Drug Administration (FDA) under accelerated approval for use in the event of emergency procedures or uncontrollable bleeding. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.
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Citation: AHA 2017 abstract
Abstract 15113: Idarucizumab in Dabigatran-Treated Patients Requiring Emergency Surgery or Intervention: Updated/Final Results From the RE-VERSE AD Study
Jerrold Levy, Frank Sellke, Paul A Reilly, Joanne VanRyn, Jörg Kreuzer, Jeffrey Weitz, Charles Pollack
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