MedicalResearch.com Interview with:
Dr. Charles Pollack MD
Professor of Emergency Medicine
Sidney Kimmel Medical College at
Thomas Jefferson University, Philadelphia.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: RE-VERSE AD™ is a multinational, open-label cohort Phase III trial studying the safety and efficacy of idarucizumab (PRAXBIND) to reverse the anticoagulant effects of dabigatran (PRADAXA) in patients with life-threatening or uncontrolled bleeding, or those who require emergency procedures.
It is the largest patient study investigating a reversal agent for a novel oral anticoagulant (NOAC) in real world emergency settings. At the American Heart Association’s Scientific Sessions 2016, we presented updated results from 494 patients participating in the ongoing study, showing that administration of 5g of idarucizumab immediately reversed the anticoagulant effect of dabigatran.
MedicalResearch.com: What should readers take away from your report?
Response: These results further support that, although idarucizumab is likely to be rarely used, a specific reversal agent provides an important therapeutic option for physicians and patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: RE-VERSE AD is the first study of its kind in patients and has been underway since May 2014, enrolling up to 500 patients in more than 35 countries. It is ongoing, and final data will be announced next year.
MedicalResearch.com: Is there anything else you would like to add?
Response: The availability of idarucizumab as a reversal agent for dabigatran is an important development in anticoagulation care. When making treatment decisions, physicians and their patients must weigh safety risks against the individual’s risk of stroke. Knowing there is an available NOAC with a specific reversal agent may offer healthcare providers, patients and caregivers added assurance in treatment decisions.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Idarucizumab For Dabigatran Reversal: Updated Results Of The Re-verse Ad Study
Charles V Pollack, Thomas Jefferson Univ, Philadelphia, PA; Paul A Reilly, Boehringer Ingelheim, Ridgefield, CT; Joanne van Ryn, Boehringer Ingelheim, Biberach, Germany; Stephan Glund, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany; Richard A Bernstein, Feinberg Sch of Med of Northwestern Univ, Chicago, IL; Robert Dubiel, Boehringer Ingelheim, Ridgefield, CT; Menno V Huisman, Leiden Univ Medical Ctr, Leiden, Netherlands; Elaine M Hylek, Boston Univ Sch of Med, Boston, MA; Pieter W Kamphuisen, Tergooi Hosp, Hilversum, Netherlands; Joerg Kreuzer, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; Jerrold H Levy, Duke Univ Sch of Med, Durham, NC; Frank W Sellke, Brown Medical Sch and Rhode Island Hosp, Providence, RI; Joachim Stangier, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany; Thorsten Steiner, Klinikum Frankfurt Höchst, Frankfurt, Germany; Bushi Wang, Boehringer Ingelheim, Ridgefield, CT; Chak-Wah Kam, Tuen Mun Hosp, Tuen Mun, Hong Kong; Jeffrey I Weitz, McMaster Univ and Thrombosis and Atherosclerosis Res Inst, Hamilton, ON, Canada
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