15 Apr Idarucizumab– PRAXBIND Reverses Anticoagulant Effects of Dabigatran
MedicalResearch.com Interview with:
Dr. Charles Pollack MD MA
Thomas Jefferson University
Philadelphia, PA 19107
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Pollack:: We are continuing research on PRAXBIND in the ongoing global phase III patient study, RE-VERSE AD™. RE-VERSE AD includes two groups of dabigatran patients: those who had serious bleeding or those who required an urgent procedure.
At ACC, we presented results from an updated interim analysis from 123 patients enrolled in RE-VERSE AD™, which showed a single 5g of PRAXBIND immediately reversed the anticoagulant effect of dabigatran in all patients evaluated.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Pollack: The study reinforces that PRAXBIND immediately reverses the anticoagulant effect of dabigatran in emergency situations. This implies that reversal of dabigatran by idarucizumab can enable the physician to proceed to urgent surgery without delay or to restore adequate hemostasis in anticoagulated patients with severe bleeding.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Pollack: The RE-VERSE AD study will be completed with around 500 patients. A number of secondary analyses can be performed on this larger dataset, such as the healthcare resource utilization impact of using PRAXBIND, the utility of some blood tests in assessing the activity of PRADAXA and PRAXBIND, and more detailed outcomes of complicated patients such as those with stroke and surgical procedures with high bleeding risk.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Pollack: The introduction of new treatment approaches such as specific reversal agents – as well as continued research – signals an important advancement in anticoagulation care. We’re continuing to deepen our understanding of patient needs and key attributes of emerging therapeutic options so that as physicians, we can be quickly responsive to them and best support each patient’s journey with anticoagulation care.
Abstracts presented at the 2016 ACC conference
Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Patients in an Emergency Setting of Major Bleeding, Urgent Surgery, or Interventions
Idarucizumab for Dabigatran Reversal
Charles V. Pollack, Jr., M.D., Paul A. Reilly, Ph.D., John Eikelboom, M.B., B.S., Stephan Glund, Ph.D., Peter Verhamme, M.D., Richard A. Bernstein, M.D., Ph.D., Robert Dubiel, Pharm.D., Menno V. Huisman, M.D., Ph.D., Elaine M. Hylek, M.D., Pieter W. Kamphuisen, M.D., Ph.D., Jörg Kreuzer, M.D., Jerrold H. Levy, M.D., Frank W. Sellke, M.D., Joachim Stangier, Ph.D., Thorsten Steiner, M.D., M.M.E., Bushi Wang, Ph.D., Chak-Wah Kam, M.D., and Jeffrey I. Weitz, M.D.
N Engl J Med 2015; 373:511-520
August 6, 2015 DOI: 10.1056/NEJMoa1502000