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      Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal

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          Use of non-vitamin K antagonist oral anticoagulants is spreading in the real world. Despite that, a strong need for antidotes/reversal agents is still reported by several physicians. Idarucizumab is a humanized monoclonal antibody fragment that binds specifically to dabigatran. Idarucizumab was approved in 2015 by the US Food and Drugs Administration and European Medicines Agency for reversal of anticoagulation activity in dabigatrantreated patients. This review briefly summarizes the experimental evidence about effectiveness and safety of idarucizumab. Furthermore, we review the current recommendations and experts’ point of view about the use of antidotes/reversal agents in patients reporting a major bleeding event.

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          Most cited references 13

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          Idarucizumab for Dabigatran Reversal - Full Cohort Analysis.

          Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran.
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            2017 ACC Expert Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants

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              Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran.

              Idarucizumab, a Fab fragment directed against dabigatran, produced rapid and complete reversal of the anticoagulation effect of dabigatran in animals and in healthy volunteers. The Study of the REVERSal Effects of Idarucizumab in Patients on Active Dabigatran (RE-VERSE AD™) is a global phase 3 prospective cohort study aimed at investigating idarucizumab in dabigatran-treated patients who present with uncontrollable or life-threatening bleeding, and in those requiring urgent surgery or intervention. We describe the rationale for, and design of the trial (clinicaltrials.gov NCT02104947).

                Author and article information

                Ther Clin Risk Manag
                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                Therapeutics and Clinical Risk Management
                Dove Medical Press
                22 August 2018
                : 14
                : 1483-1488
                [1 ]Department of Neuroscience, I Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy
                [2 ]Institute of Cardiovascular Sciences, Universit of Birmingham, Birmingham, UK
                [3 ]Department of Internal Medicine and Medical Specialties, Sapienza-University of Rome, Rome, Italy
                [4 ]Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy, giuseppe.boriani@ 123456unimore.it
                Author notes
                Correspondence: Giuseppe Boriani, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Via del Pozzo, 71, 41124 Modena, Italy, Tel +39 59 422 5836, Fax +39 9 422 4498, Email giuseppe.boriani@ 123456unimore.it
                © 2018 Proietti and Boriani. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.



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