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      Reversal agents for NOACs: Connecting the dots

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          Abstract

          Objective

          The objective of this review is to provide an overview on the current development of the specific reversal agents for Non-vitamin K Oral Anticoagulants (NOACs).

          Methods

          We conducted a systematic literature search strategy to identify potential studies on Medline, Embase, and the Cochrane register.

          Conclusions

          These new reversal agents for NOACs, will help address the unmet need for the management of major or life threatening bleeds, and the management of emergency surgical procedures in patients taking NOACs. It will increase confidence in the use of NOACs; thereby extending treatment to a wider range of patients.

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          Most cited references14

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          Systematic overview of warfarin and its drug and food interactions.

          Anne M Holbrook, Jennifer Pereira, Renée Labiris … (2005)
          Warfarin is a highly efficacious oral anticoagulant, but its use is limited by a well-founded fear of bleeding. Drug and food interactions are frequently cited as causes of adverse events with warfarin. We provide an updated systematic overview of the quality, clinical effect, and importance of these reported interactions. MEDLINE, TOXLINE, IPA, and EMBASE databases from October 1993 to March 2004. Database searches combined the keyword warfarin with drug interactions, herbal medicines, Chinese herbal drugs, and food-drug interactions. Eligible articles contained original reports of warfarin drug or food interactions in human subjects. Non-English articles were included if sufficient information could be abstracted. Reports were rated independently by 2 investigators for interaction direction, clinical severity, and quality of evidence. Quality of evidence was based on previously validated causation criteria and study design. Of 642 citations retrieved, 181 eligible articles contained original reports on 120 drugs or foods. Inter-rater agreement was excellent, with weighted kappa values of 0.84 to 1.00. Of all reports, 72% described a potentiation of warfarin's effect and 84% were of poor quality, 86% of which were single case reports. The 31 incidents of clinically significant bleeding were all single case reports. Newly reported interactions included celecoxib, rofecoxib, and herbal substances, such as green tea and danshen. The number of drugs reported to interact with warfarin continues to expand. While most reports are of poor quality and present potentially misleading conclusions, the consistency of reports of interactions with azole antibiotics, macrolides, quinolones, nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors, selective serotonin reuptake inhibitors, omeprazole, lipid-lowering agents, amiodarone, and fluorouracil, suggests that coadministration with warfarin should be avoided or closely monitored. More systematic study of warfarin drug interactions in patients is urgently needed.
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            A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa.

            M. Karbarz, K Abe, G. Q. (Max) Lu … (2013)
            Inhibitors of coagulation factor Xa (fXa) have emerged as a new class of antithrombotics but lack effective antidotes for patients experiencing serious bleeding. We designed and expressed a modified form of fXa as an antidote for fXa inhibitors. This recombinant protein (r-Antidote, PRT064445) is catalytically inactive and lacks the membrane-binding γ-carboxyglutamic acid domain of native fXa but retains the ability of native fXa to bind direct fXa inhibitors as well as low molecular weight heparin-activated antithrombin III (ATIII). r-Antidote dose-dependently reversed the inhibition of fXa by direct fXa inhibitors and corrected the prolongation of ex vivo clotting times by such inhibitors. In rabbits treated with the direct fXa inhibitor rivaroxaban, r-Antidote restored hemostasis in a liver laceration model. The effect of r-Antidote was mediated by reducing plasma anti-fXa activity and the non-protein bound fraction of the fXa inhibitor in plasma. In rats, r-Antidote administration dose-dependently and completely corrected increases in blood loss resulting from ATIII-dependent anticoagulation by enoxaparin or fondaparinux. r-Antidote has the potential to be used as a universal antidote for a broad range of fXa inhibitors.
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              Use of PER977 to reverse the anticoagulant effect of edoxaban.

              Jack E Ansell, Sasha H Bakhru, Bryan Laulicht … (2014)
              Article 0 comments Cited 98 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Jamshed Dalal
                Journal
                Journal ID (nlm-ta): Indian Heart J
                Journal ID (iso-abbrev): Indian Heart J
                Title: Indian Heart Journal
                Publisher: Elsevier
                ISSN (Print): 0019-4832
                Publication date (Print): Jul-Aug 2016
                Publication date (Electronic): 11 January 2016
                Volume: 68
                Issue: 4
                Pages: 559-563
                Affiliations
                [a ]Director, Centre for Cardiac Sciences, Kokilaben Dhirubhai Ambani Hospital, Rao Saheb Achutrao Patwardhan Marg, Four Bunglows, Andheri (W), Mumbai 400053, India
                [b ]Hon. Consultant Haematologist, Lilavati Hospital and Research Centre, Mumbai, India
                [c ]Senior Manager Medical Affairs, Boehringer Ingelheim India Pvt. Ltd, India
                [d ]Manager Medical Services, Boehringer Ingelheim India Pvt. Ltd, India
                Author notes
                [* ] Corresponding author. jjdalal@ 123456hotmail.com
                Article
                Publisher ID: S0019-4832(15)00881-0
                DOI: 10.1016/j.ihj.2015.11.023
                PMC ID: 4990727
                PubMed ID: 27543482
                SO-VID: e4970dc3-34a4-4ce4-85f1-b251c13b745a
                Copyright © © 2015 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.
                License:

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                Date received : 3 November 2015
                Date accepted : 16 November 2015
                Categories
                Subject: Review Article

                Keywords: noac, non vitamin k oral anticoagulant,vka, vitamin k antagonist,ich, intracranial hemorrhage,pcc, prothrombin complex concentrate,spaf,noacs,reversal agents,idarucizumab,adexanet alfa
                Data availability:
                Keywords: noac, non vitamin k oral anticoagulant, vka, vitamin k antagonist, ich, intracranial hemorrhage, pcc, prothrombin complex concentrate, spaf, noacs, reversal agents, idarucizumab, adexanet alfa

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