Literature DB >> 26889284

Idarucizumab: A novel antidote for reversal of dabigatran.

Abdul Rehman1, Muhammad Awais1, Noor Ul-Ain Baloch1.   

Abstract

Entities:  

Year:  2016        PMID: 26889284      PMCID: PMC4732247          DOI: 10.4103/1793-5482.165795

Source DB:  PubMed          Journal:  Asian J Neurosurg


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Sir, We read with great interest a recent article by Dwyer et al. about dabigatran that was published in, April 2015 issue of the Asian Journal of Neurosurgery.[1] In this article, authors are provided a brief, but comprehensive review of the clinical efficacy and safety of dabigatran. Dwyer et al. wrote that “there is no specific reversal agent for dabigatran” and proposed an algorithm of dabigatran reversal based on the replacement of deficient coagulation factors and rapid renal dialysis. However, in our opinion, this connotation is now obsolete – A novel drug has been reported to have excellent efficacy and safety for rapid reversal of dabigatran.[2345] Idarucizumab is a monoclonal antibody directed against dabigatran and binds to it 350 times more avidly than thrombin. In preliminary findings from the RE-VERSE AD trial (which were published in the New England Journal of Medicine on June 22, 2015), Pollack et al. demonstrated the safety and efficacy of idarucizumab for reversal of dabigatran in 90 patients.[2] In all these patients, anticoagulant effects of dabigatran were reversed with remarkable efficacy (88–90%) and safety. The RE-VERSE AD trial is still on-going and aims to recruit 300 patients in nearly 400 hospitals are located in 38 different countries of the world. In another Phase I trial published online in the Lancet on June 15, 2015, Glund et al. reported the safety and efficacy of idarucizumab in 47 healthy volunteers.[3] No serious adverse effects of idarucizumab were reported in any of these healthy subjects. In view of these reported findings, idarucizumab is a novel and promising drug for reversal of dabigatran. While, we do acknowledge that these trials were only recently reported and that idarucizumab is not widely available at the moment, it is still important for all the scientists in general and neurosurgeons in particular, to keep abreast with the latest developments in the field of medicine. It seems very likely that in the near future, idarucizumab would become the first-line antidote for reversal of dabigatran.

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Conflicts of interest

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  3 in total

1.  Idarucizumab for Dabigatran Reversal.

Authors:  Charles V Pollack; Paul A Reilly; John Eikelboom; Stephan Glund; Peter Verhamme; Richard A Bernstein; Robert Dubiel; Menno V Huisman; Elaine M Hylek; Pieter W Kamphuisen; Jörg Kreuzer; Jerrold H Levy; Frank W Sellke; Joachim Stangier; Thorsten Steiner; Bushi Wang; Chak-Wah Kam; Jeffrey I Weitz
Journal:  N Engl J Med       Date:  2015-06-22       Impact factor: 91.245

2.  Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial.

Authors:  Stephan Glund; Joachim Stangier; Michael Schmohl; Dietmar Gansser; Stephen Norris; Joanne van Ryn; Benjamin Lang; Steven Ramael; Viktoria Moschetti; Fredrik Gruenenfelder; Paul Reilly; Jörg Kreuzer
Journal:  Lancet       Date:  2015-06-15       Impact factor: 79.321

3.  What neurosurgeons need to know about dabigatran etexilate (pradax(®)/pradaxa(®)/prazaxa(®)).

Authors:  Christopher Michael Dwyer; Omprakash Damodaran; Michael Heckelmann; Mark Michael Sheridan
Journal:  Asian J Neurosurg       Date:  2015 Apr-Jun
  3 in total

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