The impact of a three-factor prothrombin complex concentrate on the anticoagulatory effects of the factor Xa inhibitor edoxaban

Thrombosis Research

Volumn 136, Issue 4, 2015, Pages 825-831

  Brown, Karen S ^a   Wickremasingha, Prachi ^b   Parasrampuria, Dolly A ^a   Weiss, Daniel ^c   Kochan, Jarema ^a   Dishy, Victor ^a   He, Ling ^a   Shi, Minggao ^a  

^a DAIICHI SANKYO INC   (United States)

^b Certified Consultant Pharmacists Inc   (United States)

^c CELGENE CORPORATION   (United States)

Author keywords

3F PCC; Coagulation; Edoxaban; Pharmacodynamics; Pharmacokinetics; Thrombin

Indexed keywords

D DIMER; EDOXABAN; PLACEBO; PROCOAGULANT; PROTHROMBIN COMPLEX; THREE FACTOR PROTHROMBIN COMPLEX CONCENTRATE; THROMBIN; UNCLASSIFIED DRUG; BLOOD CLOTTING FACTOR; BLOOD CLOTTING FACTOR 10A INHIBITOR; PROTHROMBIN COMPLEX CONCENTRATES; PYRIDINE DERIVATIVE; THIAZOLE DERIVATIVE;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ANTICOAGULATION; ARTICLE; CLINICAL ARTICLE; CONSTIPATION; CONTROLLED STUDY; CONTUSION; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SAFETY; DYSMENORRHEA; FEMALE; HEADACHE; HUMAN; LACERATION; MALE; METRORRHAGIA; MUSCULOSKELETAL DISEASE; NAUSEA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; RASH; SINGLE DRUG DOSE; VOMITING; BLOOD CLOTTING; COHORT ANALYSIS; DRUG EFFECTS; METABOLISM;

BLOOD COAGULATION; BLOOD COAGULATION FACTORS; COHORT STUDIES; FACTOR XA INHIBITORS; FEMALE; HUMANS; MALE; PYRIDINES; THIAZOLES;

EID: 84941879356     PISSN: 00493848     EISSN: 18792472     Source Type: Journal    
DOI: 10.1016/j.thromres.2015.07.012     Document Type: Article

References (36)

1. T. Furugohri, K. Isobe, Y. Honda, C. Kamisato-Matsumoto, N. Sugiyama, T. Nagahara, and et al. DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles J. Thromb. Haemost. 6 2008 1542 1549
2. ® edoxaban tosilate hydrate tablets [package insert] 2014 Daiichi Sankyo Co. Ltd. Tokyo, Japan
3. TM (edoxaban) tablets for oral use Full Prescribing Information 2015 Daiichi Sankyo Inc. Parsippany, NJ
4. ® (warfarin sodium). Package Insert 2011 Bristol-Myers Squibb Princeton, NJ
5. K. Ogata, J. Mendell-Harary, M. Tachibana, H. Masumoto, T. Oguma, M. Kojima, and et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers J. Clin. Pharmacol. 50 2010 743 753
6. M. Franchini, and G. Lippi Prothrombin complex concentrates: an update Blood Transfus. 8 2010 149 154
7. A. Kiraly, A. Lyden, U. Periyanayagam, J. Chan, and P.S. Pang Management of hemorrhage complicated by novel oral anticoagulants in the emergency department: case report from the northwestern emergency medicine residency Am. J. Ther. 20 2013 300 306
8. ® in the correction of coagulation abnormalities induced by dabigatran Int. J. Lab. Hematol. 35 2013 222 224
9. A. Srivastava, A.K. Brewer, E.P. Mauser-Bunschoten, N.S. Key, S. Kitchen, A. Llinas, and et al. Guidelines for the management of hemophilia Haemophilia 19 2013 e1 e47
10. A. Godier, A. Miclot, B. Le Bonniec, M. Durand, A.M. Fischer, J. Emmerich, and et al. Evaluation of prothrombin complex concentrate and recombinant activated factor VII to reverse rivaroxaban in a rabbit model Anesthesiology 116 2012 94 102
11. R. Marlu, E. Hodaj, A. Paris, P. Albaladejo, J.L. Cracowski, and G. Pernod Effect of non-specific reversal agents on anticoagulant activity of dabigatran and rivaroxaban: a randomised crossover ex vivo study in healthy volunteers Thromb. Haemost. 108 2012 217 224
12. M.K. Korber, E. Langer, S. Ziemer, E. Perzborn, C. Gericke, and C. von Heymann Measurement and reversal of prophylactic and therapeutic peak levels of rivaroxaban: an in vitro study Clin. Appl. Thromb. Hemost. 20 2013 735 740
13. E.S. Eerenberg, P.W. Kamphuisen, M.K. Sijpkens, J.C. Meijers, H.R. Buller, and M. Levi Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects Circulation 124 2011 1573 1579
14. M. Levi, K.T. Moore, C.F. Castillejos, D. Kubitza, S.D. Berkowitz, S.Z. Goldhaber, and et al. Comparison of three-factor and four-factor prothrombin complex concentrates regarding reversal of the anticoagulant effects of rivaroxaban in healthy volunteers J. Thromb. Haemost. 12 2014 1428 1436
15. H. Zahir, K.S. Brown, A. Vandell, M. Desai, J.F. Maa, V. Dishy, and et al. Edoxaban effects on bleeding following punch biopsy and reversal by a 4-factor prothrombin complex concentrate Circulation 131 2015 82 90
16. G. Escolar, V. Fernandez-Gallego, E. Arellano-Rodrigo, J. Roquer, J.C. Reverter, V.V. Sanz, and et al. Reversal of apixaban induced alterations in hemostasis by different coagulation factor concentrates: significance of studies in vitro with circulating human blood PLoS One 8 2013 e78696
17. A.B. Halim, M.M. Samama, and J. Mendell Ex vivo reversal of the anticoagulant effects of edoxaban Thromb. Res. 134 2014 909 913
18. Bebulin® (Factor IX IX Complex) Nanofiltered and Vapor Heated. Package Insert 2012 Baxter Healthcare Corporation Westlake Village, CA
19. J. Mendell, R. Basavapathruni, D. Swearingen, A. Draves, G. Zhang, and J. Morganroth A thorough electrocardiogram study of edoxaban, a novel factor Xa inhibitor J. Clin. Pharmacol. 51 2011 1241 1246
20. H. Ostermann, S. Haertel, S. Knaub, U. Kalina, K. Jung, and I. Pabinger Pharmacokinetics of Beriplex P/N prothrombin complex concentrate in healthy volunteers Thromb. Haemost. 98 2007 790 797
21. A.M. Galan, J.C. Reverter, J. Bozzo, M.R. Hernandez, G. Escolar, and J. Aznar-Salatti Assessment of potential thrombogenicity of coagulation factor IX concentrates in an in vitro model of human thrombogenesis Thromb. Res. 96 1999 383 389
22. A. Lubetsky, R. Hoffman, R. Zimlichman, A. Eldor, J. Zvi, V. Kostenko, and et al. Efficacy and safety of a prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulation Thromb. Res. 113 2004 371 378
23. A. Ruiz-Saez, A. Hong, A. Arguello, M. Echenagucia, A. Boadas, F. Fabbrizzi, and et al. Pharmacokinetics, thrombogenicity and safety of a double viral inactivated factor IX concentrate compared with a prothrombin complex concentrate Haemophilia 11 2005 583 588
24. E.M. Bershad, and J.I. Suarez Prothrombin complex concentrates for oral anticoagulant therapy-related intracranial hemorrhage: a review of the literature Neurocrit. Care. 12 2010 403 413
25. U. Kalina, H. Bickhard, and S. Schulte Biochemical comparison of seven commercially available prothrombin complex concentrates Int. J. Clin. Pract. 62 2008 1614 1622
26. T. Fukuda, Y. Honda, C. Kamisato, Y. Morishima, and T. Shibano Reversal of anticoagulant effects of edoxaban, an oral, direct factor Xa inhibitor, with haemostatic agents Thromb. Haemost. 107 2012 253 259
27. B. Laulicht, S. Bakhru, C. Lee, C. Baker, X. Jiang, E. Mathiowitz, and et al. Small molecule antidote for anticoagulants Circulation 126 2012 A11395
28. S. Bakhru, B. Laulicht, X. Jiang, L. Chen, M.A. Grosso, Y. Morishima, and et al. A synthetic small molecule antidote for anticoagulants Eur. Heart J. 34 2013 88 89 (Abstract 1078).
29. J.E. Ansell, S.H. Bakhru, B.E. Laulicht, S.S. Steiner, M. Grosso, K. Brown, and et al. Use of PER977 to reverse the anticoagulant effect of edoxaban N. Engl. J. Med. 371 2014 2141 2142
30. G. Lu, J. Kotha, J.M. Cardena, M.J. Herr, A. Pandey, J.T. Curnutte, and et al. In Vitro Characterization of Andexanet Alpha (PRT064445), a Specific fXa Inhibitor Antidote versus Aripazine (PER977), a Non-specific Reversal Agent Circulation 130 2014 A12218
31. M. Crowther, M. Kitt, M. McClure, U. Sinha, G. Lu, M. Karbar, and et al. Randomized, double-blind, placebo-controlled single ascending dose pharmacokinetic and pharmacodynamic study of PRT064445, a universal antidote for factor Xa inhibitors Arterioscler. Thromb. Vasc. Biol. 33 2013 (Abstract 10)
32. G. Lu, F.R. DeGuzman, S.J. Hollenbach, M.J. Karbarz, K. Abe, G. Lee, and et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa Nat. Med. 19 2013 446 451
33. ® (dabigatran etexilate mesylate) Receives FDA Breakthrough Therapy Designation [press release] Jun. 26 2014 Boehringer Ingelheim Ridgefield, CT (June 26, 2014. http://us.boehringer-ingelheim.com/news-events/press-releases/press-release-archive/2014/06-26-14-boehringer-ingelheim-investigational-antidote-pradaxa-dabigatran-etexilate-mesylate-fda-breakthrough-therapy-designation.html. Accesed October 6, 2014)
34. O. Grottke, J. van Ryn, H.M. Spronk, and R. Rossaint Prothrombin complex concentrates and a specific antidote to dabigatran are effective ex-vivo in reversing the effects of dabigatran in an anticoagulation/liver trauma experimental model Crit. Care 18 2014 R27
35. J. van Ryn, M. Schmoll, H. Pilu, L. Gheyle, J. Brys, P. Reilly, and et al. Effect of dabigatran on the ability to generate fibrin at a wound site and its reversal by idarucizumab, the antidote to dabigatran, in healthy volunteers: an exploratory marker of blood loss Circulation 130 2014 A18403
36. C.V. Pollack Jr, P.A. Reilly, J. Eikelboom, S. Glund, P. Verhamme, and R.A. Bernstein Idarucizumab for dabigatran reversal N. Engl. J. Med. 373 2015 511 520