Comparison of a direct Factor Xa inhibitor, edoxaban, with dalteparin and ximelagatran: A randomised controlled trial in healthy elderly adults

Thrombosis Research

Volumn 126, Issue 4, 2010, Pages

  Samama, Meyer M ^a   Kunitada, Satoshi ^b   Oursin, Andŗe ^a   Depasse, Francois ^a   Heptinstall, Stan ^c  

^a Biomnis   (France)

^b DAIICHI SANKYO INC   (United States)

^c UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

Anticoagulants; Blood coagulation; Edoxaban, ximelagatran, dalteparin

Indexed keywords

BLOOD CLOTTING FACTOR 10A INHIBITOR; D DIMER; DALTEPARIN; EDOXABAN; FRAGMIN P FORTE; PROTHROMBIN; THROMBIN ANTITHROMBIN COMPLEX; UNCLASSIFIED DRUG; XIMELAGATRAN;

AGED; ARTICLE; BLOOD CLOTTING; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; ENDOTHELIUM CELL; FATIGUE; FEMALE; FLATULENCE; HEADACHE; HOT FLUSH; HUMAN; HUMAN EXPERIMENT; LIMB PAIN; MALE; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; THROMBOCYTE ACTIVATION; XEROSTOMIA;

ADMINISTRATION, CUTANEOUS; ADMINISTRATION, ORAL; AGED; ANTICOAGULANTS; ANTITHROMBINS; AZETIDINES; BENZYLAMINES; BLOOD COAGULATION; DALTEPARIN; FACTOR XA; FEMALE; HUMANS; MALE; PYRIDINES; THIAZOLES; THROMBOSIS;

EID: 77957137721     PISSN: 00493848     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.thromres.2010.07.015     Document Type: Article

References (37)

1. C. Kearon, S.R. Kahn, G. Agnelli, S. Goldhaber, G.E. Raskob, and A.J. Comerota Antithrombotic therapy for venous thromboembolic disease: American college of chest physicians evidence-based clinical practice guidelines (8th edition) Chest 133 2008 454S 545S
2. D.E. Singer, G.W. Albers, J.E. Dalen, M.C. Fang, A.S. Go, and J.L. Halperin Antithrombotic therapy in atrial fibrillation: American college of chest physicians evidence-based clinical practice guidelines (8th edition) Chest 133 2008 546S 592S
3. J. Ansell, J. Hirsh, E. Hylek, A. Jacobson, M. Crowther, and G. Palareti Pharmacology and management of the vitamin k antagonists: American college of chest physicians evidence-based clinical practice guidelines (8th edition) Chest 133 2008 160S 198S
4. J. Hirsh, K.A. Bauer, M.B. Donati, M. Gould, M.M. Samama, and J.I. Weitz Parenteral anticoagulants: American college of chest physicians evidence-based clinical practice guidelines (8th edition) Chest 133 2008 141S 159S
5. J. Hirsh, G. Guyatt, G.W. Albers, R. Harrington, and H.J. Schunemann American College of Chest P. Antithrombotic and thrombolytic therapy: American college of chest physicians evidence-based clinical practice guidelines (8th edition) Chest 133 2008 110S 112S
6. S. Schulman, R.J. Beyth, C. Kearon, and M.N. Levine Hemorrhagic complications of anticoagulant and thrombolytic treatment: American college of chest physicians evidence-based clinical practice guidelines (8th edition) Chest 133 2008 257S 298S
7. B.I. Eriksson, D.J. Quinlan, and J.I. Weitz Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor xa inhibitors in development Clin Pharmacokinet 48 2009 1 22
8. J.I. Weitz, J. Hirsh, and M.M. Samama New antithrombotic drugs: American college of chest physicians evidence-based clinical practice guidelines (8th edition) Chest 133 2008 234S 256S
9. J. Ansell Factor Xa or thrombin: is factor Xa a better target. J. Thromb. Haemost 5 suppl1 2007 60 64
10. J.I. Weitz Factor xa or thrombin: Is thrombin a better target? J Thromb Haemost 5 Suppl 1 2007 65 67
11. A. Choudhury, D. Goyal, and G.Y. Lip Ximelagatran Drugs Today (Barc) 42 2006 3 19
12. D.K. Cundiff Clinical evidence for rebound hypercoagulability after discontinuing oral anticoagulants for venous thromboembolism Medscape J Med 10 2008 258
13. E.W. Davie, and J.D. Kulman An overview of the structure and function of thrombin Semin Thromb Hemost 32 Suppl 1 2006 3 15
14. C.T. Esmon The protein C pathway Chest 124 2003 26S 32S
15. T. Furugohri, K. Isobe, Y. Honda, C. Kamisato-Matsumoto, N. Sugiyama, and T. Nagahara Du-176b, a potent and orally active factor Xa inhibitor: In vitro and in vivo pharmacological profiles J Thromb Haemost 6 2008 1542 1549
16. K. Ogata, J. Mendell-Harary, M. Tachibana, H. Matsumoto, T. Oguma, and M. Kojima Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers J Clin Pharmacol January 15 2010 [Epub ahead of print]
17. M.U. Zafar, D.A. Vorchheimer, J. Gaztanaga, M. Velez, D. Yadegar, and P.R. Moreno Antithrombotic effects of factor xa inhibition with du-176b: Phase-i study of an oral, direct factor Xa inhibitor using an ex-vivo flow chamber Thromb Haemost 98 2007 883 888
18. D. Bergqvist, J.H. Solhaug, L. Holmdahl, U.G. Eriksson, M. Andersson, and B. Boberg Pharmacokinetics, preliminary efficacy and safety of subcutaneous melagatran and oral ximelagatran : A multicentre study of thromboprophylaxis in elective abdominal surgery Clin Drug Investig 24 2004 127 136
19. T.C. Sarich, U.G. Eriksson, C. Mattsson, M. Wolzt, L. Frison, and G. Fager Inhibition of thrombin generation by the oral direct thrombin inhibitor ximelagatran in shed blood from healthy male subjects Thromb Haemost 87 2002 300 305
20. G.T. Gerotziafas, A.D. Petropoulou, E. Verdy, M.M. Samama, and I. Elalamy Effect of the anti-factor Xa and anti-factor IIa activities of low-molecular-weight heparins upon the phases of thrombin generation J Thromb Haemost 5 2007 955 962
21. E. Perzborn, D. Kubitza, and F. Misselwitz Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders Hamostaseologie 27 2007 282 289
22. K.R. Guertin, and Y.M. Choi The discovery of the Factor Xa inhibitor Otamixaban: from lead identification to clinical development Curr Med Chem 14 2007 2471 2481
23. A. Paccaly, A. Frick, M.L. Ozoux, V. Chu, R. Rosenburg, and M. Hinder Pharmacokinetic/pharmacodynamic relationships for otamixaban, a direct factor xa inhibitor, in healthy subjects J Clin Pharmacol 46 2006 45 51
24. D. Kubitza, M. Becka, A. Roth, and W. Mueck Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects Curr Med Res Opin 24 2008 2757 2765
25. D. Kubitza, M. Becka, G. Wensing, B. Voith, and M. Zuehlsdorf Safety, pharmacodynamics, and pharmacokinetics of bay 59-7939-an oral, direct factor xa inhibitor-after multiple dosing in healthy male subjects Eur J Clin Pharmacol 61 2005 873 880
26. J. Graff, N. von Hentig, F. Misselwitz, D. Kubitza, M. Becka, and H.K. Breddin Effects of the oral, direct factor xa inhibitor rivaroxaban on platelet-induced thrombin generation and prothrombinase activity J Clin Pharmacol 47 2007 1398 1407
27. W.D. Fisher, B.I. Eriksson, K.A. Bauer, L. Borris, O.E. Dahl, and M. Gent Rivaroxaban for thromboprophylaxis after orthopaedic surgery: Pooled analysis of two studies Thromb Haemost 97 2007 931 937
28. M.R. Lassen, B.L. Davidson, A. Gallus, G. Pineo, J. Ansell, and D. Deitchman The efficacy and safety of apixaban, an oral, direct factor xa inhibitor, as thromboprophylaxis in patients following total knee replacement J Thromb Haemost 5 2007 2368 2375
29. A.G. Turpie, K.A. Bauer, B.I. Eriksson, and M.R. Lassen Fondaparinux vs enoxaparin for the prevention of venous thromboembolism in major orthopedic surgery: A meta-analysis of 4 randomized double-blind studies Arch Intern Med 162 2002 1833 1840
30. B.I. Eriksson, D. Bergqvist, P. Kalebo, O.E. Dahl, S. Lindbratt, and A. Bylock Ximelagatran and melagatran compared with dalteparin for prevention of venous thromboembolism after total hip or knee replacement: The methro ii randomised trial Lancet 360 2002 1441 1447
31. B.I. Eriksson, O.E. Dahl, N. Rosencher, A.A. Kurth, C.N. van Dijk, and S.P. Frostick Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: A randomised, double-blind, non-inferiority trial Lancet 370 2007 949 956
32. S. Robert, J. Ghiotto, B. Pirotte, J.L. David, B. Masereel, and L. Pochet Is thrombin generation the new rapid, reliable and relevant pharmacological tool for the development of anticoagulant drugs? Pharmacol Res 2008 S1043 S1066
33. M.M. Samama, M. Woltz, K. Ogata, J. Mendell, and S. Kunitada Effect of edoxaban (DU-176b) on thrombin generation and platelet activation in shed and venous blood with fondaparinux as active comparator European Society of Cardiology Meeting August 31 2009 Barcelona, Spain, Abstract #85736.
34. Daiichi Sankyo Inc. and The TIMI Study Group. Global study to assess the safety and effectiveness of Du-176b vs standard practice of dosing with warfarin in patients with atrial fibrillation. http://www.clinicaltrials.gov NLM identifier: #NCT0078139. Updated January 20, 2010. Accessed March 1, 2010.
35. Daiichi Sankyo Inc. Comparative investigation of low molecular weight (lmw) heparin / edoxaban tosylate (DU176b) versus (lmw) heparin / warfarin in the treatment of symptomatic deep-vein blood clots and / or lung clots. http://www.clinicaltrials.gov NLM identifier: #NCT00986154. Updated February 17, 2010. Accessed March 1, 2010.
36. M. Wolzt, S.L. Bostrom, M. Svensson, K. Wahlander, M. Grind, and T.C. Sarich Effects of the oral direct thrombin inhibitor ximelagatran on p-selectin expression and thrombin generation in atrial fibrillation Pathophysiol Haemost Thromb 33 2003 68 74
37. Samama MM, Amiral J, Guinet C, Perzborn E, Depasse F. Specific and rapid measurement of rivaroxaban in plasma using a new, dedicated chromogenic assay. German Society of Thrombosis and Haemostasis Meeting; in press. Nuremburg, Germany.