A randomized trial of the safety, Pharmacokinetics and pharmacodynamics of edoxaban, An oral factor Xa inhibitor, Following a switch from warfarin

British Journal of Clinical Pharmacology

Volumn 75, Issue 4, 2013, Pages 966-978

  Mendell, Jeanne ^a   Noveck, Robert J ^b   Shi, Minggao ^a  

^a DAIICHI SANKYO INC   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Atrial fibrillation; Edoxaban; Pharmacodynamics; Pharmacokinetics; Safety; Warfarin

Indexed keywords

BLOOD CLOTTING FACTOR 10A; EDOXABAN; PLACEBO; PROTHROMBIN; THROMBIN; WARFARIN;

ADULT; ARTICLE; BLOOD CLOTTING; CONTROLLED STUDY; COUGHING; DIZZINESS; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EYE DISEASE; FEMALE; GINGIVA BLEEDING; HUMAN; HUMAN EXPERIMENT; INTERNATIONAL NORMALIZED RATIO; MALE; NORMAL HUMAN; OCCULT BLOOD; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SORE THROAT; TREATMENT DURATION;

EID: 84870319847     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2012.04409.x     Document Type: Article

References (20)

1. Singer DE, Albers GW, Dalen JE, Fang MC, Go AS, Halperin JL, Lip GY, Manning WJ. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: (Suppl 6): 546S-592.
2. Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL, American College of Cardiology, American Heart Association Task Force, European Society of Cardiology Committee for Practice Guidelines, European Heart Rhythm Association, Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 guidelines for the management of patients with atrial fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace 2006; 8: 651-745.
3. Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ, American College of Chest Physicians. Antithrombotic therapy for venous thromboembolic disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: (Suppl 6): 454S-545S.
4. Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G, American College of Chest Physicians. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: (Suppl 6): 160S-198.
5. Turpie AG. New oral anticoagulants in atrial fibrillation. Eur Heart J 2008; 29: 155-165.
6. Weitz JI, Connolly SJ, Patel I, Salazar D, Rohatagi S, Mendell J, Kastrissios H, Jin J, Kunitada S. Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost 2010; 104: 633-641.
7. Matsushima N, Lee F, Sato T, Weiss D, Mendell J. Absolute bioavailability of edoxaban in healthy subjects. Poster presented at: American Association of Pharmaceutical Scientists Annual Meeting and Exposition 2011, October 23-27, Washington, DC.
8. Ogata K, Mendell-Harary J, Tachibana M, Masumoto H, Oguma T, Kojima M, Kunitada S. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol 2010; 50: 743-753.
9. Daiichi Sankyo Inc., 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 (ENGAGE AF TIMI-48). Available at http://www.clinicaltrials.gov/ct2/results?term=NCT00781391 (last accessed 3 August 2012).
10. 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 Blood Clots. (The Edoxaban Hokusai-VTE Study.) Available at http://www.clinicaltrials.gov/ct2/results?term=NCT00986154 (last accessed 3 August 2012).
11. Wolzt M, Samama MM, Kapiotis S, Ogata K, Mendell J, Kunitada S. Effect of edoxaban on markers of coagulation in venous and shed blood compared with fondaparinux. Thromb Haemost 2011; 105: 1080-1090.
12. van Walraven C, Jennings A, Oake N, Fergusson D, Forster AJ. Effect of study setting on anticoagulation control: a systematic review and metaregression. Chest 2006; 129: 1155-1166.
13. Calatzis A, Peetz D, Haas S, Spannagl M, Rudin K, Wilmer M. Prothrombinase-induced clotting time assay for determination of the anticoagulant effects of unfractionated and low-molecular-weight heparins, fondaparinux, and thrombin inhibitors. Am J Clin Pathol 2008; 130: 446-454.
14. Graff J, Picard-Willems B, Harder S. Monitoring effects of direct FXa-inhibitors with a new one-step prothrombinase-induced clotting time (PiCT) assay: comparative in vitro investigation with heparin, enoxaparin, fondaparinux and DX 9065a. Int J Clin Pharmacol Ther 2007; 45: 237-243.
15. Samama MM, Flem LL, Guinet C, Perzborn E, Depasse F. Measuring rivaroxaban pharmacodynamics: prothrombinase-induced clotting time (PiCT®) and Heptest®. Poster presented at: 20th International Congress on Thrombosis (ICT), June 25-28, 2008, Athens, Greece.
16. Chen H, Ding Q, Wang X, Wang H. Investigations of thrombin generation tests in warfarin taking patients. J Thromb Haemost 2007; 5: (Suppl 2): P-S-693.
17. Samama MM, Kunitada S, Oursin A, Depasse F, Heptinstall S. Comparison of a direct Factor Xa inhibitor, edoxaban, with dalteparin and ximelagatran: a randomised controlled trial in healthy elderly adults. Thromb Res 2010; 126: e286-293.
18. Haas S. Facts and artefacts of coagulation assays for factor Xa inhibitors. Thromb Haemost 2010; 103: 686-688.
19. Gross PL, Weitz JI. New anticoagulants for treatment of venous thromboembolism. Arterioscler Thromb Vasc Biol 2008; 28: 380-386.
20. Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J 2010; 160: 635-641.