Randomized, multicenter, warfarin-controlled phase II study of edoxaban in Japanese patients with non-valvular atrial fibrillation

Circulation Journal

Volumn 76, Issue 8, 2012, Pages 1840-1847

  Yamashita, Takeshi ^a   Koretsune, Yukihiro ^b   Yasaka, Masahiro ^c   Inoue, Hiroshi ^d   Kawai, Yohko ^e   Yamaguchi, Takenori ^f   Uchiyama, Shinichiro ^g   Matsumoto, Masayasu ^h   Ogawa, Satoshi ⁱ  

^a THE CARDIOVASCULAR INSTITUTE   (Japan)

^b OSAKA NATIONAL HOSPITAL   (Japan)

^c NATIONAL HOSPITAL ORGANIZATION KYUSHU MEDICAL CENTER   (Japan)

^d UNIVERSITY OF TOYAMA   (Japan)

^e INTERNATIONAL UNIVERSITY OF HEALTH AND WELFARE   (Japan)

^f NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^g TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^h HIROSHIMA UNIVERSITY   (Japan)

ⁱ International University of Health and Welfare Mita Hospital   (Japan)

Author keywords

Anticoagulants; Atrial fibrillation; Edoxaban; Warfarin

Indexed keywords

ACETYLSALICYLIC ACID; D DIMER; EDOXABAN; WARFARIN;

ADULT; AGED; ARTICLE; BLEEDING; BODY WEIGHT; BRAIN HEMORRHAGE; BRAIN INFARCTION; COMPUTER ASSISTED TOMOGRAPHY; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG SAFETY; DRUG WITHDRAWAL; EPISTAXIS; FEMALE; FOLLOW UP; HEART ATRIUM FIBRILLATION; HEMATURIA; HUMAN; INCIDENCE; INTERNATIONAL NORMALIZED RATIO; LIQUID CHROMATOGRAPHY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON VALVULAR HEART ATRIUM FIBRILLATION; NUCLEAR MAGNETIC RESONANCE IMAGING; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK; SIDE EFFECT; SUBCUTANEOUS HEMORRHAGE; TANDEM MASS SPECTROMETRY; THROMBOEMBOLISM;

AGED; ANTICOAGULANTS; ASIAN CONTINENTAL ANCESTRY GROUP; ATRIAL FIBRILLATION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HEMORRHAGE; HUMANS; INCIDENCE; INTERNATIONAL NORMALIZED RATIO; JAPAN; MALE; MIDDLE AGED; PYRIDINES; THIAZOLES; WARFARIN;

EID: 84864387139     PISSN: 13469843     EISSN: 13474820     Source Type: Journal    
DOI: 10.1253/circj.CJ-11-1140     Document Type: Article

References (25)

1. Hart RG, Pearce LA, Aguilar MI. Meta-analysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146: 857-867.
2. Singer DE, Albers GW, Dalen JE, Fang MC, Go AS, Halperin JL, et al. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008; 133: 546S-592S.
3. Ogawa S, For the Japanese Circulation Society Joint Working Groups. Guidelines for pharmacotherapy of atrial fibrillation. Circ J 2008; 72(Suppl IV): 1639-1658.
4. Choudhry NK, Soumerai SB, Normand SL, Ross-Degnan D, Laupacis A, Anderson GM. Warfarin prescribing in atrial fibrillation: The impact of physician, patient, and hospital characteristics. Am J Med 2006; 119: 607-615.
5. Go AS, Hylek EM, Borowsky LH, Phillips KA, Selby JV, Singer DE. Warfarin use among ambulatory patients with nonvalvular atrial fibrillation: The anticoagulation and risk factors in atrial fibrillation (ATRIA) study. Ann Intern Med 1999; 131: 927-934.
6. Ansell J, Hirsh J, Hylek E, Jacobson A, Crowther M, Palareti G. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest 2008; 133: 160S-198S.
7. Furugohri T, Isobe K, Honda Y, Kamisato-Matsumoto C, Sugiyama N, Nagahara T, et al. DU-176b, a potent and orally active factor Xa inhibitor: In vitro and in vivo pharmacological profiles. J Thromb Haemost 2008; 6: 1542-1549.
8. Matsushima N, Lee F, Sato T, Weiss D, Mendell J. Absolute bioavailability of edoxaban in healthy subjects. AAPS J 2011; 13(Suppl2). http://www.aapsj.org/abstracts/AM_2011/T2362.pdf (accessed April 19, 2012).
9. Ogata K, Mendell-Harary J, Tachibana M, Masumoto H, Oguma T, Kojima M, et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharmacol 2010; 50: 743-753.
10. Koretsune Y, Inoue H, Kawai Y, Uchiyama S, Yamaguchi T. The oral factor Xa inhibitor DU-176b in Japanese warfarin-naive patients with atrial fibrillation: Results of two phase II open-label, dose-escalation studies. Abstract presented at the 58th Annual Scientific Sessions of the American College of Cardiology; 29-31 March 2009; Orlando, FL, USA.
11. Weitz JI, Connolly SJ, Patel I, Salazar D, Rohatagi S, Mendell J, et al. 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.
12. Shinohara Y, Yamaguchi T. Outline of the Japanese guidelines for the management of stroke 2004 and subsequent revision. Int J Stroke 2008; 3: 55-62.
13. Yasaka M, Minematsu K, Yamaguchi T. Optimal intensity of international normalized ratio in warfarin therapy for secondary prevention of stroke in patients with non-valvular atrial fibrillation. Intern Med 2001; 40: 1183-1188.
14. Petersen P, Grind M, Adler J. Ximelagatran versus warfarin for stroke prevention in patients with nonvalvular atrial fibrillation: SPORTIF II: A dose-guiding, tolerability, and safety study. J Am Coll Cardiol 2003; 41: 1445-1451.
15. Rosendaal FR, Cannegieter SC, van der Meer FJ, Briët E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993; 69: 236-239.
16. Lovelock CE, Cordonnier C, Naka H, Al-Shahi Salman R, Sudlow CL; Edinburgh Stroke Study Group, et al. Antithrombotic drug use, cerebral microbleeds, and intracerebral hemorrhage: A systematic review of published and unpublished studies. Stroke 2010; 41: 1222-1228.
17. Lee SH, Ryu WS, Roh JK. Cerebral microbleeds are a risk factor for warfarin-related intracerebral hemorrhage. Neurology 2010; 72: 171-176.
18. Suzuki S, Yamashita T, Kato T, Fujino T, Sagara K, Sawada H, et al. Incidence of major bleeding complication of warfarin therapy in Japanese patients with atrial fibrillation. Circ J 2007; 71: 761-765.
19. Mak KH, Bhatt DL, Shao M, Hankey GJ, Easton JD, Fox KA, et al. Ethnic variation in adverse cardiovascular outcomes and bleeding complications in the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) study. Am Heart J 2009; 157: 658-665.
20. Wang TY, Chen AY, Roe MT, Alexander KP, Newby K, Smith SC, et al. Comparison of baseline characteristics, treatment patterns, and in-hospital outcomes of Asia versus non-Asian white Americans with non-ST-segment elevation acute coronary syndromes from the CRUSADE quality improvement initiative. Am J Cardiol 2007; 100: 391-396.
21. Shen AYJ, Yao JF, Brar SS, Jorgensen MB, Chen W. Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol 2007; 50: 309-315.
22. Atarashi H, Inoue H, Okumura K, Yamashita T, Kumagai N, Origasa H; J-RHYTHM Registry Investigators. Present status of anticoagulation treatment in Japanese patients with atrial fibrillation: A report from the J-RHYTHM Registry. Circ J 2011; 75: 1328-1333.
23. Vivas D, Olmos C, Vilacosta I. Atrial fibrillation and anticoagulation therapy: Different race, different risk, and different management? Circ J 2011; 75: 1314-1315.
24. Lip GY, Rasmussen LH, Olsson SB, Zetterstrand S, Stahre C, Bylock A, et al. Oral direct thrombin inhibitor AZD0837 for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: A Phase II study of AZD0837 in patients who are appropriate for but unable or unwilling to take vitamin K antagonist therapy. Thromb Res 2011; 127: 91-99.
25. Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, et al. 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.