Efficacy and safety of novel anticoagulant dabigatran in clinical practice for Japanese patients with non-valvular atrial fibrillation

Journal of Arrhythmia

Volumn 30, Issue 1, 2014, Pages 58-64

  Miyamoto, Koji ^a,b   Aiba, Takeshi ^a   Nakajima, Ikutaro ^a   Yamada, Yuko ^a   Okamura, Hideo ^a,b   Noda, Takashi ^a   Satomi, Kazuhiro ^a   Ishihara, Masaharu ^a,b   Anzai, Toshihisa ^a,b   Yasuda, Satoshi ^a,b   Ogawa, Hisao ^a,b   Kamakura, Shiro ^a   Shimizu, Wataru ^a,b,c  

^a NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^b KUMAMOTO UNIVERSITY   (Japan)

^c NIPPON MEDICAL SCHOOL   (Japan)

Author keywords

Atrial fibrillation; Dabigatran; Efficacy; Japanese; Safety

Indexed keywords

EID: 84897649456     PISSN: 18804276     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.joa.2013.04.010     Document Type: Article

References (28)

1. Barnes GD, Froehlich JB Anticoagulation: where we are and where we need to go. J Thromb Thrombolysis 2009; 28:220-3.
2. Schulman S, Kearon C, Kakkar A.K., et al Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009; 361:2342-52.
3. Singer DE, Chang Y, Fang M.C., et al The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann Intern Med 2009; 15:297-305.
4. Connolly SJ, Ezekowitz MD, Yusuf S, et al Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361:1139-51.
5. 2 score: a subgroup analysis of the RE-LY trial. Ann Intern Med 2011; 155:660-7.
6. Healey JS, Eikelboom J, Douketis J., et al Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation 2012; 126:343-8.
7. Nagarakanti R, Ezekowitz MD, Oldgren J, et al Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation 2011; 123:131-6.
8. Wann LS, Curtis AB, Ellenbogen K.A., et al ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on Dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2011 2011; 123:1144-50.
9. Camm AJ, Lip GY, De Caterina R, et al focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 2012 2012; 33:2719-47.
10. Hori M, Connolly SJ, Ezekowitz M.D., et al Efficacy and safety of dabigatran vs. warfarin in patients with atrial fibrillation-sub-analysis in Japanese population in RE-LY trial. Circ J 2011; 75:800-5.
11. Suzuki S, Otsuka T, Sagara K., et al Dabigatran in clinical practice for atrial fibrillation with special reference to activated partial thromboplastin time. Circ J 2012; 76:755-7.
12. Kaseno K, Naito S, Nakamura K., et al Efficacy and safety of periprocedural dabigatran in patients undergoing catheter ablation of atrial fibrillation. Circ J 2012; 76:2337-42.
13. Uchiyama S, Ibayashi S, Matsumoto M., et al Dabigatran and factor Xa inhibitors for stroke prevention in patients with nonvalvular atrial fibrillation. J Stroke Cerebrovasc Dis 2012; 21:165-73.
14. Cockcroft DW, Gault MH Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16:31-41.
15. Gage BF, Waterman AD, Shannon W, et al Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001; 285:2864-70.
16. Lip GY, Nieuwlaat R, Pisters R., et al Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010; 137:263-72.
17. Lip GY, Frison L, Halperin J.L., et al Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J Am Coll Cardiol 2011; 57:173-80.
18. Ogawa S, Hori M. Urgent statement on antithrombotic therapy of atrial fibrillation. Circ J 2011; 75:2719-21.
19. Lauer A, Cianchetti FA, Van Cott EM, et al Anticoagulation with the oral direct thrombin inhibitor dabigatran does not enlarge hematoma volume in experimental intracerebral hemorrhage. Circulation 2011; 124:1654-62.
20. van Ryn J., Stangier J, Haertter S., et al Dabigatran etexilate-a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemostasis 2010; 103:1116-27.
21. Liesenfeld KH, Lehr T, Dansirikul C., et al Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with non-valvular atrial fibrillation from the RE-LY trial. J Thromb Haemostasis 2011; 9:2168-75.
22. Stangier J, Stahle H, Rathgen K., et al Pharmacokinetics and pharmacody-namics of the direct oral thrombin inhibitor dabigatran in healthy elderly subjects. Clin Pharmacokinet 2008; 47:47-59.
23. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet 2008; 47:285-95.
24. Gaede P, Vedel P, Larsen N., et al Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med 2003; 348:383-93.
25. Walker WG, Neaton JD, Cutler J.A., et al Renal function change in hypertensive members of the Multiple Risk Factor Intervention Trial. Racial and treatment effects. MRFIT Res Group. JAMA 1992; 268:3085-91.
26. Eikelboom JW, Wallentin L, Connolly S.J., et al Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation 2011; 123:2363-72.
27. Jaszewski R. Frequency of gastroduodenal lesions in asymptomatic patients on chronic aspirin or nonsteroidal antiinflammatory drug therapy. J Clin Gastro-enterol 1990; 12:10-3.
28. Lakkireddy D, Reddy YM, Di Biase L, et al Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry. J Am Coll Cardiol 2012; 59:1168-74.