Balancing the benefits and risks of 2 doses of dabigatran compared with warfarin in atrial fibrillation

Journal of the American College of Cardiology

Volumn 62, Issue 10, 2013, Pages 900-908

  Eikelboom, John W ^a   Connolly, Stuart J ^a   Hart, Robert G ^a   Wallentin, Lars ^b   Reilly, Paul ^c   Oldgren, Jonas ^b   Yang, Sean ^a   Yusuf, Salim ^a  

^a MCMASTER UNIVERSITY   (Canada)

^b UPPSALA UNIVERSITY   (Sweden)

^c BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

atrial fibrillation; dabigatran; net benefit; warfarin

Indexed keywords

DABIGATRAN; WARFARIN;

AGED; ARTICLE; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE COMPARISON; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; EMBOLISM; FEMALE; HEART ATRIUM FIBRILLATION; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MORTALITY; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; RISK REDUCTION; SENSITIVITY ANALYSIS; SUBDURAL HEMATOMA; TREATMENT OUTCOME;

AF; ATRIAL FIBRILLATION; CENTRAL NERVOUS SYSTEM; CI; CNS; CONFIDENCE INTERVAL; DABIGATRAN; FDA; FOOD AND DRUG ADMINISTRATION; MI; MYOCARDIAL INFARCTION; NET BENEFIT; TIA; TRANSIENT ISCHEMIC ATTACK; WARFARIN;

AGED; ANTICOAGULANTS; ANTITHROMBINS; ATRIAL FIBRILLATION; BENZIMIDAZOLES; BETA-ALANINE; FEMALE; HEMORRHAGE; HUMANS; MALE; RISK FACTORS; STROKE; TREATMENT OUTCOME; WARFARIN;

EID: 84883259388     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2013.05.042     Document Type: Article

References (18)

1. S.J. Connolly, M.D. Ezekowitz, and S. Yusuf Dabigatran versus warfarin in patients with atrial fibrillation N Engl J Med 361 2009 1139 1151
2. S.J. Connolly, M.D. Ezekowitz, S. Yusuf, P.A. Reilly, and L. Wallentin Newly identified events in the RE-LY trial N Engl J Med 363 2010 1875 1876
3. J.W. Eikelboom, L. Wallentin, and S.J. Connolly 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 123 2011 2363 2372
4. B.N. Beasley, E.F. Unger, and R. Temple Anticoagulant options-why the FDA approved a higher but not a lower dose of dabigatran N Engl J Med 364 2011 1788 1790
5. S.J. Connolly, J.W. Eikelboom, and J. Ng Net clinical benefit of adding clopidogrel to aspirin therapy in patients with atrial fibrillation for whom vitamin K antagonists are unsuitable Ann Intern Med 155 2011 579 586
6. M.D. Ezekowitz, S. Connolly, and A. Parekh Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran Am Heart J 157 2009 805 810 810
7. S. Connolly, J. Pogue, and R. Hart Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial Lancet 367 2006 1903 1912
8. S.J. Connolly, J. Pogue, and R.G. Hart Effect of clopidogrel added to aspirin in patients with atrial fibrillation N Engl J Med 360 2009 2066 2078
9. A.J. Camm, P. Kirchhof, and G.Y. Lip Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Eur Heart J 31 2010 2369 2429
10. D.W. Cockcroft, and M.H. Gault Prediction of creatinine clearance from serum creatinine Nephron 16 1976 31 41
11. K.S. Hong, L.K. Ali, S.L. Selco, G.C. Fonarow, and J.L. Saver Weighting components of composite end points in clinical trials: an approach using disability-adjusted life-years Stroke 42 2011 1722 1729
12. D.E. Singer, Y. Chang, and M.C. Fang The net clinical benefit of warfarin anticoagulation in atrial fibrillation Ann Intern Med 151 2009 297 305
13. J.B. Olesen, G.Y. Lip, and J. Lindhardsen Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study Thromb Haemost 106 2011 739 749
14. A. Banerjee, D.A. Lane, C. Torp-Pedersen, and G.Y. Lip Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study Thromb Haemost 107 2012 584 589
15. S.V. Rao, K. O'Grady, and K.S. Pieper Impact of bleeding severity on clinical outcomes among patients with acute coronary syndromes Am J Cardiol 96 2005 1200 1206
16. P.G. Steg, K. Huber, and F. Andreotti Bleeding in acute coronary syndromes and percutaneous coronary interventions: position paper by the Working Group on Thrombosis of the European Society of Cardiology Eur Heart J 32 2011 1854 1864
17. J.W. Eikelboom, S.R. Mehta, S.S. Anand, C. Xie, K.A. Fox, and S. Yusuf Adverse impact of bleeding on prognosis in patients with acute coronary syndromes Circulation 114 2006 774 782
18. P.J. Devereaux, D.R. Anderson, and M.J. Gardner Differences between perspectives of physicians and patients on anticoagulation in patients with atrial fibrillation: observational study BMJ 323 2001 1218 1222