DABIGATRAN ETEXILATE FOR PREVENTION OF CARDIOEMBOLIC COMPLICATIONS IN NONVALVULAR ATRIAL FIBRILLATION: HOW TO DO THE INTERVENTION MORE EFFECTIVE AND SAFER
https://doi.org/10.20996/1819-6446-2011-7-6-757-764
Abstract
Application of dabigatran etexilate for prevention of cardioembolic complications in nonvalvular atrial fibrillation is considered. Results of randomized clinical trials on efficacy and safety of dabigatran in various doses are discussed. Besides, a comparison of dabigatran and varfarin therapies is presented taking into account pharmacoeconomic data. Recommendations on dabigatran dosing are considered to do intervention more effective and safer.
About the Author
I. S. Yavelov
The Russian National Research Medical University named after N.I. Pirogov
Russian Federation
Russian Federation
References
1. 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 2010; 31: 2369-2429.
2. Fuster V., Ryden L., Cannom D. et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: 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. Circulation 2006; 114: e257–e354.
3. Hart R.G., Benavente O., McBride R., Pearce L.A. Antithrombotic Therapy To Prevent Stroke in Patients with Atrial Fibrillation: A Meta-Analysis. Ann Intern Med 1999; 131: 492-501.
4. Hart R.G., Pearce L.A., Aguilar M.I. Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Ann Intern Med 2007;146: 857-867.
5. Connolly S.J., Eikelboom J., Joyner C., for the AVERROES Steering Committee and Investigators. Apixaban in Patients with Atrial Fibrillation. N Engl J Med 2011; 364(9): 806-17.
6. The ACTIVE Investigators. Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation. N Engl J Med 2009; 360: 2066-2-78.
7. Ansell J., Hirsh J., Hylek E., et al. 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.
8. White H.D., Gruber M., Feyzi J., et al. Comparison of Outcomes Among Patients Randomized to War-farin Therapy According to Anticoagulant Control. Results From SPORTIF III and V. Arch Intern Med 2007; 167: 239-245.
9. Connolly S.J., Pogue J., Eikelboom J., et al.; on behalf of the ACTIVE W Investigators. Benefit of Oral Anticoagulant Over Antiplatelet Therapy in Atrial Fibrillation Depends on the Quality of International Normalized Ratio Control Achieved by Centers and Countries as Measured by Time in Therapeutic Range. Circulation 2008; 118: 2029-2037.
10. Lane D.A., Lip G.Y.H. Anticoagulation intensity for elderly atrial fibrillation patients: Should we use a conventional INR target (2.0 to 3.0) or a lower range? Thromb Haemost 2010; 103: 254-256.
11. Go A.S., Hylek E.M., Borowsky L.H., et al. 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.
12. Birman-Deych E., Radford M.J., Nilasena D.S., Gage B.F. Use and effectiveness of warfarin in Medicare beneficiaries with atrial fibrillation. Stroke 2006; 37:1070-1074.
13. Nieuwlaat R., Capucci A., Camm A.J., et al. Atrial fibrillation management: a prospective survey in ESC member countries: the Euro Heart Survey on Atrial Fibrillation. Eur Heart J 2005; 26: 2422-2434.
14. Connolly S.J., Ezekowitz M.D., Yusuf S., et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139–1151.
15. Patel M.R., Mahaffey K.W., Garg J., et al., and the ROCKET AF Steering Committee, for the ROCKET AF Investigators. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med 2011.
16. Granger C.B., Alexander J.H., McMurray J.J.V., et al., for the ARISTOTLE Committees and Investigators. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2011.
17. Ansell J., Hollowell J., Pengo V., et al. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the international study of anticoagulation management (ISAM). J Thromb Thrombolysis 2007; 23: 83-91.
18. Hylek E.M., Singer D.E. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 1994; 120: 897-902.
19. Connolly S.J., Ezekowitz M.D., Yusuf S., et al., for the Randomized Evaluation of Long-Term Anticoagulation Therapy Investigators. Newly Identified Events in the RE-LY Trial. N Engl J Med 2010; 363: 1875-1876.
20. Eikelboom J.W., Wallentin Lars, Connolly S., 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: 2363-2372.
21. Wallentin L., Yusuf S., Ezekowitz M.D., et al., on behalf of the RE-LY investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010; 376(9745): 975-83.
22. Shah S.V., Gage B.F. Cost-Effectiveness of Dabigatran for Stroke Prophylaxis in Atrial Fibrillation. Circulation 2011; 123: 2562-2570.
23. Freeman J.V., Zhu R.P., Owens D.K., et al. Cost-Effectiveness of Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation. Ann Intern Med 2011; 154: 1-11.
24. Cairns JA, Connolly S, McMurtry S, et al.; CCS Atrial Fibrillation Guidelines Committee. Canadian Cardiovascular Society atrial fibrillation guidelines 2010: prevention of stroke and systemic thromboembolism in atrial fibrillation and flutter. Can J Cardiol 2011;27(1):74-90.
25. Beasley B.N., Unger E.F., Temple R. Anticoagulant Options - Why FDA Approved a Higher but not a Lower Dose of Dabigatran. Engl J Med 2011; 364(19): 1788-90.
26. Wann L.S., Curtis A.B., Ellenbogen K.A., et al. 2011 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; 123: 1144-1150.
27. Pradaxa (dabigatran etexilate mesilate). Summary of opinion. EMA/CHMP/304146/2011. Committee for medicinal products for human use (CHMP). 14 April 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/000829/WC500105283.pdf . Date of access: 08.12.2011.
28. Pradaxa (dabigatran etexilate mesilate). EPAR summary for the public. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000829/WC500041060.pdf. Date of access: 08.12.2011.
29. European Medicines Agency updates on safety of Pradaxa. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2011/11/WC500117818.pdf. Date of access: 08.12.2011.
30. Wood S. Dabigatran: 260 fatal bleeds since approval worldwide. Available at: http://www.the-heart.org/article/1314809.doc. Date of access: 08.12.2011.
31. Pradaxa (dabigatran etexilate mesilate). Full prescribing information Availabe at: http://www.ac-cessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf. Date of access: 08.12.2011.
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For citations:
Yavelov I.S. DABIGATRAN ETEXILATE FOR PREVENTION OF CARDIOEMBOLIC COMPLICATIONS IN NONVALVULAR ATRIAL FIBRILLATION: HOW TO DO THE INTERVENTION MORE EFFECTIVE AND SAFER. Rational Pharmacotherapy in Cardiology. 2011;7(6):757-764. (In Russ.) https://doi.org/10.20996/1819-6446-2011-7-6-757-764
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