Learning the Respective Roles of Warfarin and Dabigatran to Prevent Stroke in Patients With Nonvalvular Atrial Fibrillation

Editorials15 November 2011Learning the Respective Roles of Warfarin and Dabigatran to Prevent Stroke in Patients With Nonvalvular Atrial FibrillationRebecca J. Beyth, MD and C. Seth Landefeld, MDRebecca J. Beyth, MDFrom North Florida/South Georgia Veterans Health System and University of Florida, Gainesville, FL 32608-1197; and University of California, San Francisco, and San Francisco Veterans Affairs Medical Center, San Francisco, CA 94118.Search for more papers by this author and C. Seth Landefeld, MDFrom North Florida/South Georgia Veterans Health System and University of Florida, Gainesville, FL 32608-1197; and University of California, San Francisco, and San Francisco Veterans Affairs Medical Center, San Francisco, CA 94118.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-155-10-201111150-00012 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In “the race to replace warfarin,” the direct thrombin inhibitor dabigatran was the first off the starting block (1). In October 2010, the U.S. Food and Drug Administration (FDA) approved oral dabigatran at a dosage of 150 mg twice daily to reduce the risk for stroke and systemic embolism in persons with nonvalvular atrial fibrillation (2). This approval was largely based on results from the RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) trial, which showed that the rates of stroke or systemic embolism and death each decreased by 0.5% per year with dabigatran, 150 mg twice daily, compared with adjusted-dose ...References1. Singer N. The race to replace warfarin. NYTimes.com Prescription Blog. 31 August 2010. Accessed at prescriptions.blogs.nytimes.com/2010/08/31/the-race-to-replace-warfarin/?scp=3&sq=dabigatran&st=cse on 4 October 2011. Google Scholar2. U.S. Food and Drug Administration. FDA approves Pradaxa to prevent stroke in people with atrial fibrillation [news release]. 19 October 2010. Accessed at www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230241.htm on 4 October 2011. Google Scholar3. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51. [PMID: 19717844] CrossrefMedlineGoogle Scholar4. Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011;123:2562-70. [PMID: 21606397] CrossrefMedlineGoogle Scholar5. Singer DE, Chang Y, Fang MC, Borowsky LH, Pomernacki NK, Udaltsova N, et al. The net clinical benefit of warfarin anticoagulation in atrial fibrillation. Ann Intern Med. 2009;151:297-305. [PMID: 19721017] LinkGoogle Scholar6. Singer DE, Albers GW, Dalen JE, Fang MC, Go AS, Halperin JL, et al; American College of Chest Physicians. Antithrombotic therapy in atrial fibrillation: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:546S-592S. [PMID: 18574273] CrossrefMedlineGoogle Scholar7. Go AS, Hylek EM, Chang Y, Phillips KA, Henault LE, Capra AM, et al. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003;290:2685-92. [PMID: 14645310] CrossrefMedlineGoogle Scholar8. Fleming TR, Emerson SS. Evaluating rivaroxaban for nonvalvular atrial fibrillation—regulatory considerations. N Engl J Med. 2011;365:1557-9. [PMID: 21992495] CrossrefMedlineGoogle Scholar9. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-92. [PMID: 21870978] CrossrefMedlineGoogle Scholar10. Oldgren J, Alings M, Darius H, Diener HC, Eikelboom J, Ezekowitz MD, et al. Risks for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: a subgroup analysis of the RE-LY trial. Ann Intern Med. 2011;155:660-7. LinkGoogle Scholar11. Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285:2864-70. [PMID: 11401607] CrossrefMedlineGoogle Scholar12. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren 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. [PMID: 21576658] CrossrefMedlineGoogle Scholar13. Schulman S, Parpia S, Stewart C, Rudd-Scott L, Julian JA, Levine M. Warfarin dose assessment every 4 weeks versus every 12 weeks in patients with stable international normalized ratios. A randomized trial. Ann Intern Med. 2011;155:653-9. LinkGoogle Scholar Author, Article, and Disclosure InformationAffiliations: From North Florida/South Georgia Veterans Health System and University of Florida, Gainesville, FL 32608-1197; and University of California, San Francisco, and San Francisco Veterans Affairs Medical Center, San Francisco, CA 94118.Disclosures: Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2436.Corresponding Author: C. Seth Landefeld, MD, Division of Geriatrics, University of California, San Francisco, Suite 380, 3333 California Street, San Francisco, CA 94118.Current Author Addresses: Dr. Beyth: Division of Geriatrics, University of Florida, 1601 Southwest Archer Road, Gainesville, FL 32608-1197.Dr. Landefeld: Division of Geriatrics, University of California, San Francisco, Suite 380, 3333 California Street, San Francisco, CA 94118. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoWarfarin Dose Assessment Every 4 Weeks Versus Every 12 Weeks in Patients With Stable International Normalized Ratios Sam Schulman , Sameer Parpia , Clare Stewart , Lisa Rudd-Scott , Jim A. Julian , and Mark Levine Risks for Stroke, Bleeding, and Death in Patients With Atrial Fibrillation Receiving Dabigatran or Warfarin in Relation to the CHADS2 Score: A Subgroup Analysis of the RE-LY Trial Jonas Oldgren , Marco Alings , Harald Darius , Hans-Christoph Diener , John Eikelboom , Michael D. Ezekowitz , Gabriel Kamensky , Paul A. Reilly , Sean Yang , Salim Yusuf , Lars Wallentin , Stuart J. Connolly , and Metrics Cited byImpact of warfarin discharge education program on hospital readmission and treatment costsRevisión de los resultados de los principales subestudios del estudio RE-LY 15 November 2011Volume 155, Issue 10Page: 714-715KeywordsAnticoagulant therapyAtrial fibrillationFood and Drug AdministrationGeriatricsHemorrhageInternational normalized ratioMortalitySafetyStrokeThrombin ePublished: 15 November 2011 Issue Published: 15 November 2011 Copyright & PermissionsCopyright © 2011 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...