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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
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
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2011 (English)In: Circulation, ISSN 0009-7322, E-ISSN 1524-4539, Vol. 123, no 21, 2363-2372 p.Article in journal (Refereed) Published
Abstract [en]

Background-Dabigatran 150 and 110 mg twice a day and warfarin are effective for stroke prevention in atrial fibrillation. The purpose of this study was to compare their risks of bleeding in the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial. Methods and Results-The RE-LY trial randomized 18 113 patients to receive dabigatran 110 or 150 mg twice a day or warfarin dose adjusted to an international normalized ratio of 2.0 to 3.0 for a median follow-up of 2.0 years. Compared with warfarin, dabigatran 110 mg twice a day was associated with a lower risk of major bleeding (2.87% versus 3.57%; P=0.002), whereas dabigatran 150 mg twice a day was associated with a similar risk of major bleeding (3.31% versus 3.57%; P=0.32). There was a significant treatment-by-age interaction, such that dabigatran 110 mg twice a day compared with warfarin was associated with a lower risk of major bleeding in patients aged = 75 years (4.43% versus 4.37%; P=0.89; P for interaction = 75 years (5.10% versus 4.37%; P=0.07; P for interaction = 75 years, intracranial bleeding risk is lower but extracranial bleeding risk is similar or higher with both doses of dabigatran compared with warfarin.

Place, publisher, year, edition, pages
2011. Vol. 123, no 21, 2363-2372 p.
Keyword [en]
anticoagulants, atrial fibrillation
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-154914DOI: 10.1161/CIRCULATIONAHA.110.004747ISI: 000291104000010PubMedID: 21576658OAI: oai:DiVA.org:uu-154914DiVA: diva2:422522
Available from: 2011-06-13 Created: 2011-06-13 Last updated: 2017-12-11Bibliographically approved

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Wallentin, LarsOldgren, Jonas

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