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Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation
Thomas Jefferson Univ, Sidney Kimmel Med Coll, 1999 Sproul Rd, Philadelphia, PA 19107 USA.;Lankenau Med Ctr, Wynnewood, PA USA..
McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.;Hamilton Hlth Sci, Hamilton, ON, Canada..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT USA..
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2016 (English)In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 18, no 7, 973-978 p.Article in journal (Refereed) Published
Abstract [en]

Aims The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial allowed patients who completed the trial receiving their assigned dabigatran 150 mg (D150) or 110 mg (D110) twice a day to continue into the Long-term Multicenter Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) trial. This permitted assessment of outcomes over a median of 4.6 and a maximum of 6.7 years, respectively. Methods and results The analysed population included only those patients who completed RE-LY on dabigatran and continued into RELYABLE without interruption of assigned dabigatran. Cumulative risk was expressed as Kaplan-Meier plots. Outcomes were compared using Cox proportional hazard modelling. Stroke or systemic embolization rates were 1.25 and 1.54% per year (D150 and D110, respectively); hazard ratio (HR) 0.81 [95% confidence interval (CI): 0.68-0.96] (P = 0.02). Ischaemic stroke was 1.03 (D150) and 1.29%/year (D110); HR 0.79 (95% CI: 0.66-0.95) (P = 0.01). Haemorrhagic stroke rates were 0.11 (D150) and 0.13%/year (D110); HR 0.91 (95% CI: 0.51-1.62) (P = 0.75). Rates of major haemorrhage were 3.34 (D150) and 2.76%/year (D110); HR 1.22 (95% CI: 1.08-1.37) (P = 0.0008). Intracranial haemorrhage rates were 0.32 (D150) and 0.23%/year (D110); HR 1.37 (95% CI: 0.93-2.01) (P = 0.11). Mortality was 3.43 (D150) and 3.55%/year (D110); HR 0.97 (95% CI: 0.87-1.08) (P = 0.54). Conclusion Annualized rates of all outcomes were constant with better efficacy of D150, less major bleeding with D110, and low intracerebral haemorrhage rates for both doses. There were no additional safety concerns. This is the longest continuous randomized experience of a novel anticoagulant.

Place, publisher, year, edition, pages
2016. Vol. 18, no 7, 973-978 p.
Keyword [en]
Atrial fibrillation, Stroke, Dabigatran etexilate, Long-term outcome
National Category
Cardiac and Cardiovascular Systems
URN: urn:nbn:se:uu:diva-304460DOI: 10.1093/europace/euv312ISI: 000382056100004PubMedID: 26944733OAI: oai:DiVA.org:uu-304460DiVA: diva2:1032941
AstraZenecaGlaxoSmithKline (GSK)German Research Foundation (DFG)EU, European Research CouncilNIH (National Institute of Health)
Available from: 2016-10-05 Created: 2016-10-05 Last updated: 2016-10-05Bibliographically approved

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