Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation

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Fältnamn	Indikatorer	Metadata
000		05057naa a2200505 4500
001		oai:DiVA.org:uu-304460
003		SwePub
008		161005s2016 \| \|\|\|\|\|\|\|\|\|\|\|000 \|\|eng\|
024	7	a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3044602 URI
024	7	a https://doi.org/10.1093/europace/euv3122 DOI
040		a (SwePub)uu
041		a engb eng
042		9 SwePub
072	7	a ref2 swepub-contenttype
072	7	a art2 swepub-publicationtype
100	1	a Ezekowitz, Michael D.u Thomas Jefferson Univ, Sidney Kimmel Med Coll, 1999 Sproul Rd, Philadelphia, PA 19107 USA.;Lankenau Med Ctr, Wynnewood, PA USA.4 aut
245	1 0	a Long-term evaluation of dabigatran 150 vs. 110 mg twice a day in patients with non-valvular atrial fibrillation
264		c 2016-03-03
264	1	b Oxford University Press (OUP),c 2016
338		a print2 rdacarrier
520		a 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.
650	7	a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kardiologi0 (SwePub)302062 hsv//swe
650	7	a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cardiac and Cardiovascular Systems0 (SwePub)302062 hsv//eng
653		a Atrial fibrillation
653		a Stroke
653		a Dabigatran etexilate
653		a Long-term outcome
700	1	a Eikelboom, Johnu McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.;Hamilton Hlth Sci, Hamilton, ON, Canada.4 aut
700	1	a Oldgren, Jonasu Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi4 aut0 (Swepub:uu)jonaoldg
700	1	a Reilly, Paul A.u Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT USA.4 aut
700	1	a Brueckmann, Martinau Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany.;Heidelberg Univ, Fac Med Mannheim, Mannheim, Germany.4 aut
700	1	a Kent, Anthony P.u Thomas Jefferson Univ, Sidney Kimmel Med Coll, 1999 Sproul Rd, Philadelphia, PA 19107 USA.4 aut
700	1	a Pogue, Janiceu McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.;Hamilton Hlth Sci, Hamilton, ON, Canada.4 aut
700	1	a Spahr, Judithu Lankenau Inst Med Res, Wynnewood, PA USA.4 aut
700	1	a Clemens, Andreasu Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany.4 aut
700	1	a Noack, Herbertu Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany.4 aut
700	1	a Diener, Hans-Christophu Univ Hosp Essen, Dept Neurol, Essen, Germany.4 aut
700	1	a Wallentin, Larsu Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi4 aut0 (Swepub:uu)larswall
700	1	a Yusuf, Salimu McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.;Hamilton Hlth Sci, Hamilton, ON, Canada.4 aut
700	1	a Connolly, Stuart J.u McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.;Hamilton Hlth Sci, Hamilton, ON, Canada.4 aut
710	2	a Thomas Jefferson Univ, Sidney Kimmel Med Coll, 1999 Sproul Rd, Philadelphia, PA 19107 USA.;Lankenau Med Ctr, Wynnewood, PA USA.b McMaster Univ, Populat Hlth Res Inst, Hamilton, ON, Canada.;Hamilton Hlth Sci, Hamilton, ON, Canada.4 org
773	0	t Europaced : Oxford University Press (OUP)g 18:7, s. 973-978q 18:7<973-978x 1099-5129x 1532-2092
856	4	u https://academic.oup.com/europace/article-pdf/18/7/973/24119643/euv312.pdf
856	4 8	u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-304460
856	4 8	u https://doi.org/10.1093/europace/euv312

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Av författaren/redakt...: Ezekowitz, Micha ...; Eikelboom, John; Oldgren, Jonas; Reilly, Paul A.; Brueckmann, Mart ...; Kent, Anthony P.; visa fler...; Pogue, Janice; Spahr, Judith; Clemens, Andreas; Noack, Herbert; Diener, Hans-Chr ...; Wallentin, Lars; Yusuf, Salim; Connolly, Stuart ...; visa färre...

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