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Article: Safety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation

TitleSafety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillation
Authors
Issue Date2011
PublisherSchattauer GmbH. The Journal's web site is located at http://www.thrombosis-online.com
Citation
Thrombosis and Haemostasis, 2011, v. 105 n. 3, p. 535-544 How to Cite?
AbstractEdoxaban is an oral, reversible, direct factor Xa inhibitor in phase III clinical development for the prevention of stroke in atrial fibrillation (AF). A phase II study was undertaken to evaluate the safety and efficacy of edoxaban in Asian patients with non-valvular AF with CHADS2 score >/=1. In a multicentre, active-controlled, double-blind edoxaban and open-label warfarin, parallel-group study, a total of 235 patients from four Asian countries were randomly assigned to edoxaban 30 mg qd, 60 mg qd or warfarin dose adjusted to international normalised ratio of 2-3 for three months. The primary endpoint was the incidence of centrally adjudicated all bleeding events (major, clinically relevant non-major and minor). Secondary endpoints included thromboembolic events, biomarkers of thrombus formation and all adverse events (AEs). The incidence of all bleeding events (95% CI) was 20.3% (12.9, 30.4) for edoxaban 30 mg, 23.8% (15.8, 34.1) for edoxaban 60 mg, and 29.3% (20.2, 40.4) for warfarin. A subgroup analysis suggested low body weight (
Persistent Identifierhttp://hdl.handle.net/10722/135227
ISSN
2015 Impact Factor: 5.255
2015 SCImago Journal Rankings: 2.089
ISI Accession Number ID
Funding AgencyGrant Number
Daiichi Sankyo Co., Ltd., Tokyo, Japan
Daiichi Sankyo Co., Ltd.
Funding Information:

This study was funded by Daiichi Sankyo Co., Ltd., Tokyo, Japan.

 

DC FieldValueLanguage
dc.contributor.authorChung, Nen_US
dc.contributor.authorJeon, HKen_US
dc.contributor.authorLien, LMen_US
dc.contributor.authorLai, WTen_US
dc.contributor.authorTse, HFen_US
dc.contributor.authorChung, WSen_US
dc.contributor.authorLee, THen_US
dc.contributor.authorChen, SA-
dc.date.accessioned2011-07-27T01:30:17Z-
dc.date.available2011-07-27T01:30:17Z-
dc.date.issued2011en_US
dc.identifier.citationThrombosis and Haemostasis, 2011, v. 105 n. 3, p. 535-544en_US
dc.identifier.issn0340-6245-
dc.identifier.urihttp://hdl.handle.net/10722/135227-
dc.description.abstractEdoxaban is an oral, reversible, direct factor Xa inhibitor in phase III clinical development for the prevention of stroke in atrial fibrillation (AF). A phase II study was undertaken to evaluate the safety and efficacy of edoxaban in Asian patients with non-valvular AF with CHADS2 score >/=1. In a multicentre, active-controlled, double-blind edoxaban and open-label warfarin, parallel-group study, a total of 235 patients from four Asian countries were randomly assigned to edoxaban 30 mg qd, 60 mg qd or warfarin dose adjusted to international normalised ratio of 2-3 for three months. The primary endpoint was the incidence of centrally adjudicated all bleeding events (major, clinically relevant non-major and minor). Secondary endpoints included thromboembolic events, biomarkers of thrombus formation and all adverse events (AEs). The incidence of all bleeding events (95% CI) was 20.3% (12.9, 30.4) for edoxaban 30 mg, 23.8% (15.8, 34.1) for edoxaban 60 mg, and 29.3% (20.2, 40.4) for warfarin. A subgroup analysis suggested low body weight (</=60 kg) may affect the incidence of bleeding events with edoxaban. The incidence of study drug-related AEs was 22% for edoxaban 30 mg, 29% for edoxaban 60 mg and 33% for warfarin. No thromboembolic events occurred in any treatment group. In conclusion, this phase II study found a trend for a reduction in the incidence of all bleeding events in Asian AF patients with edoxaban 30 mg and 60 mg compared with warfarin. Adverse events were similar between the edoxaban 60-mg and warfarin groups and were lower with the edoxaban 30-mg group. © Schattauer 2011.-
dc.languageengen_US
dc.publisherSchattauer GmbH. The Journal's web site is located at http://www.thrombosis-online.com-
dc.relation.ispartofThrombosis and Haemostasisen_US
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.subject.meshAnticoagulants - administration and dosage-
dc.subject.meshAtrial Fibrillation - drug therapy - pathology-
dc.subject.meshFactor Xa - antagonists and inhibitors - metabolism-
dc.subject.meshPyridines - administration and dosage-
dc.subject.meshThiazoles - administration and dosage-
dc.titleSafety of edoxaban, an oral factor Xa inhibitor, in Asian patients with non-valvular atrial fibrillationen_US
dc.typeArticleen_US
dc.identifier.emailTse, HF: hftse@hkucc.hku.hken_US
dc.identifier.authorityTse, HF=rp00428en_US
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1160/TH10-07-0451-
dc.identifier.pmid21136011-
dc.identifier.scopuseid_2-s2.0-79952513881-
dc.identifier.hkuros187305en_US
dc.identifier.volume105en_US
dc.identifier.issue3-
dc.identifier.spage535en_US
dc.identifier.epage544en_US
dc.identifier.isiWOS:000288627000020-

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