A Thorough Electrocardiogram Study of Edoxaban, a Novel Factor Xa Inhibitor
2011; Wiley; Volume: 51; Issue: 8 Linguagem: Inglês
10.1177/0091270010381901
ISSN1552-4604
AutoresJeanne Mendell, R. Basavapathruni, Dennis Swearingen, Andrew H. Draves, G. Zhang, Joel Morganroth,
Tópico(s)Cardiac Arrhythmias and Treatments
ResumoThe Journal of Clinical PharmacologyVolume 51, Issue 8 p. 1241-1246 A Thorough Electrocardiogram Study of Edoxaban, a Novel Factor Xa Inhibitor Dr J. Mendell MPH, PhD, Corresponding Author Dr J. Mendell MPH, PhD Daiichi Sankyo Pharma Development, Edison, New Jersey Address for correspondence: Jeanne Mendell, MPH, PhD, Daiichi Sankyo Pharma Development, 399 Thornall St, Edison, NJ 08837; e-mail: [email protected].Search for more papers by this authorMs R. Basavapathruni MSPH, Ms R. Basavapathruni MSPH Daiichi Sankyo Pharma Development, Edison, New JerseySearch for more papers by this authorDr D. Swearingen MD, Dr D. Swearingen MD Celerion, Inc., Tempe, ArizonaSearch for more papers by this authorMs A. Draves, Ms A. Draves Celerion, Inc., Tempe, ArizonaSearch for more papers by this authorDr G. Zhang PhD, Dr G. Zhang PhD Daiichi Sankyo Pharma Development, Edison, New JerseySearch for more papers by this authorDr J. Morganroth MD, Dr J. Morganroth MD ERT, Philadelphia, Pennsylvania.Search for more papers by this author Dr J. Mendell MPH, PhD, Corresponding Author Dr J. Mendell MPH, PhD Daiichi Sankyo Pharma Development, Edison, New Jersey Address for correspondence: Jeanne Mendell, MPH, PhD, Daiichi Sankyo Pharma Development, 399 Thornall St, Edison, NJ 08837; e-mail: [email protected].Search for more papers by this authorMs R. Basavapathruni MSPH, Ms R. Basavapathruni MSPH Daiichi Sankyo Pharma Development, Edison, New JerseySearch for more papers by this authorDr D. Swearingen MD, Dr D. Swearingen MD Celerion, Inc., Tempe, ArizonaSearch for more papers by this authorMs A. Draves, Ms A. Draves Celerion, Inc., Tempe, ArizonaSearch for more papers by this authorDr G. Zhang PhD, Dr G. Zhang PhD Daiichi Sankyo Pharma Development, Edison, New JerseySearch for more papers by this authorDr J. Morganroth MD, Dr J. Morganroth MD ERT, Philadelphia, Pennsylvania.Search for more papers by this author First published: 07 March 2013 https://doi.org/10.1177/0091270010381901Citations: 10 Supplementary data for this article are available at http:jcp.sagepub.comsupplemental. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat REFERENCES 1 Zafar MU, Vorchheimer DA, Gaztanaga J, et al. Antithrombotic effects of factor Xa inhibition with DU-176b: Phase-I study of an oral, direct factor Xa inhibitor using an ex-vivo flow chamber. Thromb Haemost. 2007; 98: 883–888. 2 Furugohri T, Isobe K, Honda Y, et al. DU-176b, a potent and orally active factor Xa inhibitor: in vitro and in vivo pharmacological profiles. J Thromb Haemost. 2008; 6: 1542–1549. 3 Ogata K, Mendell-Harary J, Tachibana M, et al. Clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of the novel Factor Xa inhibitor edoxaban in healthy volunteers. J Clin Pharm 2010; 50: 743–753. 4 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. The Clinical Evaluation of QT/QTC interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs E14. Geneva, Switzerland (2005). http:www.ich.orgLOBmediaMEDIA1476.pdf. Accessed December 19, 2009. 5 Morganroth J. Cardiac repolarization and the safety of new drugs defined by electrocardiography. Clin Pharmacol Ther. 2007; 81: 108–103. 6 Ruff CT, Giugliano RP, Antman EM, et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: Design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010; 160: 635–642. 7 Weitz JI, Connolly SJ, Patel I, et al. Randomized, parallel-group, multicenter, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation. Thromb Haemost. 2010; 104: 633–641. 8 Bloomfield DM, Kost JT, Ghosh K, et al. The effect of moxifloxacin on QTc and implications for the design of thorough QT studies. Clin Pharmacol Ther. 2008; 84: 475–480. 9 World Medical Association. Declaration of Helsinki. 52nd WMA General Assembly. Edinburgh, Scotland, October 2000. 10 Rohatagi S, Carrothers TJ, Kuwabara-Wagg J, Khariton TY. Is a thorough QTC study necessary' The role of modeling and simulation in evaluating the QTc prolongation potential of drugs. J Clin Pharmacol. 2009; 49: 1284–1296. Citing Literature Volume51, Issue8August 2011Pages 1241-1246 ReferencesRelatedInformation
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