HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:
Sign In to gain access to subscriptions and/or personal tools.

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Request Reprints Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (13) Citing Articles via Google Scholar Google Scholar Articles by Serra, D. B. Articles by Wang, Y. Search for Related Content PubMed PubMed Citation Articles by Serra, D. B. Articles by Wang, Y. Social Bookmarking                         What's this?

QT and QTc Interval With Standard and Supratherapeutic Doses of Darifenacin, a Muscarinic M₃ Selective Receptor Antagonist for the Treatment of Overactive Bladder

From Exploratory Clinical Development, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.

Prolongation of QT interval on an electrocardiogram is a valuable predictor of a drug's ability to cause potentially fatal ventricular tachyarrhythmia (torsades de pointes). Darifenacin is a muscarinic M₃ selective receptor antagonist developed for the treatment of overactive bladder, a debilitating condition that is particularly prevalent in the older population. This 7-day, randomized, parallel-group study (n = 188) measured QT/QTc interval in healthy volunteers receiving once-daily darifenacin at steady-state therapeutic (15 mg) and supratherapeutic (75 mg) doses, alongside controls receiving placebo or moxifloxacin (positive control, 400 mg) once daily. There was no significant increase in QTcF interval with darifenacin treatment compared with placebo. Mean changes from baseline at pharmacokinetic T_max versus placebo were -0.4 and -2.2 milliseconds in the darifenacin 15 mg and 75 mg groups, respectively, compared with +11.6 milliseconds in the moxifloxacin group (P < .01). This study demonstrates that darifenacin does not prolong QT/QTc interval.

Key Words: Darifenacin • overactive bladder • QT interval • cardiac repolarization

Address for reprints: Denise B. Serra, Exploratory Clinical Development, 435/1159, One Health Plaza, East Hanover, NJ 07936-1080.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				D. M. Bloomfield, R. Krishna, D. Hreniuk, L. Hickey, K. Ghosh, A. J. Bergman, J. Miller, M. J. Gutierrez, R. Stoltz, K. M. Gottesdiener, et al. A Thorough QTc Study to Assess the Effect of Sitagliptin, a DPP4 Inhibitor, on Ventricular Repolarization in Healthy Subjects J. Clin. Pharmacol., August 1, 2009; 49(8): 937 - 946. [Abstract] [Full Text] [PDF]

				S. Ayalasomayajula, C.-M. Yeh, S. Vaidyanathan, B. Flannery, H. A. Dieterich, D. Howard, M. P. Bedigian, and W. P. Dole Effects of Aliskiren, a Direct Renin Inhibitor, on Cardiac Repolarization and Conduction in Healthy Subjects J. Clin. Pharmacol., July 1, 2008; 48(7): 799 - 811. [Abstract] [Full Text] [PDF]

				M. Iwamoto, J. T. Kost, G. C. Mistry, L. A. Wenning, S. A. Breidinger, T. C. Marbury, J. A. Stone, K. M. Gottesdiener, D. M. Bloomfield, and J. A. Wagner Raltegravir Thorough QT/QTc Study: A Single Supratherapeutic Dose of Raltegravir Does Not Prolong the QTcF Interval J. Clin. Pharmacol., June 1, 2008; 48(6): 726 - 733. [Abstract] [Full Text] [PDF]