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A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder

Authors
 K.-S. Lee  ;  B. Park  ;  J. H. Kim  ;  H. G. Kim  ;  J. T. Seo  ;  J. G. Lee  ;  Y. Jang  ;  M.-S. Choo 
Citation
 INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Vol.67(12) : 1317-1326, 2013 
Journal Title
 INTERNATIONAL JOURNAL OF CLINICAL PRACTICE 
ISSN
 1368-5031 
Issue Date
2013
MeSH
Analysis of Variance ; Benzhydryl Compounds/administration & dosage* ; Benzhydryl Compounds/adverse effects ; Double-Blind Method ; Drug Administration Schedule ; Female ; Health Status ; Humans ; Imidazoles/administration & dosage* ; Imidazoles/adverse effects ; Male ; Middle Aged ; Muscarinic Antagonists/administration & dosage* ; Muscarinic Antagonists/adverse effects ; Treatment Outcome ; Urinary Bladder, Overactive/drug therapy* ; Urological Agents
Keywords
Analysis of Variance ; Benzhydryl Compounds/administration & dosage* ; Benzhydryl Compounds/adverse effects ; Double-Blind Method ; Drug Administration Schedule ; Female ; Health Status ; Humans ; Imidazoles/administration & dosage* ; Imidazoles/adverse effects ; Male ; Middle Aged ; Muscarinic Antagonists/administration & dosage* ; Muscarinic Antagonists/adverse effects ; Treatment Outcome ; Urinary Bladder, Overactive/drug therapy* ; Urological Agents
Abstract
AIMS: Our objective was to compare the efficacy and safety of imidafenacin over fesoterodine in patients with overactive bladder (OAB). METHODS: This study is a randomised, double-blind, parallel-group, fesoterodine-controlled study in patients with continuous OAB symptoms for ≥ 3 months, daily mean voiding frequency (DMVF) ≥ 8, and daily mean urgency or urgency incontinence frequency ≥ 2. A twice-daily 0.1 mg imidafenacin with placebo, or once-daily 4 mg fesoterodine with placebo were administered for 12 weeks. The primary efficacy end-point was the difference in DMVF at 12 weeks. The secondary efficacy end-points were differences in daily mean: (i) voiding frequency at 4 and 8 weeks; (ii) urgency frequency; (iii) urgency incontinence frequency; (iv) incontinence frequency; (v) nocturia frequency; and (vi) quality of life score. The variables for safety analysis were adverse events, vital signs, residual urine volume and clinical laboratory tests. An efficacy analysis was conducted in per-protocol patients and the safety analysis was conducted in all randomised patients. RESULTS: The differences in DMVF at 12 weeks were -3.38 ± 3.63 and -2.45 ± 3.73 in the imidafenacin and fesoterodine groups, respectively, and the difference was not significant between the two groups. Imidafenacin was non-inferior to fesoterodine, and the lower limit of 95% two-sided confidence intervals was -0.53. The other six secondary end-points and variables for safety analysis showed no difference between the two groups. CONCLUSIONS: Imidafenacin was non-inferior to fesoterodine in terms of efficacy, and showed no significant difference in terms of safety.
Full Text
http://onlinelibrary.wiley.com/doi/10.1111/ijcp.12272/abstract
DOI
10.1111/ijcp.12272
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Jang Hwan(김장환) ORCID logo https://orcid.org/0000-0002-9056-7072
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/88404
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