A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder
DC Field | Value | Language |
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dc.contributor.author | Lee, K. -S. | - |
dc.contributor.author | Park, B. | - |
dc.contributor.author | Kim, J. H. | - |
dc.contributor.author | Kim, H. G. | - |
dc.contributor.author | Seo, J. T. | - |
dc.contributor.author | Lee, J. G. | - |
dc.contributor.author | Jang, Y. | - |
dc.contributor.author | Choo, M. -S. | - |
dc.date.accessioned | 2021-09-05T18:22:42Z | - |
dc.date.available | 2021-09-05T18:22:42Z | - |
dc.date.created | 2021-06-15 | - |
dc.date.issued | 2013-12 | - |
dc.identifier.issn | 1368-5031 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/101441 | - |
dc.description.abstract | AimsOur objective was to compare the efficacy and safety of imidafenacin over fesoterodine in patients with overactive bladder (OAB). MethodsThis study is a randomised, double-blind, parallel-group, fesoterodine-controlled study in patients with continuous OAB symptoms for 3months, daily mean voiding frequency (DMVF) 8, and daily mean urgency or urgency incontinence frequency 2. A twice-daily 0.1mg imidafenacin with placebo, or once-daily 4mg fesoterodine with placebo were administered for 12weeks. The primary efficacy end-point was the difference in DMVF at 12weeks. The secondary efficacy end-points were differences in daily mean: (i) voiding frequency at 4 and 8weeks; (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. ResultsThe differences in DMVF at 12weeks were -3.383.63 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. ConclusionsImidafenacin was non-inferior to fesoterodine in terms of efficacy, and showed no significant difference in terms of safety. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.subject | QUALITY-OF-LIFE | - |
dc.subject | TOLTERODINE EXTENDED-RELEASE | - |
dc.subject | HEAD-TO-HEAD | - |
dc.subject | ANTIMUSCARINIC AGENT | - |
dc.subject | RECEPTOR SUBTYPES | - |
dc.subject | JAPANESE PATIENTS | - |
dc.subject | SYMPTOMS | - |
dc.subject | EFFICACY | - |
dc.subject | CAPACITY | - |
dc.title | A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Lee, J. G. | - |
dc.identifier.doi | 10.1111/ijcp.12272 | - |
dc.identifier.scopusid | 2-s2.0-84888050120 | - |
dc.identifier.wosid | 000330102700017 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, v.67, no.12, pp.1317 - 1326 | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF CLINICAL PRACTICE | - |
dc.citation.title | INTERNATIONAL JOURNAL OF CLINICAL PRACTICE | - |
dc.citation.volume | 67 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 1317 | - |
dc.citation.endPage | 1326 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | General & Internal Medicine | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Medicine, General & Internal | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | QUALITY-OF-LIFE | - |
dc.subject.keywordPlus | TOLTERODINE EXTENDED-RELEASE | - |
dc.subject.keywordPlus | HEAD-TO-HEAD | - |
dc.subject.keywordPlus | ANTIMUSCARINIC AGENT | - |
dc.subject.keywordPlus | RECEPTOR SUBTYPES | - |
dc.subject.keywordPlus | JAPANESE PATIENTS | - |
dc.subject.keywordPlus | SYMPTOMS | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordPlus | CAPACITY | - |
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