دورية أكاديمية
A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder
| العنوان: | A randomised, double-blind, parallel design, multi-institutional, non-inferiority phase IV trial of imidafenacin versus fesoterodine for overactive bladder |
|---|---|
| المساهمون: | K.-S. Lee, B. Park, J. H. Kim, H. G. Kim, J. T. Seo, J. G. Lee, Y. Jang, M.-S. Choo, Kim, Jang Hwan |
| سنة النشر: | 2013 |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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 �돟 3 months, daily mean voiding frequency (DMVF) �돟 8, and daily mean urgency or urgency incontinence frequency �돟 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 짹 3.63 and -2.45 짹 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. ; open |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| تدمد: | 1368-5031 1742-1241 |
| العلاقة: | INTERNATIONAL JOURNAL OF CLINICAL PRACTICE; J01099; OAK-2013-02288; https://ir.ymlib.yonsei.ac.kr/handle/22282913/88404Test; T201303951; INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Vol.67(12) : 1317-1326, 2013 |
| DOI: | 10.1111/ijcp.12272 |
| DOI: | 10.1111/ijcp.12272/abstract |
| الإتاحة: | https://doi.org/10.1111/ijcp.12272Test https://ir.ymlib.yonsei.ac.kr/handle/22282913/88404Test |
| حقوق: | CC BY-NC-ND 2.0 KR ; https://creativecommons.org/licenses/by-nc-nd/2.0/krTest/ ; not free |
| رقم الانضمام: | edsbas.30291790 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 13685031 17421241 |
|---|---|
| DOI: | 10.1111/ijcp.12272 |