Treatment outcomes in the STAR study: A subanalysis of solifenacin 5 mg and tolterodine ER 4 mg

被引:58
作者
Chapple, Christopher R.
Fianu-Jonsson, Aino
Indig, Mark
Khullar, Vik
Rosa, Jose
Scarpa, Roberto M.
Mistry, Arun
Wright, D. Mark
Bolodeoku, John
机构
[1] Royal Hallamshire Hosp, Urol Res Off, Sheffield S10 2JF, S Yorkshire, England
[2] Karolinska Univ Sjukhuset Hudd, Enheten Obstet & Gynekol, Stockholm, Sweden
[3] St Marys Hosp, Dept Obstet & Gynaecol, London, England
[4] Hosp Comarcal Santiago Apostol, Dept Urol, Miranda De Ebro Burgos, Spain
[5] Univ Turin, Urol Clin, ASO S Luigi Gonzaga, Urol Clin, Turin, Italy
[6] Astellas Pharma Europe Ltd, Med Affairs Europe, Staines, England
关键词
antimuscarinic; solifenacin; tolterodine; overactive bladder;
D O I
10.1016/j.eururo.2007.05.027
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Objective: To compare CAB symptom outcomes following initial randomised treatment with solifenacin 5 mg or tolterodine ER 4 mg at the 4-week clinic-visit and again at 12 weeks for patients choosing to remain on this treatment dose from 4 weeks. Methods: A prospective, double blind, double-dummy, two-arm, parallel-group, 12-week study (The STAR study) was conducted to compare the efficacy and safety of solifenacin 5/10 mg and tolterodine extended release (ER) 4 mg in OAB patients. Results: At 4 weeks mean improvements in CAB symptoms, including urgency, frequency (primary variable), incontinence and nocturia, were larger in patients randomised to solifenacin 5 mg; with the difference for incontinence being statistically significant (mean reduction in incontinence episodes/24 hrs in the solifenacin group of -1.30 vs. -0.90 (p = 0.0181); the mean result for solifenacin 5 mg amounted to a 44% additional improvement.) There was an associated significant reduction in pad use (reduced by -1.21 vs. -0.80; p = 0.0089); the mean result for solifenacin 5 mg amounted to a 51% additional improvement over that of tolterodine ER 4 mg. For patients choosing to remain on these treatments improvements in favour of solifenacin were maintained at study end (12-weeks). Treatments were well tolerated. Conclusions: Within 4 weeks solifenacin 5 mg was statistically significantly better than tolterodine ER 4 mg in improving incontinence and reducing incontinence pad use. Differences in efficacy in favour of solifenacin 5 mg were maintained from 4 weeks for the duration of the study for patients choosing to remain on their starting dose. (c) 2007 European Association of Urology. Published by Elsevier B.V. All rights reserved.
引用
收藏
页码:1195 / 1203
页数:9
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