University Hospital Maastricht, the Netherlands.
Int J Clin Pract. 2010 Apr;64(5):584-93. doi: 10.1111/j.1742-1241.2010.02361.x. Epub 2010 Feb 19.
The aim of this study was to assess the long-term safety, tolerability and efficacy of fesoterodine treatment in subjects with overactive bladder (OAB) symptoms.
This was an open-label extension study of a 12-week, double-blind fesoterodine study. During open-label treatment, all subjects received fesoterodine 8 mg for an initial 4 weeks, after which subjects could elect dose reduction to 4 mg or subsequent reescalation to 8 mg during clinic visits (dose reduction and reescalation each permitted once annually). The maximum allowable duration of open-label fesoterodine treatment ranged from 24 to 32 months across study sites. Safety and tolerability were evaluated via discontinuations, fesoterodine exposure, treatment-emergent adverse events (TEAEs) and subject-reported treatment tolerance. Three-day bladder diaries and other patient-reported outcomes (PROs) were assessed during the first 24 months of open-label treatment. PROs included evaluations of health-related quality of life [HRQL; King's Health Questionnaire (KHQ), and International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)], severity of bladder-related problems and treatment satisfaction. Subjects completed 3-day diaries before open-label baseline and months 1, 4, 8, 12 and 24; the ICIQ-SF and measures of bladder-related problems and treatment satisfaction at open-label baseline and months 4, 12 and 24; and the KHQ at open-label baseline and months 12 and 24.
Of the 417 eligible subjects who enrolled in the open-label extension, 61% continued fesoterodine treatment for > or = 24 months and 71% elected to maintain the fesoterodine 8-mg dose throughout treatment. No unexpected safety signals were observed. Most subjects rated treatment tolerance as at least 'good' throughout the study (> or = 88%). Dry mouth was the most commonly reported TEAE (34%) during open-label treatment, resulting in discontinuation in 2% of subjects (n = 8). Improvements from open-label baseline in OAB symptoms, HRQL and bladder-related problems were statistically significant at the earliest point measured and maintained through month 24. Treatment satisfaction rates were high throughout the study (> or = 84%).
Long-term fesoterodine treatment was well tolerated and associated with sustained improvements in OAB symptoms and HRQL.
本研究旨在评估索利那新治疗膀胱过度活动症（OAB）患者的长期安全性、耐受性和疗效。
这是一项为期 12 周、双盲索利那新研究的开放性扩展研究。在开放性治疗期间，所有患者接受索利那新 8mg 治疗，初始 4 周，之后患者可选择减少剂量至 4mg 或在就诊时重新增加剂量至 8mg（每年各允许一次剂量减少和增加）。各研究地点的开放性索利那新治疗的最长允许时间范围为 24 至 32 个月。通过停药、索利那新暴露、治疗中出现的不良事件（TEAE）和患者报告的治疗耐受性来评估安全性和耐受性。在开放性治疗的前 24 个月中，通过 3 天膀胱日记和其他患者报告的结局（PRO）进行评估。PRO 包括健康相关生活质量评估[HRQL；King's 健康问卷（KHQ）和国际尿失禁咨询问卷-短表（ICIQ-SF）]、膀胱相关问题严重程度和治疗满意度。患者在开放性基线前和第 1、4、8、12 和 24 个月完成 3 天日记；在开放性基线和第 4、12 和 24 个月完成 ICIQ-SF 和膀胱相关问题及治疗满意度的评估；在开放性基线和第 12 和 24 个月完成 KHQ。
在符合开放性扩展条件的 417 例合格患者中，61%的患者继续接受索利那新治疗≥24 个月，71%的患者选择在整个治疗过程中维持索利那新 8mg 剂量。未观察到意外的安全性信号。大多数患者在整个研究中（≥88%）均至少将治疗耐受性评为“良好”。在开放性治疗期间，口干是最常报告的不良事件（34%），导致 2%的患者（n=8）停药。与开放性基线相比，OAB 症状、HRQL 和膀胱相关问题在最早测量的时间点出现统计学意义上的显著改善，并持续至第 24 个月。整个研究中治疗满意度均较高（≥84%）。
长期索利那新治疗具有良好的耐受性，并与 OAB 症状和 HRQL 的持续改善相关。
