NorthShore University HealthSystem, University of Chicago, Pritzker School of Medicine, Chicago, IL, USA.
Drugs Aging. 2012 Feb 1;29(2):119-31. doi: 10.2165/11597970-000000000-00000.
Previous work has demonstrated the efficacy and safety of fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term fesoterodine treatment in different age groups has not been assessed.
The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with fesoterodine 8 mg in subjects with OAB syndrome.
This was a pooled analysis of two identically designed open-label extensions of 12-week, randomized, double-blind, placebo-controlled studies. The setting was urology and general practice offices. Subjects who participated in the 12-week, double-blind studies and opted to continue long-term, open-label treatment with fesoterodine were included. Subjects were initiated on fesoterodine 8 mg/day at open-label baseline. After 1 month, subjects could elect dose reduction to 4 mg/day and subsequent re-escalation to 8 mg; each was permitted once annually. Maximal duration of open-label treatment ranged from 24 to 36 months. Discontinuations, subject-reported treatment tolerance, and efficacy (3-day diaries) were assessed at open-label baseline and months 1, 4, 8, 12 and 24.
A total of 890 subjects were treated (age <45 years, n = 140; 45-64 years, n = 444; 65-74 years, n = 208; ≥75 years, n = 98); 49% continued treatment for ≥ 24 months (age <45 years, 43%; 45-64 years, 54%; 65-74 years, 50%; ≥75 years, 37%). Seventy-seven percent of subjects remained on fesoterodine 8 mg throughout treatment; this rate was highest among subjects aged ≥75 years (age <45 years, 72%; 45-64 years, 77%; 65-74 years, 73%; ≥75 years, 87%). Approximately 80% of continuing subjects were receiving fesoterodine 8 mg at each visit after open-label baseline up to 36 months. No new or unexpected safety signals were observed in any age group. Most subjects reported 'good' or 'excellent' treatment tolerance throughout the study (age <45 years, ≥90%; 45-64 years, ≥93%; 65-74 years, ≥85%; ≥75 years, ≥86%). Dry mouth, the most commonly reported treatment-emergent adverse event, was lowest among subjects aged ≥75 years (age <45 years, 31%; 45-64 years, 30%; 65-74 years, 32%; ≥75 years, 26%). Rates of discontinuation due to dry mouth were low in all age groups. Significant improvements in all diary variables, including urgency urinary incontinence episodes per 24 hours, micturitions per 24 hours, urgency episodes per 24 hours, and mean voided volume per micturition, observed between double-blind baseline and open-label baseline were sustained or increased during open-label treatment in the overall population and all age groups.
Long-term fesoterodine (administered primarily as 8 mg) was well tolerated and associated with sustained improvements in OAB symptoms, irrespective of age.
先前的研究已经证实了索利那新在伴有膀胱过度活动症（OAB）症状的老年和年轻患者中的疗效和安全性。但尚未评估不同年龄组长期使用索利那新的效果。
旨在确定年龄对 OAB 综合征患者长期使用索利那新 8mg 的安全性、耐受性和疗效的影响。
这是两项为期 12 周、随机、双盲、安慰剂对照研究的开放性扩展的汇总分析。研究场所为泌尿科和普通科诊所。参与了 12 周、双盲研究并选择继续长期接受索利那新开放性治疗的患者被纳入研究。患者在开放性研究基线时开始接受索利那新 8mg/天治疗。1 个月后，患者可以选择减少剂量至 4mg/天，然后再增加至 8mg/天；每年各允许一次。开放性治疗的最长持续时间从 24 个月到 36 个月不等。在开放性研究基线和第 1、4、8、12 和 24 个月时评估停药、患者报告的治疗耐受性和疗效（3 天日记）。
共有 890 名患者接受了治疗（年龄<45 岁，n=140；45-64 岁，n=444；65-74 岁，n=208；≥75 岁，n=98）；49%的患者继续治疗≥24 个月（年龄<45 岁，43%；45-64 岁，54%；65-74 岁，50%；≥75 岁，37%）。77%的患者在整个治疗过程中一直使用索利那新 8mg；≥75 岁的患者这一比例最高（年龄<45 岁，72%；45-64 岁，77%；65-74 岁，73%；≥75 岁，87%）。大约 80%的持续治疗患者在开放性研究基线后的每次就诊时都接受了索利那新 8mg 的治疗，直至 36 个月。在任何年龄组均未观察到新的或意外的安全性信号。大多数患者在整个研究过程中报告了“良好”或“极好”的治疗耐受性（年龄<45 岁，≥90%；45-64 岁，≥93%；65-74 岁，≥85%；≥75 岁，≥86%）。最常见的治疗后出现的不良事件口干，在≥75 岁的患者中发生率最低（年龄<45 岁，31%；45-64 岁，30%；65-74 岁，32%；≥75 岁，26%）。所有年龄组因口干而停药的发生率均较低。在总体人群和所有年龄组中，与双盲研究基线相比，在开放性研究基线时观察到的所有日记变量（包括 24 小时内急迫性尿失禁发作次数、24 小时内排尿次数、24 小时内急迫性发作次数以及每次排尿的平均尿量）均有显著改善，并在开放性治疗期间得到维持或增加。
长期使用索利那新（主要以 8mg 剂量给药）耐受性良好，与 OAB 症状的持续改善相关，与年龄无关。
