Efficacy of Fesoterodine on Nocturia and Quality of Sleep in Asian Patients With Overactive Bladder
Efficacy of Fesoterodine on Nocturia and Quality of Sleep in Asian Patients With Overactive Bladder
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DOI：
10.1016/j.urology.2013.12.008
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发表时间：
2014-04-01
期刊：
影响因子：
2.1
通讯作者：
Yamagami, Hidetomi
中科院分区：
文献类型：
--
作者：
Yokoyama, Osamu;Hiro, Shintaro;Yamagami, Hidetomi
目的探讨非索罗定与安慰剂对膀胱过度活动症和排尿困难患者排尿困难、睡眠障碍和睡眠质量的疗效。在报告排尿次数≥ 8次和≥ 10次的亚洲成人中进行的非索罗定4和8 mg/天的安慰剂对照试验基线时每24小时1次尿急性尿失禁发作。报告>= 1次夜间排尿/24 h的患者纳入本分析。疗效变量包括从基线至第12周/治疗结束的夜间排尿/24 h、夜间排尿量/排尿和无干扰睡眠小时数的变化。睡眠相关的生活质量进行了评估，使用国王的健康问卷睡眠/能源领域。结果：在555例患者中，非索罗定4 mg组（-0.63）和8 mg组（-0.77）的夜间排尿减少在数值上大于安慰剂组（-0.56），但差异不显著（P > 0.05）。当排除夜间多尿指数>33%的患者时，非索罗定8 mg组夜间排尿减少显著大于安慰剂组（-0.24; P = .031）。非索罗定4 mg组（38.07 mL; P = 0.013）和8 mg组（42.05 mL; P
OBJECTIVE To investigate the efficacy of fesoterodine vs placebo on nocturia, sleep disturbance, and sleeprelated quality of life (QoL) in patients with overactive bladder and nocturia.METHODS This posthoc analysis used data from a 12-week, randomized, placebo-controlled trial of fesoterodine 4 and 8 mg per day in Asian adults reporting >= 8 micturitions and >= 1 urgency urinary incontinence episodes per 24 hours at baseline. Patients who reported >= 1 nocturnal micturition/24 h were included in this analysis. Efficacy variables included change from baseline to week 12/end of treatment in nocturnal micturitions/24 h, nocturnal voided volume/micturition, and hours of undisturbed sleep. Sleep-related QoL was assessed using King's Health Questionnaire Sleep/Energy domain. Treatment comparisons were made using analysis of covariance.RESULTS Among 555 patients, reductions in nocturnal micturitions with fesoterodine 4 mg (-0.63) and 8 mg (-0.77) were numerically greater vs placebo (-0.56), but differences were not significant (P >.05). When patients with a nocturnal polyuria index >33% were excluded, the decrease in nocturnal micturitions was significantly greater with fesoterodine 8 mg vs placebo (-0.24; P = .031). Increases in nocturnal voided volume/micturition were significantly greater with fesoterodine 4 (38.07 mL; P = .013) and 8 mg (42.05 mL; P