University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.
Urology. 2010 Dec;76(6):1350-7. doi: 10.1016/j.urology.2010.03.097. Epub 2010 Oct 25.
To assess the effect of age on fesoterodine efficacy and tolerability in subjects with an overactive bladder.
The data from 2 randomized, 12-week studies of 1681 subjects treated with fesoterodine 4 or 8 mg or placebo were pooled and stratified by age. The subjects completed 3-day bladder diaries at baseline and weeks 2 and 12, the King's Health Questionnaire at baseline and week 12, and the Treatment Benefit Scale at week 12.
Of the subjects aged <65 years, fesoterodine 4 and 8 mg was associated with statistically significant improvements in the diary variables at week 12 versus placebo. Greater improvement in urgency urinary incontinence was seen with fesoterodine 8 mg versus 4 mg. For those aged ≥65 to <75 years, fesoterodine 4 and 8 mg significantly improved all diary variables, except for the mean voided volume and micturition frequency, respectively, [corrected] versus placebo. In subjects aged ≥75 years, fesoterodine 8 mg significantly improved all diary variables, except for mean voided volume, versus placebo. No significant improvements were observed with fesoterodine 4 mg versus placebo. Fesoterodine significantly improved several King's Health Questionnaire domains versus placebo in all age groups. Fesoterodine 4 mg did not significantly improve any domains in subjects aged ≥75 years. In all age groups, the treatment response rates were significantly greater with both fesoterodine doses versus placebo. Dry mouth and constipation occurred more frequently in subjects aged ≥75 years receiving fesoterodine 8 mg than in those receiving fesoterodine 4 mg or placebo, although the discontinuation rates because of dry mouth and constipation were not increased.
Fesoterodine 4 and 8 mg effectively treated overactive bladder symptoms in subjects aged <75 years. Fesoterodine 8 mg was effective in subjects aged ≥75 years.
评估年龄对膀胱过度活动症患者福多司坦疗效和耐受性的影响。
对接受福多司坦 4 或 8mg 或安慰剂治疗的 1681 例患者的 2 项随机、12 周研究数据进行了汇总，并按年龄分层。患者在基线时和第 2、12 周完成 3 天膀胱日记，在基线和第 12 周完成 King's 健康问卷，在第 12 周完成治疗受益量表。
在年龄<65 岁的患者中，与安慰剂相比，福多司坦 4 和 8mg 在第 12 周时与日记变量相关的统计学显著改善。与福多司坦 4mg 相比，福多司坦 8mg 对急迫性尿失禁的改善更为明显。对于年龄 65 至<75 岁的患者，福多司坦 4 和 8mg 分别显著改善了除平均排尿量和排尿频率以外的所有日记变量[纠正]与安慰剂相比。在年龄≥75 岁的患者中，与安慰剂相比，福多司坦 8mg 显著改善了除平均排尿量以外的所有日记变量。与安慰剂相比，福多司坦 4mg 未观察到显著改善。在所有年龄组中，福多司坦均显著改善了几个 King's 健康问卷领域，与安慰剂相比。在年龄≥75 岁的患者中，福多司坦 4mg 未显著改善任何领域。在所有年龄组中，与安慰剂相比，福多司坦 4mg 显著改善了所有年龄组的治疗反应率。与接受福多司坦 4mg 或安慰剂的患者相比，年龄≥75 岁的患者服用福多司坦 8mg 时口干和便秘的发生率更高，尽管因口干和便秘而停药的比例并未增加。
福多司坦 4 和 8mg 可有效治疗年龄<75 岁的膀胱过度活动症患者的症状。福多司坦 8mg 对年龄≥75 岁的患者有效。
