Department of Urology, Nihon University, Japan.
Medical Affairs, Astellas Pharma Inc., Japan.
Int J Urol. 2022 Jan;29(1):7-15. doi: 10.1111/iju.14700. Epub 2021 Oct 4.
To confirm if mirabegron 50 mg shows efficacy in women with overactive bladder and either urgency urinary incontinence or mixed urinary incontinence versus placebo.
Post-hoc analyses were carried out using pooled data from a Japanese phase IIb and a phase III study. The primary efficacy end-point was baseline to end-of-treatment change in the mean number of micturitions/24 h. The secondary end-points were changes in the mean voided volume/micturition, mean number of urgency and incontinence episodes/24 h, and mean number of nocturia episodes/night. Other end-points were quality of life and incontinence normalization rates.
Women with urgency urinary incontinence (placebo n = 204, mirabegron n = 214) and mixed urinary incontinence (placebo n = 122, mirabegron n = 139) were included. Change in mean micturitions/24 h at end-of-treatment for mirabegron was statistically significant versus placebo in both populations; the effect size increased over time. For all secondary end-points, median changes for mirabegron were statistically significant versus placebo at end-of-treatment, except for nocturia for the urgency urinary incontinence population and urgency for the mixed urinary incontinence population. Mirabegron showed larger improvements versus placebo in all quality-of-life domains, except for general health perception in the urgency urinary incontinence population. Incontinence normalization rates for mirabegron were 47.2% and 49.6% in the urgency urinary incontinence and mixed urinary incontinence populations, respectively, versus 42.6% and 39.3% for placebo.
Mirabegron 50 mg significantly improved key overactive bladder symptoms versus placebo in women with urgency urinary incontinence, and it also improved most overactive bladder symptoms, including micturition frequency, in patients with mixed urinary incontinence. These findings support the benefits of using mirabegron in the female overactive bladder wet population.
确认米拉贝隆 50mg 对伴有急迫性尿失禁或混合性尿失禁的膀胱过度活动症女性的疗效是否优于安慰剂。
对一项日本 IIb 期和 III 期研究的汇总数据进行了事后分析。主要疗效终点为治疗基线至结束时平均 24 小时排尿次数的变化。次要终点为每次排尿量/排尿次数、急迫性和失禁发作次数/24 小时以及夜间排尿次数/夜间的变化，以及生活质量和失禁正常化率。
纳入了急迫性尿失禁（安慰剂 n=204，米拉贝隆 n=214）和混合性尿失禁（安慰剂 n=122，米拉贝隆 n=139）的女性。治疗结束时，米拉贝隆组的平均排尿次数较安慰剂组有统计学意义，且这种效果随时间增加而增强。除了急迫性尿失禁人群的夜间排尿次数和混合性尿失禁人群的急迫性外，米拉贝隆组的所有次要终点在治疗结束时的中位数变化均与安慰剂组相比有统计学意义。米拉贝隆组在除了急迫性尿失禁人群的一般健康感知外的所有生活质量领域均优于安慰剂组。米拉贝隆的失禁正常化率分别为急迫性尿失禁和混合性尿失禁人群的 47.2%和 49.6%，安慰剂组分别为 42.6%和 39.3%。
米拉贝隆 50mg 可显著改善急迫性尿失禁女性的膀胱过度活动症的关键症状，且还可改善包括排尿频率在内的大多数膀胱过度活动症症状，在混合性尿失禁患者中。这些发现支持在女性膀胱过度活动症湿型人群中使用米拉贝隆的益处。
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