Yoshida Masaki, Ikeda Makoto, Nawata Shigeki, Nagai Shinji, Kubono Shinichi, Uno Takashi, Maeda Shotaro
Department of Urology, Sakurajyuji Hospital, Kumamoto, JPN.
Medical Affairs, Kyorin Pharmaceutical Co. Ltd., Tokyo, JPN.
Cureus. 2024 Oct 8;16(10):e71106. doi: 10.7759/cureus.71106. eCollection 2024 Oct.
Objective To compare the efficacy of vibegron for urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) in patients with overactive bladder (OAB). Methods We performed a post hoc analysis of a phase 3 study of vibegron in Japanese patients with OAB. Based on the patterns recorded in the three-day bladder diary, only female patients were categorized into UUI and MUI populations. The primary endpoint was the change in the mean micturition number per 24 hours from baseline to week 12. Other endpoints included the mean changes in urgency episodes per 24 hours, incontinence episodes per 24 hours, voided volume per micturition, and the number of nocturia episodes per night. The proportion of urinary incontinence (UI) normalization, quality of life (QOL) as measured by the King's Health Questionnaire (KHQ), and patient satisfaction level as assessed by the Patient Global Impression (PGI) were investigated. Result Data from a UUI population (vibegron 50 mg, n = 237; vibegron 100 mg, n = 231; placebo, n = 237) and an MUI population (vibegron 50 mg, n = 70; vibegron 100 mg, n = 77; placebo, n = 78) were analyzed. Vibegron 50 mg and 100 mg significantly improved the change in micturition number per 24 hours from baseline to week 12. Compared to those of patients receiving a placebo, all other endpoints of urinary parameters were significantly improved in patients receiving vibegron, except for nocturia in the vibegron 50 mg group in both populations. In the vibegron 50 mg, vibegron 100 mg, and placebo groups, the proportions of those who attained normalization of UI were stratified by the UUI (51.5%, 57.6%, and 44.7%, respectively) and MUI (40.0%, 41.6%, and 20.5%, respectively) populations. Furthermore, both vibegron doses improved KHQ scores in both populations, and PGI improvement was significantly higher than that in the placebo group in both populations. Conclusion This post hoc analysis demonstrated that vibegron has equivalent efficacy and safety in the MUI and UUI populations. The results of this study provide important information for the treatment of MUI.
目的 比较维贝格隆治疗膀胱过度活动症（OAB）患者急迫性尿失禁（UUI）和混合性尿失禁（MUI）的疗效。方法 我们对维贝格隆在日本OAB患者中进行的3期研究进行了事后分析。根据三天膀胱日记记录的模式，仅将女性患者分为UUI和MUI人群。主要终点是从基线到第12周每24小时平均排尿次数的变化。其他终点包括每24小时尿急发作次数、每24小时尿失禁发作次数、每次排尿的尿量以及每晚夜尿次数的平均变化。研究了尿失禁（UI）恢复正常的比例、通过国王健康问卷（KHQ）测量的生活质量（QOL）以及通过患者整体印象（PGI）评估的患者满意度水平。结果 分析了UUI人群（维贝格隆50 mg，n = 237；维贝格隆100 mg，n = 231；安慰剂，n = 237）和MUI人群（维贝格隆50 mg，n = 70；维贝格隆100 mg，n = 77；安慰剂，n = 78）的数据。维贝格隆50 mg和100 mg显著改善了从基线到第12周每24小时排尿次数的变化。与接受安慰剂的患者相比，接受维贝格隆的患者除了两个群体中维贝格隆50 mg组的夜尿外，所有其他尿液参数终点均有显著改善。在维贝格隆50 mg、维贝格隆100 mg和安慰剂组中，UI恢复正常的比例按UUI人群（分别为51.5%、57.6%和44.7%）和MUI人群（分别为40.0%、41.6%和20.5%）分层。此外，两种维贝格隆剂量均改善了两个群体的KHQ评分，并且两个群体中PGI的改善均显著高于安慰剂组。结论 这项事后分析表明，维贝格隆在MUI和UUI人群中具有同等的疗效和安全性。本研究结果为MUI的治疗提供了重要信息。
