Park C, Park J, Choo M-S, Kim J C, Lee J G, Lee J Z, Lee K-S, Kim D Y, Lee S-J, Seo J T
Department of Urology, Gangneung Asan Medical Center, University of Ulsan College of Medicine, Gangneung, Korea.
Int J Clin Pract. 2014 Feb;68(2):188-96. doi: 10.1111/ijcp.12255. Epub 2013 Dec 22.
To assess the efficacy and safety of imidafenacin compared with propiverine for treatment of overactive bladder (OAB) in Korean patients.
Patients with OAB symptoms were randomised to double-blind treatment with 0.1 mg of imidafenacin twice daily (group A) or propiverine 20 mg once daily (group B) for 12-week regimen, and assessed for efficacy and safety. The primary efficacy outcome was per cent change of weekly urgency urinary incontinence (UUI) episodes at week 12. The secondary efficacy outcomes were changes in the micturitions per day, urine volume voided per micturition, urgency episodes per day, complete disappearance of incontinence episodes and severity of urgency from baseline to week 12. Quality of life and safety profiles were also compared.
Of 162 patients randomised, 140 completed the study protocol. The per cent change of weekly UUI episodes at week 12 was -69.1% in group A and -70.4% in group B (both p < 0.0001). The lower limit of 95% one-sided confidence interval of the difference between the groups was above the non-inferiority margin (-19.42%). Other voiding parameters and quality of life significantly improved at week 12 in both the groups. The discontinuation rates caused by adverse events were low in both the groups. While dry mouth was the most common adverse event (group A: 28.4% vs. B: 30.4%, p = 0.783), the severity of dry mouth was significantly less in the group A than B (p = 0.042) There were no significant differences in other safety profiles.
After the 12-week treatment of imidafenacin 0.1 mg twice daily, all OAB symptoms and quality of life improved. Imidafenacin was not inferior to propiverine for the reduction of UUI episodes, and was better tolerated than propiverine in the safety profile. Our results indicate that imidafenacin is a safe and effective drug in Korean patients with OAB.
评估在韩国患者中，与丙哌维林相比，咪达那新治疗膀胱过度活动症（OAB）的疗效和安全性。
有OAB症状的患者被随机分为两组，进行为期12周的双盲治疗，A组每日两次服用0.1毫克咪达那新，B组每日一次服用20毫克丙哌维林，并对疗效和安全性进行评估。主要疗效指标是第12周时每周急迫性尿失禁（UUI）发作次数的变化百分比。次要疗效指标包括从基线到第12周每天排尿次数、每次排尿尿量、每天急迫发作次数、失禁发作完全消失情况以及急迫严重程度的变化。还比较了生活质量和安全性。
162例随机分组的患者中，140例完成了研究方案。第12周时，A组每周UUI发作次数的变化百分比为-69.1%，B组为-70.4%（两组p均<0.0001）。两组之间差异的95%单侧置信区间下限高于非劣效界值（-19.42%）。两组在第12周时其他排尿参数和生活质量均有显著改善。两组因不良事件导致的停药率均较低。口干是最常见的不良事件（A组：28.4% vs. B组：30.4%，p = 0.783），但A组口干的严重程度明显低于B组（p = 0.042）。其他安全性方面无显著差异。
每日两次服用0.1毫克咪达那新进行12周治疗后，所有OAB症状和生活质量均得到改善。在减少UUI发作次数方面，咪达那新不劣于丙哌维林，且在安全性方面耐受性优于丙哌维林。我们的结果表明，咪达那新对韩国OAB患者是一种安全有效的药物。
