Chuang Yao-Chi, Lin Chih-Chieh, Chow Po-Ming, Lien Chi-Shun, Tsui Ke-Hung, Chou Chieh-Lung, Lee Hsiang-Ying, Meng En, Kuo Hann-Chorng
Department of Urology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Department of Urology, Taipei Veterans General Hospital and Department of Urology, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Low Urin Tract Symptoms. 2021 Jan;13(1):108-117. doi: 10.1111/luts.12341. Epub 2020 Aug 25.
This study evaluated the efficacy and safety of imidafenacin 0.1 mg twice daily vs placebo for Taiwanese patients with overactive bladder (OAB) after a 12-week oral administration.
This randomized, double-blind, placebo-controlled, two-arm, parallel-group, prospective study enrolled 118 patients across 11 study sites in Taiwan. Subjects were randomized to imidafenacin or placebo in a 2:1 ratio and entered the 12-week treatment period. At the subsequent visits, efficacy outcome measures and safety assessments were collected for analysis. The primary efficacy outcome was the change in the mean number of micturitions per day. Secondary endpoints included mean changes from baseline in urgency episodes and urge incontinence episodes per day and mean volume voided per micturition. Safety outcomes were also collected and compared between groups.
A total of 78 and 40 patients were allocated to the imidafenacin and placebo groups, respectively. Among them, 100 patients (imidafenacin, 65 and placebo, 35) completed the trial. Compared with placebo, imidafenacin was significantly better at reducing the number of micturitions per day (-1.29 ± 2.23 vs -0.46 ± 3.49, P = .0171) and reducing the mean number of urge incontinence episodes (-0.15 ± 0.52 vs 0.04 ± 0.50, P = .0386) at week 12. Adverse events were reported in 35 subjects (44.9%) and 16 (40%) in the imidafenacin and placebo groups, including constipation (n = 3, 4), dry mouth (n = 11, 2), and urinary tract infection (n = 7, 4), respectively. One patient in the imidafenacin group had mild dysuria.
Imidafenacin demonstrated efficacy and safety in the treatment of OAB in Taiwanese patients.
本研究评估了每日两次口服0.1毫克咪达那新与安慰剂相比，对台湾膀胱过度活动症（OAB）患者的疗效和安全性。
本随机、双盲、安慰剂对照、双臂、平行组、前瞻性研究在台湾的11个研究地点招募了118名患者。受试者以2:1的比例随机分配至咪达那新组或安慰剂组，并进入为期12周的治疗期。在随后的访视中，收集疗效指标和安全性评估数据进行分析。主要疗效指标是每日平均排尿次数的变化。次要终点包括每日尿急发作次数和急迫性尿失禁发作次数相对于基线的平均变化，以及每次排尿的平均尿量。还收集了安全性结果并在组间进行比较。
分别有78名和40名患者被分配至咪达那新组和安慰剂组。其中，100名患者（咪达那新组65名，安慰剂组35名）完成了试验。与安慰剂相比，在第12周时，咪达那新在减少每日排尿次数（-1.29±2.23对-0.46±3.49，P = 0.0171）和减少急迫性尿失禁发作的平均次数（-0.15±0.52对0.04±0.50，P = 0.0386）方面明显更好。咪达那新组和安慰剂组分别有35名（44.9%）和16名（40%）受试者报告了不良事件，包括便秘（分别为3例、4例）、口干（分别为11例、2例）和尿路感染（分别为7例、4例）。咪达那新组有1名患者出现轻度排尿困难。
咪达那新在治疗台湾OAB患者中显示出疗效和安全性。
