Tufts University School of Medicine, Boston, Massachusetts.
Seattle Urology Research Center, Seattle, Washington.
J Urol. 2021 May;205(5):1421-1429. doi: 10.1097/JU.0000000000001574. Epub 2020 Dec 28.
The long-term safety, tolerability and efficacy of vibegron in adults with overactive bladder were evaluated in the 40-week phase 3 EMPOWUR extension study.
Patients who completed 12 weeks of once-daily vibegron 75 mg or tolterodine 4 mg extended release in EMPOWUR continued double-blind treatment; patients who completed 12 weeks of placebo were randomly assigned 1:1 to receive double-blind vibegron or tolterodine. The primary outcome was safety, measured by incidence of adverse events. Secondary outcomes included change from baseline at week 52 in average daily number of micturitions and urgency episodes (all patients), and urge and total urinary incontinence episodes (patients with overactive bladder wet) based on 7-day diary data.
Of 506 patients randomized 505 received ≥1 dose of medication, and 430 (85%) completed the study. A total of 12 patients (2.4%) discontinued owing to adverse events. The most common adverse events with vibegron/tolterodine (>5% in either group) were hypertension (8.8%/8.6%), urinary tract infection (6.6%/7.3%), headache (5.5%/3.9%), nasopharyngitis (4.8%/5.2%) and dry mouth (1.8%/5.2%). Improvements in efficacy end points were maintained for patients receiving vibegron for 52 weeks; least squares mean change from baseline to week 52 in micturitions was ‒2.4 for vibegron vs ‒2.0 for tolterodine; in urge urinary incontinence episodes ‒2.2 vs ‒1.7 (p <0.05); in urgency episodes ‒3.4 vs ‒3.2; and in total incontinence episodes ‒2.5 vs ‒1.9 (p <0.05). Among patients with overactive bladder wet 61.0% receiving vibegron experienced ≥75% reduction in urge urinary incontinence episodes after 52 weeks of treatment vs 54.4% with tolterodine, while 40.8% vs 34.2% experienced a 100% reduction.
Vibegron demonstrated favorable long-term safety, tolerability and efficacy in patients with overactive bladder, consistent with results of the 12-week study.
评估维贝格隆在患有膀胱过度活动症的成年人中的长期安全性、耐受性和疗效，研究为为期 40 周的 3 期 EMPOWUR 扩展研究。
完成每日一次维贝格隆 75mg 或托特罗定 4mg 延长释放期 12 周的患者继续接受双盲治疗；完成 12 周安慰剂治疗的患者以 1:1 的比例随机分配接受双盲维贝格隆或托特罗定治疗。主要结局是安全性，通过不良反应发生率来衡量。次要结局包括根据 7 天日记数据，52 周时平均每日排尿次数和急迫发作次数（所有患者）以及急迫和总尿失禁发作次数（有膀胱过度活动症的患者）的变化。
506 名随机患者中有 505 名患者接受了至少 1 剂药物治疗，430 名（85%）完成了研究。共有 12 名患者（2.4%）因不良反应而停药。维贝格隆/托特罗定最常见的不良反应（两组发生率均超过 5%）为高血压（8.8%/8.6%）、尿路感染（6.6%/7.3%）、头痛（5.5%/3.9%）、鼻咽炎（4.8%/5.2%）和口干（1.8%/5.2%）。接受维贝格隆治疗 52 周的患者的疗效终点改善情况保持稳定；与托特罗定相比，维贝格隆组自基线至 52 周时的排尿次数最小平方均数变化为减少 2.4，急迫性尿失禁次数减少 2.2；急迫发作次数减少 3.4；总失禁次数减少 2.5（均为 p<0.05）。在有膀胱过度活动症的湿尿患者中，61.0%接受维贝格隆治疗的患者在 52 周治疗后至少有 75%的急迫性尿失禁发作减少，而接受托特罗定治疗的患者为 54.4%，而 40.8%接受维贝格隆治疗的患者减少 100%，而接受托特罗定治疗的患者为 34.2%。
维贝格隆在患有膀胱过度活动症的患者中表现出良好的长期安全性、耐受性和疗效，与 12 周研究结果一致。
