Frankel Jeffrey, Staskin David, Varano Susann, Kennelly Michael J, Jankowich Rachael A, Haag-Molkenteller Cornelia
Seattle Urology Research Center, Seattle, WA, USA.
Tufts University School of Medicine, Boston, MA, USA.
Ther Clin Risk Manag. 2022 Mar 3;18:171-182. doi: 10.2147/TCRM.S310371. eCollection 2022.
Pharmacologic treatment for overactive bladder (OAB), which is characterized by bothersome symptoms such as urgency and urge urinary incontinence (UUI), includes anticholinergics and β-adrenergic receptor agonists. Anticholinergics are associated with adverse effects including dry mouth, constipation, cognitive impairment, and increased risk of dementia. Therefore, the drug class of β-adrenergic receptor agonists may represent an effective, safe treatment option. Vibegron, a β-adrenergic receptor agonist, was approved for use in Japan (2018) and the United States (2020). Over the past 3 years, 2 phase 3 trials (EMPOWUR, EMPOWUR extension) have been conducted with once-daily vibegron 75 mg for the treatment of OAB, and additional secondary and subgroup analyses have detailed the efficacy and safety of vibegron. In the international phase 3 EMPOWUR trial, treatment with vibegron was associated with significant improvements compared with placebo in efficacy outcomes of micturition frequency, UUI episodes, urgency episodes, and volume voided as early as week 2 that were sustained throughout the 12-week trial. The 40-week EMPOWUR extension study, following the 12-week treatment period, demonstrated sustained efficacy in patients receiving vibegron for 52 weeks. Treatment with vibegron was also associated with improvements in patient-reported measures of quality of life. Across studies, vibegron was generally safe and well tolerated. A separate, dedicated ambulatory blood pressure monitoring study showed that treatment with vibegron was not associated with clinically meaningful effects on blood pressure or heart rate. Across all studies, vibegron was efficacious, safe, and well tolerated and thus represents a valuable treatment option for patients with OAB. Here, nearly 1 year after US approval, we review the published data on efficacy and safety of vibegron 75 mg for the treatment of OAB.
膀胱过度活动症（OAB）的特征是出现尿急和急迫性尿失禁（UUI）等令人烦恼的症状，其药物治疗包括抗胆碱能药物和β-肾上腺素能受体激动剂。抗胆碱能药物会产生包括口干、便秘、认知障碍以及痴呆风险增加等不良反应。因此，β-肾上腺素能受体激动剂这类药物可能是一种有效、安全的治疗选择。维贝格隆是一种β-肾上腺素能受体激动剂，已在日本（2018年）和美国（2020年）获批使用。在过去3年中，已开展了2项3期试验（EMPOWUR、EMPOWUR扩展试验），使用每日一次75毫克的维贝格隆治疗OAB，另外的次要分析和亚组分析详细阐述了维贝格隆的疗效和安全性。在国际3期EMPOWUR试验中，与安慰剂相比，维贝格隆治疗在排尿频率、UUI发作次数、尿急发作次数和排尿量等疗效指标方面早在第2周就有显著改善，且在整个12周试验期间持续存在。在为期12周的治疗期之后进行的为期40周的EMPOWUR扩展研究表明，接受维贝格隆治疗52周的患者疗效持续。维贝格隆治疗还与患者报告的生活质量改善相关。在各项研究中，维贝格隆总体上安全且耐受性良好。一项单独的、专门的动态血压监测研究表明，维贝格隆治疗对血压或心率没有临床意义上的影响。在所有研究中，维贝格隆有效、安全且耐受性良好，因此是OAB患者的一种有价值的治疗选择。在此，在美国获批近1年后，我们回顾了已发表的关于75毫克维贝格隆治疗OAB的疗效和安全性的数据。
