Geriatric Medicine, Clinical Research Consulting, 2080 Bridgeport Avenue, Suite D, Milford, CT, 06460, USA.
Department of Surgery, Division of Urology, Tufts University School of Medicine, Boston, MA, USA.
Drugs Aging. 2021 Feb;38(2):137-146. doi: 10.1007/s40266-020-00829-z. Epub 2021 Jan 20.
Overactive bladder (OAB) is common among older adults. The efficacy and safety of vibegron for the treatment of OAB were demonstrated in the international, phase III EMPOWUR trial. This subpopulation analysis from EMPOWUR assessed the efficacy and safety of vibegron in patients aged ≥ 65 and ≥ 75 years.
In EMPOWUR, patients with OAB were randomly assigned 5:5:4 to receive once-daily vibegron 75 mg, placebo, or tolterodine 4 mg extended release, respectively, once daily for 12 weeks. Coprimary efficacy endpoints were change from baseline at week 12 in average daily number of micturitions and urge urinary incontinence (UUI) episodes; a key secondary efficacy endpoint was change from baseline at week 12 in average daily number of urgency episodes. Safety was assessed through adverse events (AEs). Efficacy analyses compared vibegron with placebo; no efficacy comparisons were made between vibegron and tolterodine.
Of the 1463 patients with evaluable efficacy data, 628 patients were aged ≥ 65 years, and 179 were aged ≥ 75 years. After 12 weeks, patients treated with once-daily vibegron 75 mg in both age subgroups showed significant improvements from baseline versus placebo in all three symptoms of OAB: daily micturitions (≥ 65 years, P < 0.0001; ≥75 years, P < 0.05), UUI episodes (≥ 65 years, P < 0.001; ≥ 75 years, P < 0.0001), and urgency episodes (≥ 65 years, P < 0.01; ≥ 75 years, P < 0.01). Significant reductions from baseline versus placebo in daily micturitions, UUI episodes, and urgency episodes were observed beginning at week 2 for patients aged ≥ 65 years treated with vibegron. In patients aged ≥ 65 years, 50.0% of those receiving vibegron versus 29.8% receiving placebo experienced a ≥ 75% reduction in UUI episodes at week 12 (P < 0.0001). Rates of cardiovascular-associated AEs were low for patients receiving vibegron (<2% of patients in either age subgroup) and similar to rates in patients receiving placebo. In patients aged ≥ 65 years, hypertension was reported by 1.2%, 3.1%, and 2.9% of patients receiving vibegron, placebo, and tolterodine, respectively; in patients aged ≥ 75 years, hypertension was reported by 1.3%, 3.3%, and 2.1%, respectively.
In this subpopulation analysis of patients with OAB aged ≥ 65 and ≥ 75 years from the EMPOWUR study, once-daily vibegron 75 mg showed rapid onset and robust efficacy versus placebo and was generally safe and well tolerated, consistent with results from the overall population.
ClinicalTrials.gov identifier NCT03492281; registered April 10, 2018.
膀胱过度活动症（OAB）在老年人中很常见。在国际三期 EMPOWUR 试验中，证明了维格列汀治疗 OAB 的疗效和安全性。本项来自 EMPOWUR 的亚组分析评估了维格列汀在 65 岁及以上和 75 岁及以上患者中的疗效和安全性。
在 EMPOWUR 中，OAB 患者随机分为 5:5:4 组，分别接受每日一次维格列汀 75mg、安慰剂或托特罗定 4mg 缓释剂治疗，疗程均为 12 周。主要疗效终点为治疗 12 周时与基线相比平均每日排尿次数和急迫性尿失禁（UUI）发作次数的变化；关键次要疗效终点为治疗 12 周时与基线相比平均每日急迫发作次数的变化。通过不良事件（AE）评估安全性。疗效分析比较了维格列汀与安慰剂的疗效；未对维格列汀与托特罗定的疗效进行比较。
在有可评估疗效数据的 1463 例患者中，628 例患者年龄≥65 岁，179 例患者年龄≥75 岁。治疗 12 周后，年龄均≥65 岁的患者每日接受一次维格列汀 75mg 治疗，与安慰剂相比，OAB 的所有三种症状均有显著改善：每日排尿次数（≥65 岁，P＜0.0001；≥75 岁，P＜0.05）、UUI 发作次数（≥65 岁，P＜0.001；≥75 岁，P＜0.0001）和急迫发作次数（≥65 岁，P＜0.01；≥75 岁，P＜0.01）。与安慰剂相比，年龄均≥65 岁的患者接受维格列汀治疗，每日排尿次数、UUI 发作次数和急迫发作次数从第 2 周开始均有显著减少。在年龄均≥65 岁的患者中，接受维格列汀治疗的患者中有 50.0%（安慰剂组为 29.8%）在第 12 周时 UUI 发作次数减少≥75%（P＜0.0001）。接受维格列汀治疗的患者心血管相关 AE 发生率较低（两个年龄亚组中均＜2%），与接受安慰剂的患者相似。年龄均≥65 岁的患者中，接受维格列汀、安慰剂和托特罗定治疗的患者高血压发生率分别为 1.2%、3.1%和 2.9%；年龄均≥75 岁的患者高血压发生率分别为 1.3%、3.3%和 2.1%。
在 EMPOWUR 研究中，年龄≥65 和≥75 岁的 OAB 患者的亚组分析中，每日一次维格列汀 75mg 与安慰剂相比，起效迅速，疗效显著，且通常安全且耐受良好，与总体人群的结果一致。
ClinicalTrials.gov 标识符 NCT03492281；于 2018 年 4 月 10 日注册。
