膀功能和Vibegron的安全性在治疗良性前列腺增生症的过活膀的男性中:来自第三期随机对照的CORAGE试验的结果
Eric S Rovner1, Janet Owens-Grillo2, Elizabeth Thomas2
1Medical University of South Carolina, Charleston, South Carolina, USA.
Neurourology and urodynamics
|December 9, 2025
概括
维贝格龙在患有良性前列腺增生症 (BPH) 的男性中改善了过活性膀 (OAB) 症状,但没有增加尿的风险. 泌尿动力学数据证实,与膀功能相关的安全问题没有出现.
科学领域:
- 泌尿器科 泌尿器科 泌尿器科 泌尿器科
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 患有过度活动膀 (OAB) 的男性往往同时患有良性前列腺增生症 (BPH).
- 对BPH的药物治疗可能无法完全解决OAB症状.
- 评估BPH男性OAB的额外治疗方法至关重要.
研究的目的:
- 评估vibegron在患有OAB和BPH同时接受BPH药疗的男性的疗效和安全性.
- 为了在这个人群中提供vibegron的额外安全性,膀功能和尿动力学数据.
- 在COURAGE试验 (NCT03902080) 中,比较vibegron与安慰剂.
主要方法:
- 这是一项为期24周,第三期,双盲,安慰剂控制的试验.
- 随机选择的男性 (≥45岁) 患有OAB和BPH,接受α-阻断剂±5α-减少酶抑制剂,接受vibegron或安慰剂.
- 收集后空余尿量 (PVR),最大尿流速 (Uroflow-Qmax),国际前列腺症状评分 (IPSS) 和不良事件 (AE).
- 泌尿动力学副研究评估了基线和第12周的Qmax和Qmax (PdetQmax) 的排泄器压力.
主要成果:
- 与安慰剂相比,Vibegron在PVR和Uroflow-Qmax中显示出极小的差异.
- 在第24周,Vibegron导致IPSS总得分 (-7.3) 与安慰剂 (-5.7) 相比,平均降低更大.
- 尿留不良事件在小组之间是低的和相似的 (0.9%vibegron与0.7%安慰剂).
- 泌尿动力学显示,vibegron对Qmax或PdetQmax没有显著的负面影响.
结论:
- 维贝格伦在改善BPH男性的OAB症状方面表现出有效性.
- 没有通过尿动力学识别出与膀功能相关的安全信号.
- 与安慰剂相比,使用vibegron时,尿或增加残留尿量的风险没有增加.
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