Toglia Marc R, Ostergard Donald R, Appell Rodney A, Andoh Masakazu, Fakhoury Allam, Hussain Iqbal F
Urogynecology Associates of Philadelphia, Outpatient Pavilion, Suite 3404, 1098 West Baltimore Pike, Media, PA 19063, USA.
Int Urogynecol J. 2010 Jul;21(7):847-54. doi: 10.1007/s00192-010-1120-6. Epub 2010 Mar 26.
VENUS evaluated the efficacy of solifenacin on urgency in patients with overactive bladder (OAB). We hypothesized that solifenacin would be comparably efficacious in continent and incontinent patients.
VENUS was a 12-week, placebo-controlled trial in patients with OAB. Treatment efficacy was assessed using bladder diaries and patient-reported outcome measures. The primary endpoint was the change in daily urgency episodes. Exploratory subgroup analyses were conducted using baseline continence status.
Solifenacin reduced urgency episodes versus placebo in continent (-3.4 vs. -2.3) and incontinent patients (-4.2 vs. -2.9) and incontinence episodes (-2.1 vs. -1.2) in that subgroup; 58% versus 42% of incontinent patients receiving solifenacin versus placebo were continent at study end. In both cohorts, solifenacin- versus placebo-treated patients showed greater improvements in perceptions of urgency severity, symptom bother, and health-related quality of life.
This post hoc analysis demonstrates the efficacy of solifenacin regardless of baseline continence status.
VENUS研究评估了索利那新对膀胱过度活动症（OAB）患者尿急症状的疗效。我们假设索利那新在有控尿能力和尿失禁的患者中疗效相当。
VENUS是一项针对OAB患者的为期12周的安慰剂对照试验。使用膀胱日记和患者报告的结局指标评估治疗效果。主要终点是每日尿急发作次数的变化。使用基线控尿状态进行探索性亚组分析。
在该亚组中，与安慰剂相比，索利那新减少了有控尿能力患者的尿急发作次数（-3.4比-2.3）和尿失禁患者的尿急发作次数（-4.2比-2.9）以及尿失禁发作次数（-2.1比-1.2）；在研究结束时，接受索利那新治疗的尿失禁患者中有58%实现控尿，而接受安慰剂治疗的为42%。在两个队列中，与安慰剂治疗的患者相比，接受索利那新治疗的患者在尿急严重程度感知、症状困扰和健康相关生活质量方面有更大改善。
这项事后分析表明，无论基线控尿状态如何，索利那新均有疗效。
