Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.
Division of Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Neurourol Urodyn. 2021 Aug;40(6):1559-1568. doi: 10.1002/nau.24706. Epub 2021 May 26.
This study describes patients with different degrees and combinations of symptom resolution in response to fesoterodine exposure to aid physicians in counselling patients with overactive bladder (OAB) on the likelihood of treatment success.
Data came from 12-week fixed-dose studies of fesoterodine. The proportions of patients experiencing symptom resolution and change in patient-reported outcome measures (PROM) at 4, 8, and 12 weeks were calculated. Treatment-emergent adverse events (TEAE) were reported according to response in urinary urgency episodes (UUE). The relationship between PROM and response was examined.
Out of 6689 patients, 81.6% female, urgency urinary incontinence (UUI) episodes/24 h were more responsive to fesoterodine than UUE; with roughly 50% of patients reporting a 50% reduction and fewer than 10% reporting absence of UUE at 12 weeks compared to approximately 40%-50% reporting absence of UUI. TEAE was numerically lower in patients with greater response. There was a statistically significant relationship between improvement in urinary urgency and associated change in OAB-q symptom bother scores, r = 0.54, p < 0.001. At Week 4, 64.0%-76.7% of patients who had achieved a significant change in Patient Perception of Bladder Condition (PPBC) had a 50% reduction in UUI. At Week 12 this proportion was between 80% and 87.9%, with those being exposed to fesoterodine treatment reporting response in PPBC at numerically higher rates.
These data provide clinicians with information from which they may usefully communicate the likelihood of symptom resolution in response to pharmacotherapy for OAB and answer a key clinical question posed by many care providers. Roughly ⅓ of fesoterodine treated patients reported a 50% reduction urgency and ¾ reported 50% resolution of incontinence at 12 weeks. Total resolution of all symptoms was seldom achieved.
本研究描述了不同程度和组合的症状缓解患者对索利那新暴露的反应，以帮助医生向膀胱过度活动症（OAB）患者提供治疗成功的可能性。
数据来自索利那新的 12 周固定剂量研究。计算了 4、8 和 12 周时出现症状缓解和患者报告的结局测量（PROM）变化的患者比例。根据急迫性尿失禁事件（UUE）的反应报告治疗后出现的不良事件（TEAE）。检查了 PROM 与反应之间的关系。
在 6689 例患者中，81.6%为女性，急迫性尿失禁（UUI）发作/24 小时对索利那新的反应优于 UUE；约 50%的患者报告 UUE 减少 50%，而不到 10%的患者报告 12 周时 UUE 消失，而约 40%-50%的患者报告 UUI 消失。TEAE 在反应较大的患者中数量较低。在尿急迫性改善与 OAB-q 症状困扰评分相关变化之间存在统计学显著关系，r=0.54，p<0.001。在第 4 周，64.0%-76.7%的患者在患者对膀胱状况的感知（PPBC）方面有显著变化，其 UUI 减少 50%。在第 12 周，这一比例在 80%至 87.9%之间，接受索利那新治疗的患者在 PPBC 方面报告的反应比例更高。
这些数据为临床医生提供了信息，他们可以从中有用地传达对 OAB 药物治疗的症状缓解的可能性，并回答许多护理提供者提出的关键临床问题。大约 1/3 的索利那新治疗患者报告在 12 周时急迫性减少 50%，7/8 报告尿失禁减少 50%。很少有患者完全缓解所有症状。
