St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02135, USA.
Neurourol Urodyn. 2011 Nov;30(8):1480-5. doi: 10.1002/nau.21099. Epub 2011 May 10.
To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study.
Subjects were randomized to fesoterodine 4 mg or placebo. At week 2, subjects could remain on 4 mg (non-escalators) or choose to increase to 8 mg (escalators) for the remaining 10 weeks (sham escalation for placebo). Subjects completed 3-day bladder diaries at baseline, week 2 and week 12 noting micturitions, urgency episodes, and urgency urinary incontinence (UUI) episodes.
Sixty-three per cent of 438 subjects randomized to fesoterodine and 73% of 445 randomized to placebo dose escalated. At baseline, fesoterodine escalators had significantly more micturitions and urgency episodes than fesoterodine non-escalators (P < 0.001); at week 2, before dose escalation, diary-dry rate and improvement in micturitions and urgency episodes were significantly greater among fesoterodine non-escalators versus escalators (P < 0.001); and by week 12, after dose escalation, diary-dry rate and improvements in micturitions and UUI episodes were similar between fesoterodine non-escalators and escalators (P > 0.05). The placebo escalator group did not demonstrate a similar response over placebo non-escalators following the dose escalation decision point.
A rapid and robust response to fesoterodine 4 mg was demonstrated in non-escalators. Subjects who chose to dose escalate to fesoterodine 8 mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8 mg fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4-mg dose.
在一项灵活剂量研究中，描述选择或不选择剂量递增的患者对索利那新治疗膀胱过度活动症（OAB）的反应特征。
将受试者随机分配至索利那新 4 毫克或安慰剂组。在第 2 周，受试者可以继续服用 4 毫克（非递增组）或选择增加至 8 毫克（递增组），共 10 周（安慰剂组为假递增）。受试者在基线、第 2 周和第 12 周完成 3 天膀胱日记，记录排尿次数、尿急发作和急迫性尿失禁（UUI）发作次数。
438 名随机分配至索利那新的受试者中有 63%和 445 名随机分配至安慰剂的受试者中有 73%进行了剂量递增。基线时，与索利那新非递增组相比，索利那新递增组的排尿次数和尿急发作明显更多（P<0.001）；在第 2 周，剂量递增前，与递增组相比，非递增组的日记干率和排尿次数及尿急发作的改善更为显著（P<0.001）；在第 12 周，剂量递增后，非递增组和递增组的日记干率和排尿次数及 UUI 发作的改善相似（P>0.05）。在剂量递增决策点后，安慰剂递增组与安慰剂非递增组相比，并未表现出对安慰剂的类似反应。
在非递增组中，索利那新 4 毫克的快速和显著疗效得到了证实。在第 2 周选择剂量递增至索利那新 8 毫克的患者与基线和第 2 周（递增前）相比，以及与安慰剂相比，在第 12 周显示出显著改善。增加至 8 毫克索利那新剂量为患者提供了与对 4 毫克剂量满意的患者相似的疗效和耐受性。
