根据4月14日举行的欧洲泌尿协会(EAU)年度会议上发布的一项研究，非索罗定与安慰剂相比，可为对托特罗定缓释药物(ER)响应不佳的膀胱过度活动症(OAB)及紧迫性尿失禁(UUI)患者提供显著的额外临床获益。

虽然非索罗定与托特罗定均为抗毒蕈碱药物，有共同活性部分，但它们在体内的代谢方式不同，这样就为患者在寻求最佳治疗的过程中提供了切换药物的机会。

两项头对头研究显示，非索罗定8mg在降低UUI发作方面优于托特罗定缓释药物4mg。

研究中受试者为18岁及以上患者，他们出现OAB症状有6个月或更长时间，在患者膀胱症状感知量表(PPBC)上至少属于“某些温和问题”。在为期3天的记录中，患者每24小时排尿≥8次，UUI发作2至15次。

在一个周期为2周的非盲试验中，患者以托特罗定缓释药物4mg治疗后，642名患者在一个双盲试验中被随机配给安慰剂或非索罗定4mg，治疗一周，然后以8mg治疗12周。

对于第一个主要终点，即在第12周时与基线值相比每24小时UUI平均发作次数，安慰剂组及非索罗定治疗组均有显著下降。对于次要终点，即第12周时每24小时UUI平均发作次数与基线值相比的变化，积极治疗明显提升了患者的收益。

所有试验组最常见不良事件是口干和便秘。有两例患者出现尿潴留，均在托特罗定缓释药物试验组。“如果你有一位患者接受托特罗定缓释药物治疗效果不是很好，那他们可以改变一下治疗方式，使用非索罗定可以获得效果，”Arums博士称。该临床研究的资金由辉瑞提供。

Fesoterodine Effective for Patients With Overactive Bladder Who Do Not Respond to Tolterodine: Presented at EAU

STOCKHOLM, Sweden -- April 17, 2014 -- Fesoterodine provides significant additional clinical benefit over placebo for patients with overactive bladder (OAB) and urgency urinary incontinence (UUI) who respond suboptimally to tolterodine extended release (ER), according to a study presented here on April 14 at the 29th Annual European Association of Urology (EAU) Congress.

Although fesoterodine and tolterodine are antimuscarinics have a common active moiety, they are differently processed in the body, and thus provide the opportunity for patients to switch agent in search of optimal treatment.

Two head-to-head studies showed that fesoterodine 8 mg is superior to tolterodine extended release (ER) 4 mg in reducing UUI episodes. Daniel Arums, MD, Medical Affairs, Pfizer Europe, Madrid, Spain, and colleagues assessed the characteristics of tolterodine ER responders and partial responders and the effect of fesoterodine in tolterodine partial responders.

Patients in the study were aged 18 years and older and had OAB symptoms for 6 months or more with at least “some moderate problems” on the Patient Perception of Bladder Condition (PPBC). Patients had ≥8 micturitions and 2 to 15 UUI episodes per 24 hours on a 3-day diary.

Patients were treated with tolterodine ER 4 mg during a 2-week, open-label run-in, after which 642 patients were randomised in a double-blind fashion to placebo (n = 320) or fesoterodine 4 mg for 1 week, followed by 8 mg for 12 weeks (n = 322).

For the first primary outcome of mean number of UUI episodes/24 hours from baseline to week 12, these were significantly reduced for both placebo (3.8 vs 2.1; P< .0001) and fesoterodine (3.9 vs 1.6; P< .0001).

For the second primary outcome of mean change of UUI episodes/24 hours from baseline to week 12 for placebo versus fesoterodine, the active treatment promoted significantly greater patient benefit (-1.9 vs -2.4; P = .0079).

Secondary outcomes for placebo versus fesoterodine were also generally in favour of active treatment, including the percentage of patients with >50% reduction in UUI episodes from baseline to week 12 (57.0% vs. 69.9%; P = .0027) and PPBC and Urgency Perception Scale scores (P< .0001, P = .0095, respectively).

The most common adverse events for all groups were dry mouth and constipation. Urinary retention was only seen for 2 patients, both in the tolterodine ER run-in arm.

“If you have a patient treated with tolterodine ER who is not doing well, they can achieve efficacy with a treatment change to fesoterodine,” said Dr. Arums.

Funding for this study was provided by Pfizer Inc.

[Presentation title: Responders and Partial Responders to Tolterodine Extended Release: Effect of Fesoterodine in Tolterodine Partial Responders. Abstract 585]

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