Gacci Mauro, Novara Giacomo, De Nunzio Cosimo, Tubaro Andrea, Schiavina Riccardo, Brunocilla Eugenio, Sebastianelli Arcangelo, Salvi Matteo, Oelke Matthias, Gravas Stavros, Carini Marco, Serni Sergio
Department of Urology, University of Florence, Careggi Hospital, Viale S, Luca - 50134, Florence, Italy.
BMC Urol. 2014 Oct 27;14:84. doi: 10.1186/1471-2490-14-84.
Overactive bladder (OAB)/ storage lower urinary tract symptoms (LUTS) have a high prevalence affecting up to 90% of men over 80 years. The role of sufficient therapies appears crucial. In the present review, we analyzed the mechanism of action of tolterodine extended-release (ER) with the aim to clarify its efficacy and safety profile, as compared to other active treatments of OAB/storage LUTS.
A wide Medline search was performed including the combination of following words: "LUTS", "BPH", "OAB", "antimuscarinic", "tolterodine", "tolterodine ER". IPSS, IPSS storage sub-score and IPSS QoL (International Prostate Symptom Score) were the validated efficacy outcomes. In addition, the numbers of urgency episodes/24 h, urgency incontinence episodes/24 h, incontinence episodes/24 h and pad use were considered. We also evaluated the most common adverse events (AEs) reported for tolterodine ER.
Of 128 retrieved articles, 109 were excluded. The efficacy and tolerability of tolterodine ER Vs. tolterodine IR have been evaluated in a multicenter, double-blind, randomized placebo controlled study in 1529 patients with OAB. A 71% mean reduction in urgency incontinence episodes was found in the tolterodine ER group compared to a 60% reduction in the tolterodine IR (p < 0.05). Few studies evaluated the clinical efficacy of α-blocker/tolterodine combination therapy. In patients with large prostates (prostate volume >29 cc) only the combination therapy significantly reduced 24-h voiding frequency (2.8 vs. 1.7 with tamsulosin, 1.4 with tolterodine, or 1.6 with placebo). A recent meta-analysis evaluating tolterodine in comparison with other antimuscarinic drugs demonstrated that tolterodine ER was significantly more effective than placebo in reducing micturition/24 h, urinary leakage episodes/24 h, urgency episodes/24 h, and urgency incontinence episodes/24 h. With regard to adverse events, tolterodine ER was associated with a good adverse event profile resulting in the third most favorable antimuscarinic. Antimuscarinic drugs are the mainstay of pharmacological therapy for OAB / storage LUTS; several studies have demonstrated that tolterodine ER is an effective and well tolerated formulation of this class of treatment.
Tolterodine ER resulted effective in reducing frequency urgency and nocturia and urinary leakage in male patients with OAB/storage LUTS. Dry mouth and constipation are the most frequently reported adverse events.
膀胱过度活动症（OAB）/储尿期下尿路症状（LUTS）的患病率很高，80岁以上男性中高达90%受其影响。充分治疗的作用似乎至关重要。在本综述中，我们分析了托特罗定缓释剂（ER）的作用机制，旨在阐明其与其他OAB/储尿期LUTS活性治疗方法相比的疗效和安全性。
进行了广泛的医学文献检索，包括以下关键词的组合：“LUTS”、“BPH”、“OAB”、“抗毒蕈碱药”、“托特罗定”、“托特罗定ER”。国际前列腺症状评分（IPSS）、IPSS储尿期子评分和IPSS生活质量评分是经过验证的疗效指标。此外，还考虑了24小时内尿急发作次数、急迫性尿失禁发作次数、尿失禁发作次数和护垫使用情况。我们还评估了托特罗定ER报告的最常见不良事件（AE）。
在检索到的128篇文章中，排除了109篇。在一项针对1529例OAB患者的多中心、双盲、随机安慰剂对照研究中，评估了托特罗定ER与托特罗定即释剂（IR）的疗效和耐受性。托特罗定ER组的急迫性尿失禁发作次数平均减少71%，而托特罗定IR组减少60%（p<0.05）。很少有研究评估α受体阻滞剂/托特罗定联合治疗的临床疗效。在前列腺体积较大（前列腺体积>29立方厘米）的患者中，只有联合治疗能显著降低24小时排尿频率（坦索罗辛组为2.8次，托特罗定组为1.7次，安慰剂组为1.4次，联合治疗组为1.6次）。最近一项比较托特罗定与其他抗毒蕈碱药物的荟萃分析表明，托特罗定ER在减少24小时排尿次数、尿失禁发作次数、尿急发作次数和急迫性尿失禁发作次数方面显著优于安慰剂。关于不良事件，托特罗定ER的不良事件谱良好，是第三大最有利的抗毒蕈碱药物。抗毒蕈碱药物是OAB/储尿期LUTS药物治疗的主要手段；多项研究表明，托特罗定ER是这类治疗中一种有效且耐受性良好的制剂。
托特罗定ER在减少OAB/储尿期LUTS男性患者的尿频、尿急、夜尿和尿失禁方面有效。口干和便秘是最常报告的不良事件。
