Sussman David, Garely Alan
Department of Surgery, University of Medicine and Dentistry of New Jersey, Stratford 08084, USA.
Curr Med Res Opin. 2002;18(4):177-84. doi: 10.1185/030079902125000570.
Treatment with the antimuscarinic agents tolterodine and oxybutynin is the mainstay of therapy for overactive bladder, a chronic and debilitating condition characterized by urinary urgency with or without urge incontinence, usually in combination with urinary frequency and nocturia. This study consisted of two trials; in one, patients with overactive bladder were randomized to 8 weeks of open-label treatment with either 2 mg or 4 mg of once-daily extended-release tolterodine (TER), and in the other to 5 mg or 10 mg of extended-release oxybutynin (OER). The study protocol and design were identical for the two trials and site selection ensured that there was no bias in either trial for the tendency of investigators to prescribe one drug rather than the other, or for geographical location. A total of 1289 patients were enrolled, 669 in the tolterodine trial (TER 2 mg, n = 333; TER 4 mg, n = 336) and 620 in the oxybutynin trial (OER 5 mg, n = 313; OER 10 mg, n = 307). Fewer patients prematurely withdrew from the trial in the TER 4 mg group (12%) than either the OER 5 mg (19%; p = 0.01) or OER 10 mg groups (21%; p = 0.002). More patients in the OER 10 mg group than the TER 4 mg group withdrew because of poor tolerability (13% vs 6%; p = 0.001). After 8 weeks, 70% of patients in the TER 4 mg group perceived an improved bladder condition, compared with 60% in the TER 2 mg group, 59% in the OER 5 mg group and 60% in the OER 10 mg group (all p < 0.01 vs TER 4 mg). Response to therapy was greater in a subgroup of patients whose perception of bladder condition was moderate to severe at baseline (TER 4 mg 77% vs OER 10 mg 65%; p < 0.01). Dry mouth was dose-dependent with both agents, although differences between doses only reached statistical significance in the oxybutynin trial (OER 5 mg vs OER 10 mg; p = 0.05). Patients treated with TER 4 mg reported a significantly lower severity of dry mouth compared with OER 10 mg. In conclusion, the greater efficacy and tolerability of tolterodine ER 4 mg suggests improved clinical effectiveness compared with oxybutynin ER 10 mg.
使用抗毒蕈碱药物托特罗定和奥昔布宁进行治疗是治疗膀胱过度活动症的主要方法，膀胱过度活动症是一种慢性且使人衰弱的病症，其特征为尿急，伴有或不伴有急迫性尿失禁，通常还伴有尿频和夜尿症。本研究包括两项试验；在一项试验中，膀胱过度活动症患者被随机分配接受为期8周的开放标签治疗，每日一次服用2毫克或4毫克的缓释托特罗定（TER），在另一项试验中，患者被随机分配接受5毫克或10毫克的缓释奥昔布宁（OER）。两项试验的研究方案和设计相同，并且通过地点选择确保在任何一项试验中，调查人员在开一种药物而非另一种药物的倾向或地理位置方面不存在偏差。总共招募了1289名患者，托特罗定试验中有669名（TER 2毫克组，n = 333；TER 4毫克组，n = 336），奥昔布宁试验中有620名（OER 5毫克组，n = 313；OER 10毫克组，n = 307）。TER 4毫克组中过早退出试验的患者（12%）少于OER 5毫克组（19%；p = 0.01）或OER 10毫克组（21%；p = 0.002）。由于耐受性差，OER 10毫克组中退出的患者比TER 4毫克组更多（13%对6%；p = 0.001）。8周后，TER 4毫克组中70%的患者感觉膀胱状况有所改善，而TER 2毫克组为60%，OER
