Quigley Eamonn M M, Wald Arnold, Fidelholtz James, Boivin Michel, Pecher Eckhard, Earnest David
Alimentary Pharmabiotic Centre, Department of Medicine, Cork University Hospital, Wilton, Cork, Ireland.
Clin Gastroenterol Hepatol. 2006 May;4(5):605-13. doi: 10.1016/j.cgh.2006.02.017.
BACKGROUND & AIMS: Studies show that tegaserod effectively relieves the symptoms of chronic constipation/idiopathic constipation (CC). This pooled analysis assessed the safety and tolerability of tegaserod in a large dataset of CC patients.
Adverse event (AE) data were pooled from 2 double-blind, placebo-controlled phase III trials of 12 weeks' duration. Post hoc analysis was conducted for the most frequent AEs (incidence, >or=3%).
Eight hundred eighty-one, 861, and 861 patients received tegaserod 6 mg twice a day, 2 mg twice a day, or placebo, respectively. Most AEs were mild/moderately severe. AE incidence was similar for the tegaserod 6 mg and 2 mg twice a day (57.1% and 56.3%, respectively) and placebo groups (59.6%) and most frequent in the gastrointestinal system (tegaserod 6 mg twice a day, 25.8%; 2 mg twice a day, 22.5%; placebo, 24.6%). Headache, the most common AE, was slightly more frequent in the placebo group (tegaserod 6 mg twice a day, 11.0%; 2 mg twice a day, 10.1%; placebo, 13.2%). Diarrhea (generally transient and resolved with continued treatment) was the only AE with a statistically significant difference between groups (tegaserod 6 mg twice a day 6.6% vs placebo 3.0%, P=.0005). Serious AE incidence (1.4% overall) was comparable across treatment groups, although abdominal surgery was less common in the combined tegaserod (0.5%) than the placebo group (1.0%). Discontinuation as a result of AEs was slightly higher in tegaserod 6 mg twice a day patients (5.7%; 2 mg twice a day, 3.3%; placebo, 3.7%), mainly because of diarrhea. Laboratory and electrocardiogram parameters were comparable across groups.
Tegaserod is well tolerated by patients with CC during 12 weeks of treatment.
研究表明替加色罗可有效缓解慢性便秘/特发性便秘（CC）的症状。本汇总分析评估了替加色罗在大量CC患者数据集中的安全性和耐受性。
不良事件（AE）数据来自2项为期12周的双盲、安慰剂对照III期试验。对最常见的不良事件（发生率≥3%）进行事后分析。
分别有881例、861例和861例患者接受每日2次6 mg替加色罗、每日2次2 mg替加色罗或安慰剂治疗。大多数不良事件为轻度/中度严重。每日2次6 mg替加色罗组和每日2次2 mg替加色罗组的不良事件发生率相似（分别为57.1%和56.3%），与安慰剂组（59.6%）相似，且在胃肠道系统中最为常见（每日2次6 mg替加色罗组为25.8%；每日2次2 mg替加色罗组为22.5%；安慰剂组为24.6%）。头痛是最常见的不良事件，在安慰剂组中略更常见（每日2次6 mg替加色罗组为11.0%；每日2次2 mg替加色罗组为10.1%；安慰剂组为13.2%）。腹泻（一般为短暂性，继续治疗可缓解）是唯一在组间存在统计学显著差异的不良事件（每日2次6 mg替加色罗组为6.6%，安慰剂组为3.0%，P = 0.0005）。严重不良事件发生率（总体为1.4%）在各治疗组间相当，尽管联合替加色罗组中腹部手术的发生率（0.5%）低于安慰剂组（1.0%）。因不良事件停药的情况在每日2次6 mg替加色罗组患者中略高（5.7%；每日2次2 mg替加色罗组为3.3%；安慰剂组为3.7%），主要原因是腹泻。各治疗组间的实验室和心电图参数相当。
CC患者在12周治疗期间对替加色罗耐受性良好。
