Fock Kwong M, Wagner Amy
Changi General Hospital, Singapore, Singapore.
J Gastroenterol Hepatol. 2007 Aug;22(8):1190-8. doi: 10.1111/j.1440-1746.2007.04955.x. Epub 2007 May 24.
BACKGROUND AND AIM: The 5-HT(4) receptor agonist tegaserod (6 mg b.i.d.) provides significantly better overall multiple symptom relief compared with placebo in patients with irritable bowel syndrome with constipation (IBS-C). The clinical benefit and safety of tegaserod in IBS-C patients has been demonstrated worldwide in several studies. The aim of this study was to obtain further safety and tolerability data in patients with IBS in the Asia-Pacific region, and to assess patients' satisfaction and compliance with treatment and willingness to re-use tegaserod in a post-marketing setting. METHODS: A multicenter, single-arm, open-label trial was conducted at 869 outpatient centers in 10 countries. Men and women with IBS, whose predominant bowel symptom was not diarrhea (non-D-IBS), received tegaserod for 4-12 weeks. Safety and tolerability were assessed by recording adverse events (AE). Patients were questioned about compliance, satisfaction with treatment and willingness to use tegaserod in future. RESULTS: Data were available from 14 537 patients (18% men, 82% women). Four percent of patients reported at least one AE. The most common AE were diarrhea (2%) and abdominal pain (1%), and most treatment-related AE occurred in the first week of treatment. Serious AE (SAE) were observed in eight patients, and no deaths were reported. Most patients (79%) reported to be satisfied or very satisfied with treatment, and 76% stated they would use tegaserod in the future. Compliance was 97%. CONCLUSIONS: Tegaserod has a favorable safety and tolerability profile for treating non-D-IBS and IBS-C in men and women in the Asia-Pacific region. Satisfaction with tegaserod treatment can be expected in the majority of patients.
背景与目的:在便秘型肠易激综合征(IBS-C)患者中,5-羟色胺(5-HT)4受体激动剂替加色罗(6毫克,每日两次)相较于安慰剂,能显著更好地缓解多种症状。替加色罗在IBS-C患者中的临床疗效和安全性已在全球多项研究中得到证实。本研究的目的是获取亚太地区IBS患者更多的安全性和耐受性数据,并在上市后环境中评估患者对治疗的满意度、依从性以及再次使用替加色罗的意愿。 方法:在10个国家的869个门诊中心进行了一项多中心、单臂、开放标签试验。以非腹泻为主的肠易激综合征(非腹泻型IBS)患者,无论男女,接受替加色罗治疗4至12周。通过记录不良事件(AE)评估安全性和耐受性。询问患者关于依从性、对治疗的满意度以及未来使用替加色罗的意愿。 结果:共有14537例患者的数据可供分析(男性占18%,女性占82%)。4%的患者报告至少出现了一种不良事件。最常见的不良事件是腹泻(2%)和腹痛(1%),大多数与治疗相关的不良事件发生在治疗的第一周。8例患者出现严重不良事件(SAE),未报告死亡病例。大多数患者(79%)报告对治疗满意或非常满意,76%的患者表示他们未来会使用替加色罗。依从性为97%。 结论:替加色罗在亚太地区治疗男性和女性非腹泻型IBS和IBS-C时,具有良好的安全性和耐受性。大多数患者对替加色罗治疗有望感到满意。
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