An Asia-Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome

• Published in: Gut Vol. 52; no. 5; pp. 671 - 676
• Main Authors: Kellow, J, Lee, O Y, Chang, F Y, Thongsawat, S, Mazlam, M Z, Yuen, H, Gwee, K A, Bak, Y T, Jones, J, Wagner, A
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and British Society of Gastroenterology 01.05.2003; BMJ Publishing Group Ltd; BMJ Publishing Group LTD; Copyright 2003 by Gut
• Subjects: 5-HT4; 5-hydroxytryptamine (type 4) receptor; Abdomen; Adult; adverse event; Asia-Pacific; Clinical trials; Colonic Diseases, Functional - complications; Colonic Diseases, Functional - drug therapy; Colonic Diseases, Functional - physiopathology; Constipation; Diarrhea; Diarrhea - drug therapy; Diarrhea - etiology; Diarrhea - physiopathology; double blind study; Double-Blind Method; Drug dosages; Drug therapy; Female; Gastrointestinal Agents - adverse effects; Gastrointestinal Agents - therapeutic use; Humans; IBS; Indoles - adverse effects; Indoles - therapeutic use; intention to treat; Irritable Bowel Syndrome; ITT; Laxatives; Male; Middle Aged; Motility; NNT; number needed to treat; Pain; Pharmaceutical industry; Product information; SAE; serious adverse event; Studies; tegaserod; Treatment Outcome; Switzerland
• ISSN: 0017-5749; 1468-3288; 1458-3288
• DOI: 10.1136/gut.52.5.671

Background: Tegaserod has been shown to be an effective therapy for the multiple symptoms of irritable bowel syndrome (IBS) in Western populations. However, little information is available regarding the use of tegaserod in the Asia-Pacific population. Aims: To evaluate the efficacy, safety, and tolerability of tegaserod versus placebo in patients with IBS from the Asia-Pacific region. Patients: A total of 520 patients from the Asia-Pacific region with IBS, excluding those with diarrhoea predominant IBS. Methods: Patients were randomised to receive either tegaserod 6 mg twice daily (n=259) or placebo (n=261) for a 12 week treatment period. The primary efficacy variable (over weeks 1–4) was the response to the question: “Over the past week do you consider that you have had satisfactory relief from your IBS symptoms?” Secondary efficacy variables assessed overall satisfactory relief over 12 weeks and individual symptoms of IBS. Results: The mean proportion of patients with overall satisfactory relief was greater in the tegaserod group than in the placebo group over weeks 1–4 (56% v 35%, respectively; p<0.0001) and weeks 1–12 (62% v 44%, respectively; p<0.0001). A clinically relevant effect was observed as early as week 1 and was maintained throughout the treatment period. Reductions in the number of days with at least moderate abdominal pain/discomfort, bloating, no bowel movements, and hard/lumpy stools were greater in the tegaserod group compared with the placebo group. Headache was the most commonly reported adverse event (12.0% tegaserod v 11.1% placebo). Diarrhoea led to discontinuation in 2.3% of tegaserod patients. Serious adverse events were infrequent (1.5% tegaserod v 3.4% placebo). Conclusions: Tegaserod 6 mg twice daily is an effective, safe, and well tolerated treatment for patients in the Asia-Pacific region suffering from IBS and whose main bowel symptom is not diarrhoea.