A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation

• Published in: Gut 2005-12, Vol.54 (12), p.1707-1713
• Main Authors: Tack, J, Müller-Lissner, S, Bytzer, P, Corinaldesi, R, Chang, L, Viegas, A, Schnekenbuehl, S, Dunger-Baldauf, C, Rueegg, P
• Format: Article
• Language: English
• Subjects: Abdomen; Adolescent; Adult; Aged; Biological and medical sciences; CHMP; Clinical trials; Committee for Medicinal Products for Human Use; Constipation; Constipation - drug therapy; Constipation - rehabilitation; Double-Blind Method; Drug Administration Schedule; efficacy; Efficiency; Female; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal Agents - adverse effects; Gastrointestinal Agents - therapeutic use; Humans; IBS-C; IBS-C women; Indoles - adverse effects; Indoles - therapeutic use; Irritable bowel syndrome; Irritable Bowel Syndrome - drug therapy; Irritable Bowel Syndrome - rehabilitation; irritable bowel syndrome with constipation; Laxatives; Medical sciences; Middle Aged; Neurogastroenterology; Other diseases. Semiology; Pain; Patient Satisfaction; Prospective Studies; QoL; Quality of Life; repeated treatment; safety; Serotonin Receptor Agonists - adverse effects; Serotonin Receptor Agonists - therapeutic use; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; tegaserod; TFI; treatment free interval; Treatment Outcome
• ISSN: 0017-5749; 1468-3288; 1458-3288
• DOI: 10.1136/gut.2005.070789

Background: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. Aims: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. Patients: Women (⩾18 years of age) with IBS-C according to the Rome II criteria. Methods: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. Results: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p