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 (> or = 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 < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05). CONCLUSION:Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.
RCT Entities:
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 (> or = 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 < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05). CONCLUSION:Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.
Authors: S A Müller-Lissner; I Fumagalli; K D Bardhan; F Pace; E Pecher; B Nault; P Rüegg Journal: Aliment Pharmacol Ther Date: 2001-10 Impact factor: 8.171
Authors: E Corazziari; P Bytzer; M Delvaux; G Holtmann; J R Malagelada; J Morris; S Muller-Lissner; R C Spiller; J Tack; P J Whorwell Journal: Aliment Pharmacol Ther Date: 2003-09-15 Impact factor: 8.171
Authors: J Kellow; O Y Lee; F Y Chang; S Thongsawat; M Z Mazlam; H Yuen; K A Gwee; Y T Bak; J Jones; A Wagner Journal: Gut Date: 2003-05 Impact factor: 23.059
Authors: J Novick; P Miner; R Krause; K Glebas; H Bliesath; G Ligozio; P Rüegg; M Lefkowitz Journal: Aliment Pharmacol Ther Date: 2002-11 Impact factor: 8.171
Authors: P Paré; Ronald Bridges; Malcolm C Champion; Subhas C Ganguli; James R Gray; E Jan Irvine; Victor Plourde; Pierre Poitras; Geoffrey K Turnbull; Paul Moayyedi; Nigel Flook; Stephen M Collins Journal: Can J Gastroenterol Date: 2007-04 Impact factor: 3.522
Authors: Maria C F Passos; Anthony J Lembo; Lisa A Conboy; Ted J Kaptchuk; John M Kelly; Mary T Quilty; Catherine E Kerr; Eric E Jacobson; Rong Hu; Elizabeth Friedlander; Douglas A Drossman Journal: Am J Gastroenterol Date: 2009-03-17 Impact factor: 10.864