A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation (IBS-C).

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 b.i.d. or placebo for 1 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: 2,660 patients and 1,191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% vs 24.2% responders respectively for relief of IBS symptoms and 31.3% vs 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% vs 28.7%, and 42.4% vs 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.