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 econo mic measures. Patients: Women (≥18 years of age) with IBS-C according to the R ome II criteria. Methods: Prospective, double blind, placebo controlled, randomi sed trial. Women with IBS-C either received tegaserod 6 mg twice daily or place bo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-rand omised to tegaserod or placebo for an additional month. Primary efficacy variabl es were response (overall IBS symptoms and abdominal discomfort/pain) to first a nd repeated treatment. Analysis was by intention to treat. Results: 2660 patient s and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy vari able (first treatment: 33.7%v 24.2%responders respectively for relief of IBS s ymptoms and 31.3%v 22.1%for relief of abdominal discomfort/ pain; repeated tre atment: 44.9%v 28.7%, and 42.4%v 27.1%, all p < 0.0001). Tegaserod was super ior to placebo for every secondary efficacy variable (relief of abdominal discom fort/pain, bloating and constipation; stool frequency and consistency). A respon se to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than plac ebo (p < 0.05). Conclusion: Tegaserod provides rapid and sustained relief of IBS -C symptoms both during first and repeated treatment.
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