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

¹ Department of Gastroenterology, Centre for Gastroenterological Research, University of Leuven, Leuven, Belgium
² Park-Klinik Weissensee, Humboldt University, Berlin, Germany
³ Glostrup University Hospital, Copenhagen University, Copenhagen, Denmark
⁴ Dipartimento di Medicina Interna e Gastroenterologia, Università degli Studi di Bologna, Bologna, Italy
⁵ Center for Neurovisceral Sciences and Womens Health at UCLA, and VAGLAHS, Los Angeles, CA, USA
⁶ Novartis Pharmaceuticals Corp, East Hanover, NJ, USA
⁷ Novartis Pharma AG, Basel, Switzerland

Correspondence to:
Correspondence to:
Dr J Tack
Department of Internal Medicine, Division of Gastroenterology, University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium; Jan.Tack{at}med.kuleuven.ac.be

ABSTRACT
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<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.

Abbreviations: CHMP, Committee for Medicinal Products for Human Use; IBS-C, irritable bowel syndrome with constipation; QoL, quality of life; TFI, treatment free interval

Keywords: tegaserod; efficacy; safety; IBS-C women; repeated treatment

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