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Neurogastroenterology
A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation
  1. J Tack1,
  2. S Müller-Lissner2,
  3. P Bytzer3,
  4. R Corinaldesi4,
  5. L Chang5,
  6. A Viegas6,
  7. S Schnekenbuehl7,
  8. C Dunger-Baldauf7,
  9. P Rueegg7
  1. 1Department of Gastroenterology, Centre for Gastroenterological Research, University of Leuven, Leuven, Belgium
  2. 2Park-Klinik Weissensee, Humboldt University, Berlin, Germany
  3. 3Glostrup University Hospital, Copenhagen University, Copenhagen, Denmark
  4. 4Dipartimento di Medicina Interna e Gastroenterologia, Università degli Studi di Bologna, Bologna, Italy
  5. 5Center for Neurovisceral Sciences and Womens Health at UCLA, and VAGLAHS, Los Angeles, CA, USA
  6. 6Novartis Pharmaceuticals Corp, East Hanover, NJ, USA
  7. 7Novartis Pharma AG, Basel, Switzerland
  1. Correspondence to:
    Dr J Tack
    Department of Internal Medicine, Division of Gastroenterology, University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium; Jan.Tackmed.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.

  • CHMP, Committee for Medicinal Products for Human Use
  • IBS-C, irritable bowel syndrome with constipation
  • QoL, quality of life
  • TFI, treatment free interval
  • tegaserod
  • efficacy
  • safety
  • IBS-C women
  • repeated treatment

https://doi.org/10.1136/gut.2005.070789

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    Footnotes

    • Published online first 19 August 2005

    • The study was sponsored by Novartis Pharma AG.

    • Conflicts of interest: J Tack has no specific disclosures; he is listed in the Novartis Zelnorm Speakers’ Bureau. S Müller-Lissner is and was involved in drug trials and acts as an advisor for several pharmaceutical companies including Novartis. He is also listed in the Novartis Zelnorm Speakers’ Bureau. P Bytzer has no conflicts of interest to declare. R Corinaldesi has no conflicts of interest to declare. L Chang has received grant support from Novartis and is listed in the Novartis Zelnorm Speakers’ Bureau. A Viegas is a Novartis employee. S Schnekenbuehl is a Novartis employee. C Dunger-Baldauf is a Novartis employee. P Rueegg is a Novartis employee

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