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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.
Gut 2005; 54(12):1707-13Gut

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 (> 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+Show Affiliations

Department of Gastroenterology, Centre for Gastroenterological Research, University of Leuven, Leuven, Belgium. Jan.Tack@med.kuleuven.ac.beNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16020489

Citation

Tack, J, et al. "A Randomised Controlled Trial Assessing the Efficacy and Safety of Repeated Tegaserod Therapy in Women With Irritable Bowel Syndrome With Constipation." Gut, vol. 54, no. 12, 2005, pp. 1707-13.
Tack J, Müller-Lissner S, Bytzer P, et al. A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Gut. 2005;54(12):1707-13.
Tack, J., Müller-Lissner, S., Bytzer, P., Corinaldesi, R., Chang, L., Viegas, A., ... Rueegg, P. (2005). A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Gut, 54(12), pp. 1707-13.
Tack J, et al. A Randomised Controlled Trial Assessing the Efficacy and Safety of Repeated Tegaserod Therapy in Women With Irritable Bowel Syndrome With Constipation. Gut. 2005;54(12):1707-13. PubMed PMID: 16020489.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. AU - Tack,J, AU - Müller-Lissner,S, AU - Bytzer,P, AU - Corinaldesi,R, AU - Chang,L, AU - Viegas,A, AU - Schnekenbuehl,S, AU - Dunger-Baldauf,C, AU - Rueegg,P, Y1 - 2005/07/14/ PY - 2005/7/16/pubmed PY - 2005/12/15/medline PY - 2005/7/16/entrez SP - 1707 EP - 13 JF - Gut JO - Gut VL - 54 IS - 12 N2 - 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. SN - 0017-5749 UR - https://www.unboundmedicine.com/medline/citation/16020489/A_randomised_controlled_trial_assessing_the_efficacy_and_safety_of_repeated_tegaserod_therapy_in_women_with_irritable_bowel_syndrome_with_constipation_ L2 - http://gut.bmj.com/cgi/pmidlookup?view=long&amp;pmid=16020489 DB - PRIME DP - Unbound Medicine ER -