Tegaserod is effective in the initial and retreatment of irritable bowel syndrome with constipation.

Abstract

BACKGROUND:

Symptoms of irritable bowel syndrome are often cyclical and thus may require repeated rather than continuous therapy. Tegaserod is effective and well-tolerated for irritable bowel syndrome with constipation but data on retreatment are lacking.

AIM:

To assess whether tegaserod retreatment is as efficacious and well-tolerated as initial treatment in a primary care setting.

METHODS:

This open-label trial was designed to evaluate the effectiveness of tegaserod under real-life conditions. Irritable bowel syndrome with constipation patients received tegaserod 6 mg b.d. for 12 weeks; response was assessed at weeks 4 and 12. Responders (those achieving satisfactory relief for at least 2 of the previous 4 weeks) at weeks 4 and/or 12 entered an 8-week withdrawal period where symptom recurrence was assessed. Patients experiencing recurrence could receive tegaserod 6 mg b.d. for another 4 weeks (retreatment phase) and on completion, could choose to continue tegaserod in a 6-month extension study.

RESULTS:

A total of 513 patients received initial treatment with tegaserod; 85.0% (436 of 513) responded. 403 responders entered the withdrawal period; symptoms recurred in 83.9% (338 of 403) after a mean of 38 days. Of the 307 patients who subsequently entered retreatment 89.3% (274 of 307) responded. Among patients entering the retreatment period, 269 (87.6%) had responded within the first 4 weeks of initial treatment. Of these, 243 (90.3%) responded to tegaserod retreatment. Adverse events were infrequent and similar during 4 weeks of the initial treatment period (11.1%) and on retreatment (10.4%). The extension study, completed by 188 of 232 (81.0%) patients, demonstrated good long-term tolerability of tegaserod.

CONCLUSIONS:

Irritable bowel syndrome with constipation patients can be successfully treated, and retreated, with tegaserod 6 mg b.d. Tegaserod was well-tolerated during initial and retreatment periods.

• Authors: S Müller-Lissner, G Holtmann, P Rueegg, G Weidinger, H Löffler
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 21 Issue 1 Pg. 11-20 (Jan 01 2005) ISSN: 0269-2813 [Print] England
• PMID: 15644040 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Gastrointestinal Agents
• Indoles
• tegaserod

Topics

• Adolescent
• Adult
• Constipation (drug therapy)
• Female
• Gastrointestinal Agents (therapeutic use)
• Humans
• Indoles (therapeutic use)
• Irritable Bowel Syndrome (drug therapy)
• Male
• Middle Aged
• Recurrence
• Retreatment
• Retrospective Studies
• Treatment Outcome