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Effect of tegaserod in chronic constipation: a randomized, double-blind, controlled trial
John F Johanson1, Arnold Wald, Gervais Tougas
1University of Illinois College of Medicine, Rockford, IL, USA.
Summary
Tegaserod significantly improved chronic constipation symptoms in a 12-week study. This serotonin receptor partial agonist was safe and well-tolerated, with no rebound effect observed after withdrawal.
Area of Science:
- Gastroenterology
- Pharmacology
Background:
- Chronic constipation is a prevalent gastrointestinal disorder.
- Serotonin subtype 4 receptor partial agonists represent a therapeutic avenue for constipation.
Purpose of the Study:
- To evaluate the efficacy, safety, and tolerability of tegaserod in patients with chronic constipation.
- To assess tegaserod's impact on bowel movement frequency and associated symptoms.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 1348 patients.
- Patients received tegaserod (2 mg or 6 mg twice daily) or placebo for 12 weeks.
- Responder status defined by increased complete spontaneous bowel movements (CSBMs) per week.
Main Results:
- Significantly higher CSBM responder rates with tegaserod (41.4%-43.2%) versus placebo (25.1%) during weeks 1-4 (P < 0.0001), maintained over 12 weeks.
- Tegaserod demonstrated statistically significant improvements in constipation symptoms compared to placebo.
- Adverse events like headache and nasopharyngitis were more frequent in the placebo group.
Conclusions:
- Tegaserod effectively improves chronic constipation symptoms over 12 weeks.
- Tegaserod is a safe and well-tolerated treatment option for chronic constipation.
- No rebound constipation effect was noted after treatment cessation.