Abstract | AIM: To investigate the efficacy and safety of tegaserod, a novel 5-HT(4) receptor partial agonist, in a randomized, double-blind, placebo-controlled, 12-week treatment, multicentre study. METHODS: RESULTS:
Tegaserod, 2 mg b.d. and 6 mg b.d., showed a statistically significant relief of overall irritable bowel syndrome symptoms, measured by a weekly, self-administered questionnaire. At end-point, treatment differences from placebo were 12.7% and 11.8% for 2 mg b.d. and 6 mg b.d., respectively. The effect of tegaserod was noted as early as week 1, and was sustained over the 12-week treatment period. Individual irritable bowel syndrome symptoms assessed daily also showed a statistically significant improvement of abdominal discomfort/ pain, number of bowel movements and stool consistency, and a favourable trend for reducing days with significant bloating. Adverse events were similar in all groups, with transient diarrhoea being the only adverse event seen more frequently with tegaserod than placebo. CONCLUSIONS:
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Authors | S A Müller-Lissner, I Fumagalli, K D Bardhan, F Pace, E Pecher, B Nault, P Rüegg |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 15
Issue 10
Pg. 1655-66
(Oct 2001)
ISSN: 0269-2813 [Print] England |
PMID | 11564007
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Indoles
- Receptors, Serotonin
- Serotonin Receptor Agonists
- Receptors, Serotonin, 5-HT4
- tegaserod
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Topics |
- Abdominal Pain
(drug therapy, physiopathology)
- Adult
- Colonic Diseases, Functional
(drug therapy, physiopathology)
- Constipation
(drug therapy, physiopathology)
- Dose-Response Relationship, Drug
- Female
- Humans
- Indoles
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Receptors, Serotonin
- Receptors, Serotonin, 5-HT4
- Serotonin Receptor Agonists
(administration & dosage, therapeutic use)
- Surveys and Questionnaires
- Treatment Outcome
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