Sa. Muller-lissner et al., Tegaserod, a 5-HT4 receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation, ALIM PHARM, 15(10), 2001, pp. 1655-1666
Aim: To investigate the efficacy and safety of tegaserod, a novel 5-HT4 rec
eptor partial agonist, in a randomized, double-blind, placebo-controlled, 1
2-week treatment, multicentre study.
Methods: Eight hundred and eighty-one patients with irritable bowel syndrom
e, characterized by abdominal pain, bloating and constipation, received teg
aserod, 2 mg b.d. or 6 mg b.d., or placebo for 12 weeks.
Results: Tegaserod, 2 mg b.d. and 6 mg b.d., showed a statistically signifi
cant relief of overall irritable bowel syndrome symptoms, measured by a wee
kly, self-administered questionnaire. At end-point, treatment differences f
rom 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 ov
er the 12-week treatment period. Individual irritable bowel syndrome sympto
ms assessed daily also showed a statistically significant improvement of ab
dominal discomfort/pain, number of bowel movements and stool consistency, a
nd 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: Based upon the results of this study, tegaserod offers rapid a
nd sustained relief of the abdominal pain and constipation associated with
irritable bowel syndrome. Tegaserod is also well tolerated.