Tegaserod, a 5-HT(4) receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation.
OBJECTIVE
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
Eight hundred and eighty-one patients with irritable bowel syndrome, characterized by abdominal pain, bloating and constipation, received tegaserod, 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 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
Based upon the results of this study, tegaserod offers rapid and sustained relief of the abdominal pain and constipation associated with irritable bowel syndrome. Tegaserod is also well tolerated.
Müller-Lissner
S A
SA
Park-Klinik Weissensee, Berlin, Germany.
Fumagalli
I
I
Bardhan
K D
KD
Pace
F
F
Pecher
E
E
Nault
B
B
Rüegg
P
P
D015746:Abdominal Pain / Q000188:drug therapy / Q000503:physiopathology; D000328:Adult; D003109:Colonic Diseases, Functional / Q000188:drug therapy* / Q000503:physiopathology; D003248:Constipation / Q000188:drug therapy / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011985:Receptors, Serotonin; D044422:Receptors, Serotonin, 5-HT4; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D007211:Indoles; D011985:Receptors, Serotonin; D017366:Serotonin Receptor Agonists; D044422:Receptors, Serotonin, 5-HT4; C105050:tegaserod