Improvement in pain and bowel function in female irritable bowel patients with alosetron, a 5-HT3 receptor antagonist

Authors


Camilleri Mayo Clinic, GI Research Unit - Alfred 2-435, 200 First Street S.W., Rochester, MN 55905. E-mail: camilleri.michael@mayo.edu

Abstract

Background

: No currently available treatment provides consistent relief of irritable bowel syndrome. Colonic sensory and motor function are modulated partly through 5HT3-receptors.

Aim

: To evaluate effects of the 5HT3-receptor antagonist, alosetron, in irritable bowel syndrome.

Methods

: Randomized, double-blind, placebo-controlled, dose-ranging (1, 2, 4, 8 mg b.d. alosetron), 12-week trial in 370 patients with diarrhoea-predominant or alternating constipation and diarrhoea irritable bowel syndrome. Weekly measurement of adequate relief was the key end-point; other irritable bowel syndrome symptoms were collected daily using an electronic phone system.

Results

: Alosetron (1 mg or 2 mg b.d.) significantly (< 0.05 vs. placebo) increased the proportion of females, but not males, reporting adequate relief. Stool consistency, frequency and percentage days with urgency improved over placebo (< 0.05) within the first month with all doses of alosetron, and persisted throughout the trial with all doses in female patients. With 1 mg b.d. alosetron, females had improved stool consistency and urgency within the first week, and adequate relief and improved stool frequency within the first 2 weeks. There was no consistent improvement in bowel function among male patients.

Conclusion

: In female irritable bowel syndrome patients with predominant diarrhoea or alternating constipation and diarrhoea, alosetron is effective in treatment of abdominal pain and discomfort and bowel-related symptoms.

Ancillary