Abstract | BACKGROUND: METHODS: We studied 647 female IBS patients with diarrhoea-predominant or alternating bowel patterns (diarrhoea and constipation). 324 patients were assigned 1 mg alosetron and 323 placebo orally twice daily for 12 weeks, followed by a 4-week post-treatment period. Adequate relief of abdominal pain and discomfort was the primary endpoint; secondary endpoints included improvements in urgency, stool frequency, and stool consistency. Analysis was by intention to treat. FINDINGS: 79 (24%) of patients in the alosetron group and 53 (16%) in the placebo group dropped out. The difference in the drop-out rate between groups was mainly due to a greater occurrence of constipation in the alosetron group. A greater proportion of alosetron-treated patients than placebo-treated patients (133 [41%] vs 94 [29%], respectively) reported adequate relief for all 3 months of treatment (difference 12% [4.7-19.2]). Alosetron also significantly decreased urgency and stool frequency, and increased stool firmness. Constipation occurred in 30% and 3% of patients in the alosetron and placebo groups, respectively. INTERPRETATION:
Alosetron was well tolerated and clinically effective in alleviating pain and bowel-related symptoms in this population of women with IBS.
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Authors | M Camilleri, A R Northcutt, S Kong, G E Dukes, D McSorley, A W Mangel |
Journal | Lancet (London, England)
(Lancet)
Vol. 355
Issue 9209
Pg. 1035-40
(Mar 25 2000)
ISSN: 0140-6736 [Print] England |
PMID | 10744088
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Carbolines
- Receptors, Serotonin
- Receptors, Serotonin, 5-HT3
- Serotonin Antagonists
- alosetron
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Topics |
- Administration, Oral
- Adult
- Carbolines
(adverse effects, therapeutic use)
- Colonic Diseases, Functional
(diagnosis, drug therapy)
- Drug Administration Schedule
- Female
- Gastrointestinal Transit
(drug effects)
- Humans
- Middle Aged
- Receptors, Serotonin
(drug effects)
- Receptors, Serotonin, 5-HT3
- Serotonin Antagonists
(adverse effects, therapeutic use)
- Treatment Outcome
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