Abstract | BACKGROUND: METHODS: Patients received either 1 mg of alosetron hydrochloride (n = 309) or placebo (n = 317) twice daily for 12 weeks, followed by a 4-week posttreatment period. Adequate relief of IBS pain and discomfort was the primary end point. Secondary end points included improvements in urgency, stool frequency, stool consistency, incomplete evacuation, and bloating. RESULTS: Seventy-one percent of patients were classified as having diarrhea-predominant IBS. Forty-three percent of alosetron-treated patients with diarrhea-predominant IBS reported adequate relief for all 3 months compared with 26% of placebo-treated patients (P<.001; percentage point difference = 17; 95% confidence interval, 8.0-25.4). Improvement with alosetron compared with placebo was observed by the end of the fourth week of treatment and persisted throughout the remainder of treatment. Alosetron significantly decreased urgency and stool frequency and caused firmer stools within 1 week of starting treatment. Effects were sustained throughout treatment and symptoms returned following treatment cessation. No significant improvement in the percentage of days with sense of incomplete evacuation or bloating was observed compared with placebo during the first month of treatment. Constipation was the most commonly reported adverse event. CONCLUSION:
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Authors | M Camilleri, W Y Chey, E A Mayer, A R Northcutt, A Heath, G E Dukes, D McSorley, A M Mangel |
Journal | Archives of internal medicine
(Arch Intern Med)
Vol. 161
Issue 14
Pg. 1733-40
(Jul 23 2001)
ISSN: 0003-9926 [Print] United States |
PMID | 11485506
(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
- Gastrointestinal Agents
- Serotonin Antagonists
- alosetron
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Topics |
- Administration, Oral
- Adult
- Aged
- Carbolines
(administration & dosage, therapeutic use)
- Colonic Diseases, Functional
(complications, drug therapy)
- Diarrhea
(drug therapy, etiology)
- Drug Administration Schedule
- Female
- Gastrointestinal Agents
(administration & dosage, therapeutic use)
- Humans
- Middle Aged
- Serotonin Antagonists
(administration & dosage, therapeutic use)
- Treatment Outcome
- United States
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