Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial
Autor: | David J. McSorley, Steven Kong, Northcutt Allison Ruth, Allen W. Mangel, George E. Dukes, Michael Camilleri |
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Rok vydání: | 2000 |
Předmět: |
Adult
medicine.medical_specialty Abdominal pain Constipation Population Placebo-controlled study Administration Oral Colonic Diseases Functional Placebo Gastroenterology Drug Administration Schedule Internal medicine Medicine Humans education Gastrointestinal Transit Irritable bowel syndrome education.field_of_study business.industry General Medicine Middle Aged medicine.disease Treatment Outcome Gastrointestinal disorder Alosetron Receptors Serotonin Female Serotonin Antagonists medicine.symptom Receptors Serotonin 5-HT3 business medicine.drug Carbolines |
Zdroj: | Lancet (London, England). 355(9209) |
ISSN: | 0140-6736 |
Popis: | Summary Background Irritable bowl syndrome (IBS) is a common gastrointestinal disorder with symptoms of abdominal pain, discomfort, and altered bowel function. Antagonists of the type 3 serotonin receptor (5-HT 3 ) have shown promising results in the relief of IBS-associated symptoms. We aimed to confirm these findings by doing a randomised, placebo-controlled trial. 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. |
Databáze: | OpenAIRE |
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