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Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial.
Lancet. 2000 Mar 25; 355(9209):1035-40.Lct

Abstract

BACKGROUND

Irritable bowel 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-HT3) 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.

Authors+Show Affiliations

Gastrointestinal Research Unit, Mayo Clinic, Rochester, MN, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10744088

Citation

Camilleri, M, et al. "Efficacy and Safety of Alosetron in Women With Irritable Bowel Syndrome: a Randomised, Placebo-controlled Trial." Lancet (London, England), vol. 355, no. 9209, 2000, pp. 1035-40.
Camilleri M, Northcutt AR, Kong S, et al. Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. Lancet. 2000;355(9209):1035-40.
Camilleri, M., Northcutt, A. R., Kong, S., Dukes, G. E., McSorley, D., & Mangel, A. W. (2000). Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. Lancet (London, England), 355(9209), 1035-40.
Camilleri M, et al. Efficacy and Safety of Alosetron in Women With Irritable Bowel Syndrome: a Randomised, Placebo-controlled Trial. Lancet. 2000 Mar 25;355(9209):1035-40. PubMed PMID: 10744088.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. AU - Camilleri,M, AU - Northcutt,A R, AU - Kong,S, AU - Dukes,G E, AU - McSorley,D, AU - Mangel,A W, PY - 2000/4/1/pubmed PY - 2000/4/15/medline PY - 2000/4/1/entrez SP - 1035 EP - 40 JF - Lancet (London, England) JO - Lancet VL - 355 IS - 9209 N2 - BACKGROUND: Irritable bowel 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-HT3) 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. SN - 0140-6736 UR - https://www.unboundmedicine.com/medline/citation/10744088/Efficacy_and_safety_of_alosetron_in_women_with_irritable_bowel_syndrome:_a_randomised_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0140-6736(00)02033-X DB - PRIME DP - Unbound Medicine ER -