Efficacy and safety of alosetron in women with irritable bowel syndrome: A randomised, placebo-controlled trial

Michael Camilleri, Allison R. Northcutt, Steven Kong, George E. Dukes, David McSorley, Allen W. Mangel

Research output: Contribution to journalArticle

499 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1035-1040
Number of pages6
JournalLancet
Volume355
Issue number9209
StatePublished - Mar 25 2000

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Irritable Bowel Syndrome
Randomized Controlled Trials
Placebos
Safety
Constipation
Abdominal Pain
Diarrhea
Receptors, Serotonin, 5-HT3
Intention to Treat Analysis
alosetron
Pain
Therapeutics
Population

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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, 355(9209), 1035-1040.

Efficacy and safety of alosetron in women with irritable bowel syndrome : A randomised, placebo-controlled trial. / Camilleri, Michael; Northcutt, Allison R.; Kong, Steven; Dukes, George E.; McSorley, David; Mangel, Allen W.

In: Lancet, Vol. 355, No. 9209, 25.03.2000, p. 1035-1040.

Research output: Contribution to journalArticle

Camilleri, M, Northcutt, AR, Kong, S, Dukes, GE, McSorley, D & Mangel, AW 2000, 'Efficacy and safety of alosetron in women with irritable bowel syndrome: A randomised, placebo-controlled trial', Lancet, vol. 355, no. 9209, pp. 1035-1040.
Camilleri M, Northcutt AR, Kong S, Dukes GE, McSorley D, Mangel AW. Efficacy and safety of alosetron in women with irritable bowel syndrome: A randomised, placebo-controlled trial. Lancet. 2000 Mar 25;355(9209):1035-1040.
Camilleri, Michael ; Northcutt, Allison R. ; Kong, Steven ; Dukes, George E. ; McSorley, David ; Mangel, Allen W. / Efficacy and safety of alosetron in women with irritable bowel syndrome : A randomised, placebo-controlled trial. In: Lancet. 2000 ; Vol. 355, No. 9209. pp. 1035-1040.
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