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

  title={Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial},
  author={Michael Joseph Camilleri and Allison R. Northcutt and Steven Kong and George E. Dukes and David Mcsorley and Allen Wayne Mangel},
  journal={The Lancet},
A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome.
Alosetron hydrochloride, 1 mg twice daily for 12 weeks, is effective in relieving pain and some bowel-related symptoms in diarrhea-predominant female patients with IBS.
Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome
Alosetron is effective at managing bowel urgency in women with diarrhea-predominant IBS and the IBS Global Improvement assessment correlated with improvements in bowel function and may be a useful tool in future IBS clinical trials.
A randomized, controlled exploratory study of clonidine in diarrhea-predominant irritable bowel syndrome.
  • M. Camilleri, Doe-Young Kim, A. Zinsmeister
  • Medicine
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
  • 2003
Clonidine, 0.1 mg twice a day for 4 weeks, relieves bowel dysfunction and appears promising for relief of D-IBS; these effects are unassociated with significant alterations in transit.
Effect of alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials.
Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea.
Patient satisfaction with alosetron for the treatment of women with diarrhea-predominant irritable bowel syndrome
Women with diarrhea-predominant IBS are satisfied with alosetron 1 mg b.i.d. treatment overall and also with respect to specific attributes of IBS medication they consider most important.
Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women.
In a randomized, placebo-controlled, phase 3 study of 576 women with IBS-D, 2.5 μg ramosetron per day reduced symptoms and increased stool consistency and QOL and patients received significant reductions in abdominal pain and discomfort and greater improvement in QOL compared with placebo.
A randomised controlled trial on hypnotherapy for irritable bowel syndrome: design and methodological challenges (the IMAGINE study)
If hypnotherapy is effective and if there is no difference in efficacy between individual and group hypn therapy, this group form of treatment could be offered to more IBS patients, at lower costs.
Long-Term Safety and Efficacy of Alosetron in Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome
Long-term use of alosetron is effective and well-tolerated in women with chronic, diarrhea-predominant IBS, including those with more frequent urgency, and in weeks without rescue medication use, satisfactory control rates for stool frequency and stool consistency were significantly greater in alosettron-treated patients than placebo.


Adequate Relief as an Endpoint in Clinical Trials in Irritable Bowel Syndrome
Adequate relief of pain and discomfort is significantly correlated with changes in multiple parameters associated with irritable bowel syndrome and can be used as an endpoint for assessing response to therapy in these patients.
Modification of visceral sensitivity and pain in irritable bowel syndrome by 5-HT3 antagonism (ondansetron).
Serotonin-3 antagonism (O), a specific 5-HT3 antagonist, causes firmer bowel actions in all subjects, and may affect gut sensitivity and pain in patients with IBS.
Irritable bowel syndrome in the general population.
Symptoms consistent with a diagnosis of irritable bowel syndrome are present in almost one quarter of the general population and tend to be associated with a number of other complaints and conditions, some of which may reflect smooth muscle dysfunction.
A double‐blind, randomized, placebo‐controlled dose‐ranging study to evaluate the efficacy of alosetron in the treatment of irritable bowel syndrome
Antagonism at the 5‐HT3 receptor may be of benefit in the treatment of irritable bowel syndrome.
Impact of Irritable Bowel Syndrome on Quality of Life and Resource Use in the United States and United Kingdom
IBS has a significant impact on quality of life and resource use in both the US and UK, and appears to be greater in the UK than in the US, while the general health status of persons with IBS in either country was much poorer.
Clinical economics review: irritable bowel syndrome
The ubiquitous nature of irritable bowel syndrome has created the impression that the condition must represent a large drain on health‐care resources, but the literature certainly appears to support this view but is largely based on patients seen in referral centres and it may not be appropriate to extrapolate these data to the IBS population as a whole.
Functional bowel disorders and functional abdominal pain
A committee consensus approach, including criticism from multinational expert reviewers, was used to revise the diagnostic criteria and update diagnosis and treatment recommendations, based on research results.
Selective 5‐hydroxytryptamine antagonism: a role in irritable bowel syndrome and functional dyspepsia?
The aim of this study was to investigate the therapeutic potential of a 5‐HT3 antagonist in irritable bowel syndrome.