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Emeran A. Mayer – One of the best experts on this subject based on the ideXlab platform.

  • Neural and psychological predictors of treatment response in irritable bowel syndrome patients with a 5-HT3 receptor antagonist: a pilot study
    Alimentary pharmacology & therapeutics, 2008
    Co-Authors: Johanna M. Jarcho, Lin Chang, Bruce D. Naliboff, Steve M. Berman, Brandall Y. Suyenobu, M. Mandelkern, Matthew D. Lieberman, V. Z. Ameen, Emeran A. Mayer
    Abstract:

    Aliment Pharmacol Ther 28, 344–352 Summary Background  Symptom improvement in irritable bowel syndrome (IBS) treatment trials varies widely, with only 50–70% of patients qualifying as responders. Factors predicting treatment responsiveness are not known, although we have demonstrated that symptom improvement with the 5-HT3R antagonist Alosetron is correlated with reduced amygdala activity. Aim  To determine whether neural activity during rectal discomfort or psychological distress predicts symptom improvement following treatment with Alosetron. Methods  Basal psychological distress and neural activity (15O PET) during uncomfortable rectal stimulation were measured in 17 nonconstipated IBS patients who then received 3 weeks of Alosetron treatment. Results  Greater symptom improvement was predicted by less activity in bilateral orbitofrontal cortex (OFC) and medial temporal gyrus during pre-treatment scans. Lower levels of interpersonal sensitivity predicted greater symptom improvement and were positively related to activity in left OFC. Connectivity analysis revealed a positive relationship between activity in the left OFC and right amygdala. Conclusions  Irritable bowel disease symptom improvement with 5-HT3R antagonist Alosetron is related to pre-treatment reactivity of the left OFC, which may be partially captured by subjective measures of interpersonal sensitivity. The left OFC may fail to modulate amygdala response to visceral stimulation, thereby diminishing effectiveness of treatment. Psychological factors and their neurobiological correlates are plausible predictors of IBS treatment outcome.

  • Dual role of 5-HT3 receptors in a rat model of delayed stress-induced visceral hyperalgesia.
    Pain, 2007
    Co-Authors: Sylvie Bradesi, Lijun Lao, Peter G. Mclean, Wendy J. Winchester, Kevin Lee, Gareth A. Hicks, Emeran A. Mayer
    Abstract:

    Despite its beneficial effect in IBS patients, the mechanism of action of the 5-HT3 receptor (5-HT3R) antagonist Alosetron is still incompletely understood. We aimed to characterize the effect and site(s) of action in a model of stress-induced sensitization of visceral nociception in rats. Adult male Wistar rats were equipped for recording of visceromotor response (VMR) to phasic colorectal distension (CRD; 10-60 mmHg). VMR to CRD was recorded 24 h after an acute session of water avoidance (WA) stress (post-WA). Baseline and post-WA responses were measured in rats exposed to WA or sham-WA, treated with Alosetron at 0.3 mg/kg subcutaneously (s.c.) 25 nmol intrathecally (i.t.) or vehicle before post-WA CRD. Some rats were treated with capsaicin/vehicle on the cervical vagus nerve and received Alosetron (0.3 mg/kg, s.c.) 15 min before post-WA CRD. WA stress led to visceral hyperalgesia 24 h later. Alosetron (0.3 mg/kg, s.c.), failed to inhibit WA-induced exacerbation of VMR to CRD. Stress-induced visceral hyperalgesia was abolished when Alosetron was injected intrathecally (P

  • A dose-ranging, phase II study of the efficacy and safety of Alosetron in men with diarrhea-predominant IBS
    The American journal of gastroenterology, 2005
    Co-Authors: Lin Chang, Vanessa Z. Ameen, David J. Mcsorley, George E. Dukes, Eric G. Carter, Emeran A. Mayer
    Abstract:

    A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

Eric G. Carter – One of the best experts on this subject based on the ideXlab platform.

  • A randomized, double-blind, placebo-controlled study to assess efficacy and safety of 0.5 mg and 1 mg Alosetron in women with severe diarrhea-predominant IBS.
    The American journal of gastroenterology, 2007
    Co-Authors: Richard Krause, Vanessa Z. Ameen, Amy T Heath, Susan H. Gordon, Marquita A. West, T. Perschy, Eric G. Carter
    Abstract:

    A Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of 0.5 mg and 1 mg Alosetron in Women With Severe Diarrhea-predominant IBS

  • A dose-ranging, phase II study of the efficacy and safety of Alosetron in men with diarrhea-predominant IBS
    The American journal of gastroenterology, 2005
    Co-Authors: Lin Chang, Vanessa Z. Ameen, David J. Mcsorley, George E. Dukes, Eric G. Carter, Emeran A. Mayer
    Abstract:

    A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

  • Effect of Alosetron on bowel urgency and global symptoms in women with severe, diarrhea-predominant irritable bowel syndrome: analysis of two controlled trials.
    Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2004
    Co-Authors: Anthony Lembo, Vanessa Z. Ameen, Amy T Heath, Kevin W. Olden, Susan Gordon, Eric G. Carter
    Abstract:

    Abstract Background & Aims : The aim of this study was to assess the effect of Alosetron on bowel urgency and irritable bowel syndrome (IBS) global improvement in diarrhea-predominant IBS (D-IBS). Methods : Women with a lack of satisfactory bowel urgency control at least 50% of the time during screening were randomized to receive Alosetron 1 mg (n = 246) or placebo (n = 246) twice daily. The primary end point was the percentage of days with satisfactory control of bowel urgency. The response rate for the IBS global improvement scale (GIS) was a secondary end point. GIS responders were patients who recorded either moderate or substantial improvement in IBS symptoms relative to the way they felt before entering the study. Other end points included improvement in stool frequency, stool consistency, and percentage of days with incomplete evacuation. Further analyses were performed on a subset of patients who had at least 10 of 14 days during screening (≥71% of days) with a lack of satisfactory control of bowel urgency. Results : Patients had severe chronic IBS symptoms, and 89% of patients had D-IBS. Alosetron resulted in a greater percentage of days with satisfactory control of urgency compared with placebo (69% vs. 56%, respectively, P Conclusions : Alosetron effectively manages bowel urgency and improves global symptoms in women with severe chronic D-IBS.

George E. Dukes – One of the best experts on this subject based on the ideXlab platform.

  • A dose-ranging, phase II study of the efficacy and safety of Alosetron in men with diarrhea-predominant IBS
    The American journal of gastroenterology, 2005
    Co-Authors: Lin Chang, Vanessa Z. Ameen, David J. Mcsorley, George E. Dukes, Eric G. Carter, Emeran A. Mayer
    Abstract:

    A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

  • Long-term safety and efficacy of Alosetron in women with severe diarrhea-predominant irritable bowel syndrome.
    The American journal of gastroenterology, 2004
    Co-Authors: William D. Chey, William Y. Chey, Amy T Heath, George E. Dukes, Eric G. Carter, Northcutt Allison Ruth, Vanessa Z. Ameen
    Abstract:

    Long-Term Safety and Efficacy of Alosetron in Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome

  • a randomized controlled clinical trial of the serotonin type 3 receptor antagonist Alosetron in women with diarrhea predominant irritable bowel syndrome
    JAMA Internal Medicine, 2001
    Co-Authors: Michael Camilleri, Emeran A. Mayer, A.r. Northcutt, William Y. Chey, George E. Dukes, At Heath, David Mcsorley, Allen M Mangel
    Abstract:

    Background Irritable bowel syndrome (IBS) is a common gastrointestinal disorder seen in primary care practice. The symptoms of IBS, including abdominal pain, discomfort, and abnormal bowel function, may be modulated by activity of the serotonin type 3 receptor (5-HT 3 ). The efficacy and tolerability of the 5-HT 3 receptor antagonist Alosetron hydrochloride in nonconstipated female patients with IBS were evaluated in a double-blind, randomized, placebo-controlled trial. 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 Conclusion 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.

Michael Camilleri – One of the best experts on this subject based on the ideXlab platform.

  • Efficacy of Alosetron in irritable bowel syndrome: a meta-analysis of randomized controlled trials.
    Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society, 2003
    Co-Authors: Filippo Cremonini, Silvia Delgado-aros, Michael Camilleri
    Abstract:

    The 5HT3 receptor antagonist Alosetron has been tested in several trials on irritable bowel syndrome (IBS) patients. The aim of the present meta-analysis was to determine its effect on adequate relief of pain or global improvement of symptoms in IBS patients. Six large, multicentre, randomized, placebo-controlled trials fulfilled pre-set criteria for high quality and were included in the meta-analysis; 1762 patients were randomized to Alosetron treatment and 1356 to placebo. Seventy-five per cent of the patients experienced diarrhoea-predominant IBS and 93% were females. The pooled odds ratio for adequate relief of pain or global symptoms improvement was 1.81 [95% confidence interval (CI) 1.57-2.10). The average number of patients needed to treat with Alosetron for one patient to achieve improvement over placebo treatment was seven (95% CI 5.74-9.43). The present analysis shows that Alosetron 1 mg b.i.d. positively impacts global symptoms, and pain and discomfort in non-constipated IBS female patients. One in four patients treated with Alosetron may develop constipation. The efficacy of Alosetron is unclear in male patients.

  • Effects of 5‐HT3 antagonism on postprandial gastric volume and symptoms in humans
    Alimentary pharmacology & therapeutics, 2002
    Co-Authors: B. Kuo, Michael Camilleri, D.d. Burton, Blanca E. Viramontes, S. Mckinzie, G. Thomforde, Michael K. O'connor, Benjamin H. Brinkmann
    Abstract:

    Background: Alosetron reduces symptoms of dyspepsia, but the physiological basis for the symptomatic benefit is unclear. Aim: To assess 5-HT3 antagonism on postprandial gastric volume and symptoms after ingestion of maximum tolerable volume of a liquid meal. Methods: In 36 healthy volunteers, we assessed effects of placebo, 0.5 and 1 mg b.d. Alosetron on fasting and postprandial gastric volumes (using single photphoton emission computed tomography) and symptoms based on 100 mm VAS, 30 min after maximum volume ingested. Results: The 5-HT3 antagonist reduced postprandial symptoms (aggregate score: P 

  • a randomized controlled clinical trial of the serotonin type 3 receptor antagonist Alosetron in women with diarrhea predominant irritable bowel syndrome
    JAMA Internal Medicine, 2001
    Co-Authors: Michael Camilleri, Emeran A. Mayer, A.r. Northcutt, William Y. Chey, George E. Dukes, At Heath, David Mcsorley, Allen M Mangel
    Abstract:

    Background Irritable bowel syndrome (IBS) is a common gastrointestinal disorder seen in primary care practice. The symptoms of IBS, including abdominal pain, discomfort, and abnormal bowel function, may be modulated by activity of the serotonin type 3 receptor (5-HT 3 ). The efficacy and tolerability of the 5-HT 3 receptor antagonist Alosetron hydrochloride in nonconstipated female patients with IBS were evaluated in a double-blind, randomized, placebo-controlled trial. 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 Conclusion 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.

Lin Chang – One of the best experts on this subject based on the ideXlab platform.

  • Published by Blackwell Publishing Incidence of Ischemic Colitis and Serious Complications of Constipation Among Patients Using Alosetron: Systematic Review of Clinical Trials and Post-Marketing Surveillance Data
    , 2014
    Co-Authors: Lin Chang, Philip Schoenfeld, William D. Chey, Christina M. Surawicz, Lucinda Harris, Kevin Olden, M. S.
    Abstract:

    BACKGROUND: Ischemic colitis and serious complications of constipation have been reported in association with the use of Alosetron, which is approved for women with severe diarrhea-predominant IBS who have failed conventional therapies. This systematic review calculated the incidence of these adverse events in Alosetron-using patients in clinical trials and post-marketing surveillance. METHODS: A panel of experts in epidemiology and functional bowel disorders reviewed clinical trial report forms and FDA MedWatch forms of each reported case of ischemic colitis or serious complications of constipation. Experts were blinded about whether patients used Alosetron or placebo. Using pre-specified criteria, experts rated the likelihood of an accurate diagnosis and an association between medication use and adverse events. Cases that were not consistent with the reported diagnosis or not possibly associated with medication use were eliminated from calculation of incidence rates of adverse events. RESULTS: Pooled data from clinical trials indicate an increased rate of ischemic colitis among Alosetron-using patients compared to placebo-using patients (0.15 % vs 0.0%, respectively, p = 0.03), but there was no significant difference in the rate of serious complications of constipation. All (19/19

  • An Evidence-Based Look at Misconceptions in the Treatment of Patients with IBS-D.
    Gastroenterology & hepatology, 2013
    Co-Authors: Brian E. Lacy, William D. Chey, Lin Chang
    Abstract:

    Irritable bowel syndrome (IBS) is the most common functional gastrointestinal disorder and affects up to 12% to 15% of adults in the United States, with a higher prevalence among women and those younger than 50 years. IBS adversely impacts quality of life and medical expenditures, with significant costs arising from healthcare visits and reduced workplace productivity. Recent studies have shown that the adverse effects of IBS are so significant that many patients are willing to accept risks of adverse events from effective treatment to gain symptom relief. Alosetron is a 5-HT3 receptor antagonist approved by the US Food and Drug Administration (FDA) for women with severe diarrhea-predominant IBS that has not responded to traditional therapies. Alosetron yields overall improvements in IBS symptoms in 51% of patients vs 36% treated with placebo, with efficacy continuing undiminished over the course of a 48-week randomized, controlled trial. In real-world clinical practice, patients receiving Alosetron had significant improvements in multiple IBS-related clinical parameters, including the new FDA IBS-diarrhea composite endpoint, lower gastrointestinal symptoms, fecal incontinence, and quality of life. Ischemic colitis and complications of constipation have been rare in occurrence. After nearly a decade of Alosetron use under the risk management plan, adjudication of ischemic colitis and complications of constipation cases indicate that their incidence rates have remained low and stable.

  • Ischemic colitis and complications of constipation associated with the use of Alosetron under a risk management plan: clinical characteristics, outcomes, and incidences.
    The American journal of gastroenterology, 2010
    Co-Authors: Lin Chang, Kenneth Tong, Vanessa Z. Ameen
    Abstract:

    Ischemic Colitis and Complications of Constipation Associated With the Use of Alosetron Under a Risk Management Plan: Clinical Characteristics, Outcomes, and Incidences