References
- Papers of special note have been highlighted as either of interest (•) or of considerable interest (••) to readers
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•• Most recent American College of Gastroenterology guidelines on the management of IBS, representing a comprehensive literature review and expert consensus opinion
- Weinberg DS, Smalley W, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the pharmacological management of irritable bowel syndrome. Gastroenterology. 2014;147:1146–1148.
•• Most recent American Gastroenterological Association guidelines on the management of IBS, representing a comprehensive literature review and expert consensus opinion
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•• Report of TARGET 1 and 2 clinical trial data showing benefit and excellent tolerability of rifaximin for non-constipated IBS
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•• Abstract reporting the top-line efficacy and safety results from two randomized controlled trials of eluxadoline for IBS-D
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- US Department of Health and Human Services, Food and Drug Administration, News Release, May 27, 2015: [cited 2015 Jun 3]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm.
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- Salix Investor Day, held 9 July 2014 at the St. Regis Hotel, New York, NY. [cited 2014 Aug 15]. Available from: http://cdn.salix.com/salix/assets/pdf/salix-investor-day.pdf.
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- ClinicalTrials.gov. TARGET 3 trial. [cited 2014 Aug 19]. Available from: http://clinicaltrials.gov/ct2/show/study/NCT01543178?term=target+3&rank=1#locn.
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•• Excellent review of safety and tolerability of rifaximin randomized controlled trials for IBS
- Eluxadoline: Digestive Diseases Week presentation, given 6 May 2014. [cited 2014 Sep 20]. Available from: http://files.shareholder.com/downloads/ABEA-4H9PM3/3215452282x0x752274/f0470ebb-e052-4c0c-ad29-23093ccbc694/View%20presentation.
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• This original article reported substantial reductions over time in the incidence of complications of constipation and in symptoms suggestive of ischemic colitis and complications of constipation, while the incidence of ischemic colitis was reported to be stable at approximately 1.0 case/1000 patient-years. These improvements in the incidence of ischemic colitis and complications of constipation are attributed to the alosetron risk management program
- Camilleri M, Chey WY, Mayer EA, et al. A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome. Arch Intern Med. 2001;161:1733–1740.
- 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;355:1035–1040.
- Camilleri M, Krause R, Deveze S, et al. Evaluation of alosetron using the new FDA composite endpoint demonstrates strong treatment effect in females with severe irritable bowel syndrome with diarrhea. Am J Gastroenterol. 2014;109(Suppl 2):S535.
•• This abstract evaluates the data from alosetron randomized controlled trials with the contemporary FDA Guidance endpoint of simultaneous improvement in abdominal pain and stool form/frequency and confirms benefit with the new composite endpoint
- Krause R, Ameen V, Gordon SH, et al. 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. Am J Gastroenterol. 2007;102:1709–1719.
- Cremonini F, Nicandro JP, Atkinson V, et al. Randomised clinical trial: alosetron improves quality of life and reduces restriction of daily activities in women with severe diarrhoea-predominant IBS. Aliment Pharmacol Ther. 2012;36:437–448.