Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double‐blind, placebo‐controlled trials. Issue 10 (3rd April 2014)

• Record Type: Journal Article
• Authors: Schoenfeld, P.; Pimentel, M.; Chang, L.; Lembo, A.; Chey, W. D.; Yu, J.; Paterson, C.; Bortey, E.; Forbes, W. P.
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 39:Issue 10(2014)
• Page Start: 1161
• Page End: 1168
• Publication Date: 2014-04-03
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.12735
• Languages: English
• ISSNs: 0269-2813

Abstract

<abstract abstract-type="main" id="apt12735-abs-0001"> <title>Summary</title> <sec id="apt12735-sec-0001" sec-type="section"> <title>Background</title> <p>The efficacy of rifaximin, a nonsystemic, gut‐targeted antibiotic for reducing non–constipation‐predominant irritable bowel syndrome (non‐C IBS) symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, double‐blind, placebo‐controlled trials, but detailed data about rifaximin safety and tolerability during treatment and subsequent follow‐up periods are lacking.</p> </sec> <sec id="apt12735-sec-0002" sec-type="section"> <title>Aim</title> <p>To assess and determine the frequency of rifaximin and placebo adverse events (AEs) in phase 2b and phase 3 non<bold>‐</bold>C IBS trials.</p> </sec> <sec id="apt12735-sec-0003" sec-type="section"> <title>Methods</title> <p>A <italic>post hoc</italic> pooled safety analysis of the phase 2b (rifaximin 275, 550, and 1100 mg twice daily for 2 weeks; 550 mg twice daily for 4 weeks) and phase 3 (rifaximin 550 mg three times daily for 2 weeks) studies was performed. Data on treatment and post‐treatment AEs were collected. Patients were followed up for 12 weeks and 10 weeks post‐treatment in the phase 2b and phase 3 trials, respectively.</p> </sec> <sec id="apt12735-sec-0004" sec-type="section"> <title>Results</title> <p>Patients receiving rifaximin (<italic>n </italic>=<italic> </italic>1103) and placebo (<italic>n </italic>=<italic> </italic>829) had a similar incidence of drug‐related AEs (12.1% vs. 10.7%), serious AEs (1.5% vs. 2.2%), drug‐related AEs resulting in study discontinuation (0.8% vs. 0.8%), gastrointestinal‐associated AEs (12.2% vs. 12.2%) and infection‐associated AEs (8.5% vs. 9.5%). There were no cases of <italic>Clostridium difficile</italic> colitis or deaths.</p> </sec> <sec id="apt12735-sec-0005" sec-type="section"> <title>Conclusions</title> <p>The safety and tolerability profile of rifaximin during treatment and post‐treatment was comparable to placebo. Future research should define the safety and tolerability profile, including risk of <italic>C. difficile</italic> colitis and microbial antibiotic resistance, with repeated courses of rifaximin in patients with non—constipation‐predominant irritable bowel syndrome (ClinicalTrials.gov: NCT00269412, NCT00731679, and NCT00724126).</p> </sec> </abstract>