{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T22:49:07Z","timestamp":1792363747383,"version":"4.4.0"},"reference-count":31,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2014,4,3]],"date-time":"2014-04-03T00:00:00Z","timestamp":1396483200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2014,5]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The efficacy of rifaximin, a nonsystemic, gut\u2010targeted antibiotic for reducing non\u2013constipation\u2010predominant irritable bowel syndrome (non\u2010C <jats:styled-content style=\"fixed-case\">IBS<\/jats:styled-content>) symptoms, has been demonstrated in one phase 2b and two phase 3 randomised, double\u2010blind, placebo\u2010controlled trials, but detailed data about rifaximin safety and tolerability during treatment and subsequent follow\u2010up periods are lacking.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess and determine the frequency of rifaximin and placebo adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) in phase 2b and phase 3 non<jats:bold>\u2010<\/jats:bold>C <jats:styled-content style=\"fixed-case\">IBS<\/jats:styled-content> trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A <jats:italic>post hoc<\/jats:italic> pooled safety analysis of the phase 2b (rifaximin 275, 550, and 1100\u00a0mg twice daily for 2\u00a0weeks; 550\u00a0mg twice daily for 4\u00a0weeks) and phase 3 (rifaximin 550\u00a0mg three times daily for 2\u00a0weeks) studies was performed. Data on treatment and post\u2010treatment <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were collected. Patients were followed up for 12\u00a0weeks and 10\u00a0weeks post\u2010treatment in the phase 2b and phase 3 trials, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Patients receiving rifaximin (<jats:italic>n\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>1103) and placebo (<jats:italic>n\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>829) had a similar incidence of drug\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (12.1% vs. 10.7%), serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (1.5% vs. 2.2%), drug\u2010related <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s resulting in study discontinuation (0.8% vs. 0.8%), gastrointestinal\u2010associated <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (12.2% vs. 12.2%) and infection\u2010associated <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s (8.5% vs. 9.5%). There were no cases of <jats:italic>Clostridium difficile<\/jats:italic> colitis or deaths.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The safety and tolerability profile of rifaximin during treatment and post\u2010treatment was comparable to placebo. Future research should define the safety and tolerability profile, including risk of <jats:italic>C. difficile<\/jats:italic> colitis and microbial antibiotic resistance, with repeated courses of rifaximin in patients with non\u2014constipation\u2010predominant irritable bowel syndrome (ClinicalTrials.gov: <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00269412, <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00731679, and <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00724126).<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.12735","type":"journal-article","created":{"date-parts":[[2014,4,4]],"date-time":"2014-04-04T02:08:42Z","timestamp":1396577322000},"page":"1161-1168","source":"Crossref","is-referenced-by-count":93,"title":["Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double\u2010blind, placebo\u2010controlled trials"],"prefix":"10.1111","volume":"39","author":[{"given":"P.","family":"Schoenfeld","sequence":"first","affiliation":[{"name":"University of Michigan School of Medicine Ann Arbor MI USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Pimentel","sequence":"additional","affiliation":[{"name":"Cedars\u2010Sinai Medical Center Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Chang","sequence":"additional","affiliation":[{"name":"David Geffen School of Medicine at UCLA Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Lembo","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center Boston MA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. 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