Abstract

Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life: a secondary analysis of a randomized, double-blind, placebo-controlled trial

Cash BD1, Pimentel M2, Rao SSC3, Weinstock L4, Chang L5, Heimanson Z6, Lembo A7. Therap Adv Gastroenterol. 2017 Sep;10(9):689-699. doi: 10.1177/1756283X17726087. Epub 2017 Sep 11.
 
     
Author information

1 University of South Alabama, Digestive Health Center, 75 S. University Blvd, Suite 6000-B, Mobile, AL 36608, USA. 2 GI Motility Program, Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. 3 Section of Gastroenterology/Hepatology, Digestive Health Center, Medical College of Georgia Augusta University, Augusta, GA, USA. 4 Specialists in Gastroenterology, LLC, Washington University School of Medicine, St Louis, MO, USA. 5 Division of Digestive Diseases/Gastroenterology, David Geffen School of Medicine at UCLA, UCLA, Los Angeles, CA, USA. 6 Salix Pharmaceuticals, Bridgewater, NJ, USA. 7 Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.

Abstract

BACKGROUND: Diarrhea-predominant irritable bowel syndrome (IBS-D) impairs patient quality of life (QOL). Rifaximin is an oral, nonsystemic antibiotic indicated for IBS-D. The objective of this secondary analysis was to evaluate rifaximin retreatment on IBS-related QOL in patients with IBS-D.

METHODS: Patients received open-label rifaximin 550 mg three times daily for 2 weeks. Clinical responders [simultaneously meeting weekly response criteria for abdominal pain (⩾30% improvement from baseline in mean weekly pain score) and stool consistency (⩾50% decrease from baseline in number of days/week with Bristol Stool Scale (BSS) type 6 or 7 stools) during ⩾2 of first 4 weeks posttreatment] who relapsed during an up to 18-week treatment-free observation phase were randomly assigned to receive two 2-week courses of double-blind rifaximin or placebo, separated by 10 weeks. A validated 34-item IBS-QOL questionnaire examined patient responses in 8 domains.

RESULTS: The 2579 patients receiving open-label rifaximin experienced a mean improvement from baseline in IBS-QOL overall score of 54.9%. Responders to open-label rifaximin (n = 1074 of 2438 evaluable; 44.1%) had significantly greater improvement from baseline in IBS-QOL overall and all eight subdomain scores, including dysphoria, food avoidance, interference with activity, body image, and sexual function versus nonresponders at 4 weeks posttreatment (n = 1364; p < 0.001 for all comparisons). A significantly greater percentage of responders to open-label rifaximin achieved the minimally clinically important difference (MCID; ⩾14-point improvement from baseline) in the overall IBS-QOL score versus nonresponders [n = 561 (52.2%) versus n = 287 (21.0%); p < 0.0001]. Among 636 patients with IBS-D relapse, the MCID in the overall IBS-QOL score was achieved by a significantly greater percentage of patients receiving double-blind rifaximin versus placebo (38.6% versus 29.6%, respectively; p = 0.009).

CONCLUSIONS: Open-label and blinded retreatment with a short course (2 weeks) of rifaximin improved IBS-QOL in patients with IBS-D [ClinicalTrials.gov identifier: NCT01543178].

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