PMID- 28932270 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20240327 IS - 1756-283X (Print) IS - 1756-2848 (Electronic) IS - 1756-283X (Linking) VI - 10 IP - 9 DP - 2017 Sep TI - Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life: a secondary analysis of a randomized, double-blind, placebo-controlled trial. PG - 689-699 LID - 10.1177/1756283X17726087 [doi] AB - 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]. FAU - Cash, Brooks D AU - Cash BD AD - University of South Alabama, Digestive Health Center, 75 S. University Blvd, Suite 6000-B, Mobile, AL 36608, USA. FAU - Pimentel, Mark AU - Pimentel M AD - GI Motility Program, Division of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, CA, USA. FAU - Rao, Satish S C AU - Rao SSC AD - Section of Gastroenterology/Hepatology, Digestive Health Center, Medical College of Georgia Augusta University, Augusta, GA, USA. FAU - Weinstock, Leonard AU - Weinstock L AD - Specialists in Gastroenterology, LLC, Washington University School of Medicine, St Louis, MO, USA. FAU - Chang, Lin AU - Chang L AD - Division of Digestive Diseases/Gastroenterology, David Geffen School of Medicine at UCLA, UCLA, Los Angeles, CA, USA. FAU - Heimanson, Zeev AU - Heimanson Z AD - Salix Pharmaceuticals, Bridgewater, NJ, USA. FAU - Lembo, Anthony AU - Lembo A AD - Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA. LA - eng SI - ClinicalTrials.gov/NCT01543178 PT - Journal Article DEP - 20170911 PL - England TA - Therap Adv Gastroenterol JT - Therapeutic advances in gastroenterology JID - 101478893 PMC - PMC5598815 OTO - NOTNLM OT - diarrhea OT - irritable bowel syndrome OT - quality of life COIS- Conflict of interest statement: Brooks Cash has served as a speaker, consultant, or as an advisory board member for Salix Pharmaceuticals and Valeant, Bridgewater, NJ; Takeda, Deerfield, IL; Ironwood, Boston, MA; AstraZeneca, Wilmington, DE; Allergan, Parsippany, NJ; and IM HealthSciences, LLC, Boca Raton, FL. Mark Pimentel has served as a consultant for and has received research funding from Salix Pharmaceuticals, Bridgewater, NJ. In addition, Cedars-Sinai Medical Center, Los Angeles, CA, has a licensing agreement with Salix Pharmaceuticals, Bridgewater, NJ. Satish Rao has received a research grant for rifaximin in IBS from Salix Pharmaceuticals, Bridgewater, NJ. Leonard Weinstock has served on the speakers' bureau for Salix Pharmaceuticals, Bridgewater, NJ; Entera Health, Cary, NC; Allergan, Parsippany, NJ; and Romark Labs, Tampa, FL; and is a primary investigator on a rifaximin trial for IBS for Salix Pharmaceuticals, Bridgewater, NJ. Lin Chang has served on scientific advisory boards for Ironwood, Boston, MA; IM HealthSciences, LLC, Boca Raton, FL; BioAmerica, Miami, FL; Synthetics Biologics, Rockville, MD; and Synergy Pharmaceuticals Inc, New York, NY. She has served as a speaker for a Takeda (Deerfield, IL) CME conference and an Allergan (Parsippany, NJ) symposium. Zeev Heimanson is an employee of Salix Pharmaceuticals, Bridgewater, NJ. Anthony Lembo has served as a consultant and an advisory board member for Salix Pharmaceuticals and Valeant, Bridgewater, NJ; Ironwood, Boston, MA; Forest, New York, NY; Allergan, Parsippany, NJ; Prometheus, San Diego, CA; Alkermes, Waltham, MA; AstraZeneca, Wilmington, DE; and Ardelyx, Fremont, CA. EDAT- 2017/09/22 06:00 MHDA- 2017/09/22 06:01 PMCR- 2017/09/01 CRDT- 2017/09/22 06:00 PHST- 2017/02/27 00:00 [received] PHST- 2017/07/05 00:00 [accepted] PHST- 2017/09/22 06:00 [entrez] PHST- 2017/09/22 06:00 [pubmed] PHST- 2017/09/22 06:01 [medline] PHST- 2017/09/01 00:00 [pmc-release] AID - 10.1177_1756283X17726087 [pii] AID - 10.1177/1756283X17726087 [doi] PST - ppublish SO - Therap Adv Gastroenterol. 2017 Sep;10(9):689-699. doi: 10.1177/1756283X17726087. Epub 2017 Sep 11.