TY - JOUR
T1 - Repeat treatment with rifaximin improves irritable bowel syndrome-related quality of life
T2 - A secondary analysis of a randomized, double-blind, placebo-controlled trial
AU - Cash, Brooks D.
AU - Pimentel, Mark
AU - Rao, Satish Sanku Chander
AU - Weinstock, Leonard
AU - Chang, Lin
AU - Heimanson, Zeev
AU - Lembo, Anthony
N1 - Funding Information:
Technical editorial assistance was provided, under the direction of the authors, by Mary Beth Moncrief, PhD, and Sophie Bolick, PhD, Synchrony Medical Communications, LLC, West Chester, Pennsylvania, USA. Funding for this support was provided by Salix Pharmaceuticals, Bridgewater, NJ, USA.
Funding Information:
This study was funded by Salix Pharmaceuticals, Bridgewater, NJ, USA.
Funding Information:
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.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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 (3/430% improvement from baseline in mean weekly pain score) and stool consistency (3/450% decrease from baseline in number of days/week with Bristol Stool Scale (BSS) type 6 or 7 stools) during 3/42 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; 3/414-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].
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 (3/430% improvement from baseline in mean weekly pain score) and stool consistency (3/450% decrease from baseline in number of days/week with Bristol Stool Scale (BSS) type 6 or 7 stools) during 3/42 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; 3/414-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].
KW - diarrhea
KW - irritable bowel syndrome
KW - quality of life
UR - http://www.scopus.com/inward/record.url?scp=85029334047&partnerID=8YFLogxK
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U2 - 10.1177/1756283X17726087
DO - 10.1177/1756283X17726087
M3 - Article
AN - SCOPUS:85029334047
VL - 10
SP - 689
EP - 699
JO - Therapeutic Advances in Gastroenterology
JF - Therapeutic Advances in Gastroenterology
SN - 1756-283X
IS - 9
ER -