Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Anthony Lembo, Mark Pimentel, Satish S. Rao, Philip Schoenfeld, Brooks Cash, Leonard B. Weinstock, Craig Paterson, Enoch Bortey, William P. Forbes

Research output: Contribution to journalArticle

84 Citations (Scopus)

Abstract

Background & Aims Few treatments have demonstrated efficacy and safety for diarrhea-predominant irritable bowel syndrome (IBS-D). A phase 3, randomized, double-blind, placebo-controlled trial was performed to evaluate the safety and efficacy of repeat treatment with the nonsystemic antibiotic rifaximin. Methods The trial included adults with IBS-D, mean abdominal pain and bloating scores of 3 or more, and loose stool, located at 270 centers in the United States and Europe from February 2012 through June 2014. Those responding to a 2-week course of open-label rifaximin 550 mg 3 times daily, who then relapsed during an observation phase (up to 18 weeks), were randomly assigned to groups given repeat treatments of rifaximin 550 mg or placebo 3 times daily for 2 weeks. The primary end point was percentage of responders after first repeat treatment, defined as a decrease in abdominal pain of ≥30% from baseline and a decrease in frequency of loose stools of ≥50% from baseline, for 2 or more weeks during a 4-week post-treatment period. Results Of 1074 patients (44.1%) who responded to open-label rifaximin, 382 (35.6%) did not relapse and 692 (64.4%) did; of these, 636 were randomly assigned to receive repeat treatment with rifaximin (n = 328) or placebo (n = 308). The percentage of responders was significantly greater with rifaximin than placebo (38.1% vs 31.5%; P =.03). The percentage of responders for abdominal pain (50.6% vs 42.2%; P =.018) was significantly greater with rifaximin than placebo, but not stool consistency (51.8% vs 50.0%; P =.42). Significant improvements were also noted for prevention of recurrence, durable response, and bowel movement urgency. Adverse event rates were low and similar between groups. Conclusions In a phase 3 study of patients with relapsing symptoms of IBS-D, repeat rifaximin treatment was efficacious and well tolerated. ClinicalTrials.gov ID: NCT01543178.

Original languageEnglish (US)
Pages (from-to)1113-1121
Number of pages9
JournalGastroenterology
Volume151
Issue number6
DOIs
StatePublished - Dec 1 2016

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rifaximin
Irritable Bowel Syndrome
Diarrhea
Placebos
Abdominal Pain
Therapeutics
Safety
Recurrence
Observation

Keywords

  • Bloating
  • Functional Bowel Disease
  • Nonabsorbed
  • Xifaxan

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. / Lembo, Anthony; Pimentel, Mark; Rao, Satish S.; Schoenfeld, Philip; Cash, Brooks; Weinstock, Leonard B.; Paterson, Craig; Bortey, Enoch; Forbes, William P.

In: Gastroenterology, Vol. 151, No. 6, 01.12.2016, p. 1113-1121.

Research output: Contribution to journalArticle

Lembo, A, Pimentel, M, Rao, SS, Schoenfeld, P, Cash, B, Weinstock, LB, Paterson, C, Bortey, E & Forbes, WP 2016, 'Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome', Gastroenterology, vol. 151, no. 6, pp. 1113-1121. https://doi.org/10.1053/j.gastro.2016.08.003
Lembo, Anthony ; Pimentel, Mark ; Rao, Satish S. ; Schoenfeld, Philip ; Cash, Brooks ; Weinstock, Leonard B. ; Paterson, Craig ; Bortey, Enoch ; Forbes, William P. / Repeat Treatment With Rifaximin Is Safe and Effective in Patients With Diarrhea-Predominant Irritable Bowel Syndrome. In: Gastroenterology. 2016 ; Vol. 151, No. 6. pp. 1113-1121.
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abstract = "Background & Aims Few treatments have demonstrated efficacy and safety for diarrhea-predominant irritable bowel syndrome (IBS-D). A phase 3, randomized, double-blind, placebo-controlled trial was performed to evaluate the safety and efficacy of repeat treatment with the nonsystemic antibiotic rifaximin. Methods The trial included adults with IBS-D, mean abdominal pain and bloating scores of 3 or more, and loose stool, located at 270 centers in the United States and Europe from February 2012 through June 2014. Those responding to a 2-week course of open-label rifaximin 550 mg 3 times daily, who then relapsed during an observation phase (up to 18 weeks), were randomly assigned to groups given repeat treatments of rifaximin 550 mg or placebo 3 times daily for 2 weeks. The primary end point was percentage of responders after first repeat treatment, defined as a decrease in abdominal pain of ≥30{\%} from baseline and a decrease in frequency of loose stools of ≥50{\%} from baseline, for 2 or more weeks during a 4-week post-treatment period. Results Of 1074 patients (44.1{\%}) who responded to open-label rifaximin, 382 (35.6{\%}) did not relapse and 692 (64.4{\%}) did; of these, 636 were randomly assigned to receive repeat treatment with rifaximin (n = 328) or placebo (n = 308). The percentage of responders was significantly greater with rifaximin than placebo (38.1{\%} vs 31.5{\%}; P =.03). The percentage of responders for abdominal pain (50.6{\%} vs 42.2{\%}; P =.018) was significantly greater with rifaximin than placebo, but not stool consistency (51.8{\%} vs 50.0{\%}; P =.42). Significant improvements were also noted for prevention of recurrence, durable response, and bowel movement urgency. Adverse event rates were low and similar between groups. Conclusions In a phase 3 study of patients with relapsing symptoms of IBS-D, repeat rifaximin treatment was efficacious and well tolerated. ClinicalTrials.gov ID: NCT01543178.",
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AU - Cash, Brooks

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AU - Bortey, Enoch

AU - Forbes, William P.

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N2 - Background & Aims Few treatments have demonstrated efficacy and safety for diarrhea-predominant irritable bowel syndrome (IBS-D). A phase 3, randomized, double-blind, placebo-controlled trial was performed to evaluate the safety and efficacy of repeat treatment with the nonsystemic antibiotic rifaximin. Methods The trial included adults with IBS-D, mean abdominal pain and bloating scores of 3 or more, and loose stool, located at 270 centers in the United States and Europe from February 2012 through June 2014. Those responding to a 2-week course of open-label rifaximin 550 mg 3 times daily, who then relapsed during an observation phase (up to 18 weeks), were randomly assigned to groups given repeat treatments of rifaximin 550 mg or placebo 3 times daily for 2 weeks. The primary end point was percentage of responders after first repeat treatment, defined as a decrease in abdominal pain of ≥30% from baseline and a decrease in frequency of loose stools of ≥50% from baseline, for 2 or more weeks during a 4-week post-treatment period. Results Of 1074 patients (44.1%) who responded to open-label rifaximin, 382 (35.6%) did not relapse and 692 (64.4%) did; of these, 636 were randomly assigned to receive repeat treatment with rifaximin (n = 328) or placebo (n = 308). The percentage of responders was significantly greater with rifaximin than placebo (38.1% vs 31.5%; P =.03). The percentage of responders for abdominal pain (50.6% vs 42.2%; P =.018) was significantly greater with rifaximin than placebo, but not stool consistency (51.8% vs 50.0%; P =.42). Significant improvements were also noted for prevention of recurrence, durable response, and bowel movement urgency. Adverse event rates were low and similar between groups. Conclusions In a phase 3 study of patients with relapsing symptoms of IBS-D, repeat rifaximin treatment was efficacious and well tolerated. ClinicalTrials.gov ID: NCT01543178.

AB - Background & Aims Few treatments have demonstrated efficacy and safety for diarrhea-predominant irritable bowel syndrome (IBS-D). A phase 3, randomized, double-blind, placebo-controlled trial was performed to evaluate the safety and efficacy of repeat treatment with the nonsystemic antibiotic rifaximin. Methods The trial included adults with IBS-D, mean abdominal pain and bloating scores of 3 or more, and loose stool, located at 270 centers in the United States and Europe from February 2012 through June 2014. Those responding to a 2-week course of open-label rifaximin 550 mg 3 times daily, who then relapsed during an observation phase (up to 18 weeks), were randomly assigned to groups given repeat treatments of rifaximin 550 mg or placebo 3 times daily for 2 weeks. The primary end point was percentage of responders after first repeat treatment, defined as a decrease in abdominal pain of ≥30% from baseline and a decrease in frequency of loose stools of ≥50% from baseline, for 2 or more weeks during a 4-week post-treatment period. Results Of 1074 patients (44.1%) who responded to open-label rifaximin, 382 (35.6%) did not relapse and 692 (64.4%) did; of these, 636 were randomly assigned to receive repeat treatment with rifaximin (n = 328) or placebo (n = 308). The percentage of responders was significantly greater with rifaximin than placebo (38.1% vs 31.5%; P =.03). The percentage of responders for abdominal pain (50.6% vs 42.2%; P =.018) was significantly greater with rifaximin than placebo, but not stool consistency (51.8% vs 50.0%; P =.42). Significant improvements were also noted for prevention of recurrence, durable response, and bowel movement urgency. Adverse event rates were low and similar between groups. Conclusions In a phase 3 study of patients with relapsing symptoms of IBS-D, repeat rifaximin treatment was efficacious and well tolerated. ClinicalTrials.gov ID: NCT01543178.

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