Rifaximin-extended intestinal release induces remission in patients with moderately active Crohn's disease
Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved..
BACKGROUND & AIMS: Bacteria might be involved in the development and persistence of inflammation in patients with Crohn's disease (CD), and antibiotics could be used in therapy. We performed a clinical phase 2 trial to determine whether a gastroresistant formulation of rifaximin (extended intestinal release [EIR]) induced remission in patients with moderately active CD.
METHODS: We performed a multicenter, randomized, double-blind trial of the efficacy and safety of 400, 800, and 1200 mg rifaximin-EIR, given twice daily to 402 patients with moderately active CD for 12 weeks. Data from patients given rifaximin-EIR were compared with those from individuals given placebo, and collected during a 12-week follow-up period. The primary end point was remission (Crohn's Disease Activity Index <150) at the end of the treatment period.
RESULTS: At the end of the 12-week treatment period, 62% of patients who received the 800-mg dosage of rifaximin-EIR (61 of 98) were in remission, compared with 43% of patients who received placebo (43 of 101) (P = .005). A difference was maintained throughout the 12-week follow-up period (45% [40 of 89] vs 29% [28 of 98]; P = .02). Remission was achieved by 54% (56 of 104) and 47% (47 of 99) of the patients given the 400-mg and 1200-mg dosages of rifaximin-EIR, respectively; these rates did not differ from those of placebo. Patients given the 400-mg and 800-mg dosages of rifaximin-EIR had low rates of withdrawal from the study because of adverse events; rates were significantly higher among patients given the 1200-mg dosage (16% [16 of 99]).
CONCLUSIONS: Administration of 800 mg rifaximin-EIR twice daily for 12 weeks induced remission with few adverse events in patients with moderately active CD.
| Errataetall: |
CommentIn: Nat Rev Gastroenterol Hepatol. 2012 Feb;9(2):62. - PMID 22249735 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2012 |
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| Erschienen: |
2012 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:142 |
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| Enthalten in: |
Gastroenterology - 142(2012), 3 vom: 01. März, Seite 473-481.e4 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Prantera, Cosimo [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 09.05.2012 Date Revised 09.04.2022 published: Print-Electronic ClinicalTrials.gov: NCT00528073 CommentIn: Nat Rev Gastroenterol Hepatol. 2012 Feb;9(2):62. - PMID 22249735 Citation Status MEDLINE |
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| doi: |
10.1053/j.gastro.2011.11.032 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Rifaximin-extended intestinal release induces remission in patients with moderately active Crohn's disease |
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| 500 | |a Date Revised 09.04.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00528073 | ||
| 500 | |a CommentIn: Nat Rev Gastroenterol Hepatol. 2012 Feb;9(2):62. - PMID 22249735 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND & AIMS: Bacteria might be involved in the development and persistence of inflammation in patients with Crohn's disease (CD), and antibiotics could be used in therapy. We performed a clinical phase 2 trial to determine whether a gastroresistant formulation of rifaximin (extended intestinal release [EIR]) induced remission in patients with moderately active CD | ||
| 520 | |a METHODS: We performed a multicenter, randomized, double-blind trial of the efficacy and safety of 400, 800, and 1200 mg rifaximin-EIR, given twice daily to 402 patients with moderately active CD for 12 weeks. Data from patients given rifaximin-EIR were compared with those from individuals given placebo, and collected during a 12-week follow-up period. The primary end point was remission (Crohn's Disease Activity Index <150) at the end of the treatment period | ||
| 520 | |a RESULTS: At the end of the 12-week treatment period, 62% of patients who received the 800-mg dosage of rifaximin-EIR (61 of 98) were in remission, compared with 43% of patients who received placebo (43 of 101) (P = .005). A difference was maintained throughout the 12-week follow-up period (45% [40 of 89] vs 29% [28 of 98]; P = .02). Remission was achieved by 54% (56 of 104) and 47% (47 of 99) of the patients given the 400-mg and 1200-mg dosages of rifaximin-EIR, respectively; these rates did not differ from those of placebo. Patients given the 400-mg and 800-mg dosages of rifaximin-EIR had low rates of withdrawal from the study because of adverse events; rates were significantly higher among patients given the 1200-mg dosage (16% [16 of 99]) | ||
| 520 | |a CONCLUSIONS: Administration of 800 mg rifaximin-EIR twice daily for 12 weeks induced remission with few adverse events in patients with moderately active CD | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Video-Audio Media | |
| 650 | 7 | |a Anti-Infective Agents |2 NLM | |
| 650 | 7 | |a Delayed-Action Preparations |2 NLM | |
| 650 | 7 | |a Gastrointestinal Agents |2 NLM | |
| 650 | 7 | |a Rifamycins |2 NLM | |
| 650 | 7 | |a Rifaximin |2 NLM | |
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| 700 | 1 | |a Lochs, Herbert |e verfasserin |4 aut | |
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| 700 | 0 | |a Retic Study Group (Rifaximin-Eir Treatment in Crohn's Disease) |e verfasserin |4 aut | |
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| 700 | 1 | |a Bouhnik, Y |e investigator |4 oth | |
| 700 | 1 | |a Lerebours, E |e investigator |4 oth | |
| 700 | 1 | |a Bokemeyer, B |e investigator |4 oth | |
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| 700 | 1 | |a Boecker, U |e investigator |4 oth | |
| 700 | 1 | |a Malfertheiner, P |e investigator |4 oth | |
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| 700 | 1 | |a Tsodikov, G |e investigator |4 oth | |
| 700 | 1 | |a Ivashkin, V |e investigator |4 oth | |
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