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Rifaximin regimen induced Crohn's disease remission
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New findings suggest that a rifaximin extended-intestinal-release regimen induced remission of moderately-active Crohn’s disease.
The results suggest that an 800 mg dose may be safe and effective in moderate cases. However, “the lack of a dose-response relationship and the higher-than-expected placebo response suggest that these findings need to be confirmed from pivotal studies,” the researchers wrote.
The randomized, double-blind trial included patients (n=402) with moderate Crohn’s disease across 55 centers throughout seven countries. Patients, aged between 18 and 75 years, were assigned to one of the following groups: twice-daily placebo (n=101), 400 mg twice-daily rifaximin (n=104), 800 mg twice-daily rifaximin (n=98) or 1,200 mg twice-daily rifaximin (n=99). Remission rates were assessed after the initial 12-week period and at 12 weeks follow-up.
After the initial 12 weeks, 62% of the 800 mg group went into remission compared with 43% of the placebo group (P=.005; OR 2.22; 95% CI, 1.26-3.92). At the end of follow-up, 45% of the 800 mg group and 29% of those assigned placebo maintained remission (P=.02).
Similarities were observed in adverse events across all four groups (44% with placebo and 41% for all treatment groups).
“This was the first large-scale trial to demonstrate efficacy of rifaximin in reducing remission in patients with active [Crohn’s disease],” the researchers wrote.
Disclosure: The researchers report no relevant financial disclosures.
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Prantera R. Gastroenterology. 2012;142:473-481.
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