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Treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) with rifaximin 550 mg three times daily for 2 weeks was effective in two randomized controlled trials. The current industry-funded study was designed to test whether patients with an initial response to rifaximin will respond to retreatment for relapse.
In 270 centers in the U.S. and Europe, 2579 patients were treated with open-label rifaximin and 1074 (44%) responded, meeting the prespecified abdominal pain and stool consistency composite endpoint. Of these responders, 692 (64%) relapsed within an 18-week observation interval, of whom 636 were randomized to rifaximin 550 mg three times daily or placebo for 2 weeks. Response to retreatment, the primary endpoint, was a decreas…