# Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation



## Jeffrey Roberts (Apr 15, 1987)

The New England Journal of Medicine Rifaximin Therapy for Patients with Irritable Bowel Syndrome without ConstipationMark Pimentel, M.D., Anthony Lembo, M.D., William D. Chey, M.D., Salam Zakko, M.D., Yehuda Ringel, M.D., Jing Yu, Ph.D., Shadreck M. Mareya, Ph.D., Audrey L. Shaw, Ph.D., Enoch Bortey, Ph.D., and William P. Forbes, Pharm.D. for the TARGET Study GroupN Engl J Med 2011; 364:22-32January 6, 2011Abstract:Evidence suggests that gut flora may play an important role in the pathophysiology of the irritable bowel syndrome (IBS). We evaluated rifaximin, a minimally absorbed antibiotic, as treatment for IBS.In two identically designed, phase 3, double-blind, placebo-controlled trials (TARGET 1 and TARGET 2), patients who had IBS without constipation were randomly assigned to either rifaximin at a dose of 550 mg or placebo, three times daily for 2 weeks, and were followed for an additional 10 weeks. The primary end point, the proportion of patients who had adequate relief of global IBS symptoms, and the key secondary end point, the proportion of patients who had adequate relief of IBS-related bloating, were assessed weekly. Adequate relief was defined as self-reported relief of symptoms for at least 2 of the first 4 weeks after treatment. Other secondary end points included the percentage of patients who had a response to treatment as assessed by daily self-ratings of global IBS symptoms and individual symptoms of bloating, abdominal pain, and stool consistency during the 4 weeks after treatment and during the entire 3 months of the study.Significantly more patients in the rifaximin group than in the placebo group had adequate relief of global IBS symptoms during the first 4 weeks after treatment (40.8% vs. 31.2%, P=0.01, in TARGET 1; 40.6% vs. 32.2%, P=0.03, in TARGET 2; 40.7% vs. 31.7%, P<0.001, in the two studies combined). Similarly, more patients in the rifaximin group than in the placebo group had adequate relief of bloating (39.5% vs. 28.7%, P=0.005, in TARGET 1; 41.0% vs. 31.9%, P=0.02, in TARGET 2; 40.2% vs. 30.3%, P<0.001, in the two studies combined). In addition, significantly more patients in the rifaximin group had a response to treatment as assessed by daily ratings of IBS symptoms, bloating, abdominal pain, and stool consistency. The incidence of adverse events was similar in the two groups.Among patients who had IBS without constipation, treatment with rifaximin for 2 weeks provided significant relief of IBS symptoms, bloating, abdominal pain, and loose or watery stools. (Funded by Salix Pharmaceuticals; ClinicalTrials.gov numbers, NCT00731679 and NCT00724126.)From Cedars-Sinai Medical Center, Los Angeles (M.P.); Beth Israel Deaconess Medical Center and Harvard Medical School - both in Boston (A.L.); University of Michigan Health System, Ann Arbor (W.D.C.); Connecticut Gastroenterology Institute at Bristol Hospital, Bristol (S.Z.); University of North Carolina at Chapel Hill, Chapel Hill (Y.R.); and Salix Pharmaceuticals, Morrisville, NC (J.Y., S.M.M., A.L.S., E.B., W.P.F.).Full article: http://www.nejm.org/...6/NEJMoa1004409EJM.org Copyright © 2011 Massachusetts Medical Society. All rights reserved.


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## Jeffrey Roberts (Apr 15, 1987)

WebMD.com2 Weeks of Antibiotic Therapy Relieves IBSStudy Shows Rifaximin Helps Ease Symptoms of Irritable Bowel SyndromeBy Kathleen DohenyWebMD Health News Reviewed by Laura J. Martin, MDJan. 5, 2011 -- A two-week course of the antibiotic rifaximin (Xifaxan) helps to relieve the symptoms of irritable bowel syndrome (IBS), and the relief lasts up to 10 weeks after stopping the medication, according to new research.''The major finding was that all IBS symptoms improved," says Mark Pimentel, MD, director of the GI Motility Program at Cedars-Sinai Medical Center, Los Angeles, who led the clinical trial of the drug at Cedars.The study looked only at those IBS patients with the non-constipation form, he tells WebMD. For those with this type of IBS, symptoms can include abdominal pain, bloating, and changes in bowel function such as diarrhea.Article Link: http://www.webmd.com/ibs/news/20110105/2-weeks-of-antibiotic-therapy-relieves-ibs


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## Jeffrey Roberts (Apr 15, 1987)

BloombergSalix Pharmaceuticals Says Xifaxan Eases Bowel Syndrome in Company StudiesBy Nicole Ostrow - Jan 5, 2011Salix Pharmaceuticals Ltd.'s antibiotic Xifaxan helped relieve symptoms such as abdominal pain in patients with a type of irritable bowel syndrome, according to two trials funded by the drugmaker.The research involved patients without constipation, half of whom received Xifaxan tablets for two weeks. A total of 41 percent of those getting the drug had relief in at least two of the first four weeks after therapy, compared with 32 percent of people treated with a placebo, researchers said today in the New England Journal of Medicine.At least 30 million people in the U.S. suffer from irritable bowel syndrome, and the most common symptom is diarrhea, said Mark Pimentel, lead author of the study. Most patients are treated with antidepressants, fiber supplements or diet and lifestyle changes, he said. Xifaxan, if approved to combat the syndrome, may help patients who don't have constipation, he said.The drug would be the first "that is treating a causative factor in irritable bowel syndrome," Pimentel, director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles, said Dec. 31 in a telephone interview.Article Link: http://www.bloomberg.com/news/2011-01-05/salix-pharmaceuticals-says-xifaxan-eases-bowel-syndrome-in-company-studies.html


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## Jeffrey Roberts (Apr 15, 1987)

Associated PressAntibiotic shown to relieve common bowel disorder(AP) - 4 hours agoNEW YORK (AP) - New research found that two weeks of treatment with an antibiotic can relieve symptoms for some sufferers of irritable bowel syndrome.The disorder affects as many as 1 in 5 Americans, especially young women. Main symptoms are abdominal pain, bloating and diarrhea or constipation. What causes the disorder has been a mystery.Some scientists think it's caused by an overgrowth of bacteria in the gut but studies have had mixed results. In the new studies, researchers tested the antibiotic rifaximin (ri-FAX'-i-men).They found that 41 percent of patients who took the antibiotic said their symptoms substantially improved. That's compared to 32 percent of participants who took dummy pills.The findings are in Thursday's New England Journal of Medicine.Copyright © 2011 The Associated Press. All rights reserved.


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## Jeffrey Roberts (Apr 15, 1987)

U.S.News & World ReportAntibiotic May Help Ease Irritable BowelDrug offers symptom relief that may last long after treatment stops, study findsPosted: January 5, 2011By Jenifer GoodwinHealthDay ReporterWEDNESDAY, Jan. 5 (HealthDay News) -- A two-week course of an antibiotic relieved bloating and other symptoms of irritable bowel syndrome, a common gastrointestinal disorder, for more than two months after treatment ended, new research shows.Researchers say the antibiotic, rifaximin, made by Salix Pharmaceuticals, is the first treatment for irritable bowel syndrome that gets at the underlying cause of the condition, rather than just treating the symptoms.The findings are published in the Jan. 6 issue of the New England Journal of Medicine.Article Link: http://health.usnews.com/health-news/diet-fitness/digestive-disorders/articles/2011/01/05/antibiotic-may-help-ease-irritable-bowel.html


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