# Rifaximin Helps in the Treatment of Irritable Bowel Syndrome: Presented at ACG



## Jeffrey Roberts

"Rifaximin Helps in the Treatment of Irritable Bowel Syndrome: Presented at ACG"By Paula Moyer HONOLULU, HI -- November 2, 2005 -- Patients with irritable bowel syndrome (IBS) often get relief from one 10-day course of rifaximin (Xifaxan), according to investigators who presented their findings here November 1[st at the 70th annual meeting of the American College of Gastroenterology (ACG). Rifaximin is currently approved for the treatment of traveler's diarrhea but is often used off-label to treat IBS. The current research was designed to see whether the treatment is effective in the IBS setting."This is the first treatment I've seen for IBS with which the benefit is sustained when the treatment is stopped," said principal investigator Mark Pimentel, MD, Director, GI Motility Program, Cedars-Sinai Medical Center, Los Angeles. "Typically when you stop the treatment, you're right back to baseline."Dr. Pimentel and colleagues randomized 87 patients who met Rome I criteria for IBS to receive either placebo or 400 mg of rifaximin orally three times daily for 10 days. During the treatment phase and for 7 days after treatment ended, subjects completed a stool diary and responded to a symptom questionnaire and lactulose breath test. Subjects and investigators were blinded to the test results.The 43 patients in the rifaximin group had an average overall symptom improvement of 37.7%, compared to compared to 23.4% of the 44 placebo patients (P < .05). In treatment group, 37% of participants were classified as clinical responders, compared to 16% of those in the placebo group. The study defined response as at least a 50% overall improvement.Subjects with diarrhea were more likely than those with constipation to respond to treatment with rifaximin, Dr. Pimentel said. The clinical response among those with diarrhea was 49% for those on rifaximin compared to 23% of those on placebo (P < .05). Bloating was also improved, but not in a statistically significant manner, and the investigators documented no difference in patients with constipation.The study was funded by Salix Pharmaceuticals, Ltd., which manufactures Xifaxan.[Presentation title: Rifaximin, a Non-Absorbable Antibiotic Improves the Symptoms of Irritable Bowel Syndrome: a Double-Blind Randomized Controlled Study. Abstract 42]


----------



## Jeffrey Roberts

October 31, 2005 03:08 PM US Eastern Timezone Salix Pharmaceuticals Reports American College of Gastroenterology XIFAXAN® Update; XIFAXAN® Studied in Six Investigator-Initiated Trials BIOWIRE2K RALEIGH, N.C.--(BUSINESS WIRE)--Oct. 31, 2005--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that results of six investigator-initiated trials of XIFAXAN® (rifaximin) will be presented at the American College of Gastroenterology 2005 Annual Scientific Meeting. Study investigators will present their findings during the ACG meeting which is being held October 28 - November 2 in Honolulu, HI. "The presentations this week at ACG are an indication of researchers' and clinicians' interest in and the potential of XIFAXAN, a nonsystemic, gastrointestinal-selective, oral antibiotic to potentially address the bacterial component of a wide variety of gastrointestinal medical needs - including irritable bowel syndrome, hepatic encephalopathy and inflammatory bowel disease," stated Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer, Salix. "The findings of these exploratory trials add to our expanding body of knowledge that we are utilizing to prioritize and design programs to develop XIFAXAN as a therapeutic option in a number of GI diseases. We intend to initiate trials in a number of these areas in the coming months." Irritable Bowel Syndrome Dr. Mark Pimentel, Cedars-Sinai Medical Center, Los Angeles, CA, et al. investigated the efficacy of XIFAXAN in improving the global symptoms of subjects with irritable bowel syndrome (IBS) meeting the Rome I criteria. Eighty-seven subjects received either XIFAXAN 1200 mg daily (400 mg TID) or placebo for 10 days in this randomized, double-blind, two-center study. Subjects completed a symptom questionnaire and a lactulose breath test (LBT) for seven days prior to and seven days following therapy. The study enrolled a broad spectrum of IBS subjects, enrolling subjects regardless of either their baseline LBT (LBT positive and negative) or their chief IBS complaint (diarrhea, constipation and alternators). The intention-to-treat analysis revealed a statistically significant improvement in subjects receiving XIFAXAN versus placebo-treated subjects (38% vs. 23% in global improvement; p less than 0.05). Thirty-seven percent of XIFAXAN-treated subjects demonstrated a greater than 50% global improvement, compared to 16% of placebo recipients (p less than 0.05). In subgroup analyses, subjects enrolled with diarrhea demonstrated a global improvement of 49% with XIFAXAN vs. 23% of placebo recipients (p less than 0.05). Bloating was improved in subjects that received XIFAXAN. Numerical, but not statistical, differences were seen between the two treatment groups in subjects presenting with constipation, although the numbers were too small to make any inference about efficacy in this subgroup from this trial. Results of the methane breath test demonstrated that methane was almost exclusively associated with constipation and that the degree of methane production correlated significantly with constipation severity, stool frequency and Bristol stool score. Dr. Pimentel's study has been selected for oral presentation on Tuesday, November 1.


----------



## 19102

Jeff or anyone: Has anyone on the Board been prescribed with Rifaximin, and if so with what results> Bill


----------



## Jeffrey Roberts

http://www.newswise.com/p/articles/view/515982/Source: Cedars-Sinai Medical CenterReleased: Tue 08-Nov-2005, 14:00 ET Targeted Antibiotics Lead to Long-Lasting Improvement in IBS SymptomsNewswise â€" Researchers at Cedars-Sinai Medical Center have found that a nonabsorbable antibiotic â€" one that stays in the gut â€" may be an effective long-term treatment for irritable bowel syndrome (IBS), a disease affecting more than an estimated 20 percent of Americans. The findings, which showed that participants benefited from the antibiotic use even after the course of treatment ended, support previously published research identifying small intestine bacterial overgrowth (SIBO) as a possible cause of the disease. The research was presented at the recent American College of Gastroenterologyâ€™s annual meeting in Honolulu, HI. â€œThis study is important as it is the first to show that the use of targeted antibiotics results in a more significant and long-lasting improvement in IBS symptoms,â€ said Mark Pimentel, M.D., first author on the study and director of the GI Motility Program at Cedars-Sinai. â€œThese results clearly show that antibiotics offer a new treatment approach â€" and a new hope â€" for people with IBS.â€ The randomized, double blind study involved 87 patients. Those on the rifaximin experienced a 37 percent overall improvement of their IBS symptoms as compared to 23 percent on the placebo. Among study subjects whose primary symptom was diarrhea, those on the antibiotic showed more than twice the improvement of those on the placebo (49 percent vs. 23 percent). Patients received the drug (or placebo) for 10 days and were then followed for a total of 10 weeks. Participants kept a stool diary, took a questionnaire and were given methane breath tests. The positive effects of the drug were shown to continue throughout most of the 10-week study, not just during the actual antibiotic course. Because the cause of IBS has been elusive, treatments for the disease have historically focused on reducing its symptoms â€" diarrhea and constipation â€" by giving medications that either slow or speed up the digestive process. In 2000, Pimentel linked bloating, the most common symptom of IBS, to bacterial fermentation, showing that small intestine bacteria overgrowth (SIBO) may be the causative factor in IBS (The American Journal of Gastroenterology, Dec. 2000). To show evidence of small intestine bacterial overgrowth, participants in both studies were given a lactulose breath test, which monitors the level of hydrogen and methane (the gases emitted by fermented bacteria) on the breath. In the first study, an abnormal breath methane profile was shown to be 100 percent predictive of constipation-predominant IBS. In the current study, the correlation between the amount of methane and the amount of constipation was confirmed, another key finding.â€œWe were pleased â€" but not surprised â€" with the results of this study,â€ said Pimentel. â€œThe next step is to start larger, multi-centered studies to confirm the positive results of this study, which suggest that people can benefit from targeted antibiotic treatment for their IBS.â€ Irritable Bowel Syndrome is an intestinal disorder that causes abdominal pain or discomfort, cramping or bloating and diarrhea and constipation. It is a long-term condition that usually begins in adolescence or in early adult life. Episodes may be mild or severe and may be exacerbated by stress. It is one of the top ten most frequently diagnosed conditions among U.S. physicians and affects women more often than men. Other authors from Cedars-Sinai include Sandy Park, B.A., Yuthana Kong M.P.H. and Robert Wade. Sunanda V. Kane from the University of Chicago also participated in the study. Rifaximin is made by Salix Pharmaceuticals, Inc. Funding for the study was provided by Salix Pharmaceuticals, Inc.One of only five hospitals in California whose nurses have been honored with the prestigious Magnet designation, Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 17 consecutive years, it has been named Los Angelesâ€™ most preferred hospital for all health needs in an independent survey of area residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities and was recently fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Additional information is available at http://www.cedars-sinai.edu.--------------------------------------------------------------------------------Â© 2005 Newswise. All Rights Reserved


----------



## Jeffrey Roberts

Bill,I don't have an answer for you about that. As you can imagine, there is much controversy about this treatment so I doubt it has been widely accepted as of yet.We have invited Dr. Pimentel to speak to us in a chat session. Stay tuned for details.Jeff


----------



## eric

Several GI Disorders May Respond to RifaximinPaula Moyer, MA Nov. 2, 2005 (Honolulu) â€" Several gastrointestinal disorders beyond traveler's diarrhea respond to rifaximin (Xifaxan), according to investigators who presented their findings here at the 70th annual meeting of the American College of Gastroenterology.Patients with irritable bowel syndrome (IBS) often get relief from one 10-day course of rifaximin (Xifaxan), according to principal investigator Mark Pimentel, MD. And in other research investigators found that patients with hepatic encephalopathy who take rifaximin have fewer, shorter hospitalizations and less severe disease.Rifaximin is currently approved for the treatment of traveler's diarrhea. It is an oral antibiotic that is treated to resist absorption until it passes to the colon."This is the first treatment I've seen for IBS with which the benefit is sustained when the treatment is stopped," Dr. Pimentel told Medscape. He is the director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles, California. "To me, this means that we're onto something." He pointed out that some IBS experts think that one underlying cause may be an overgrowth of bacteria, and that this development may explain why an antibiotic would resolve the condition.Dr. Pimentel and coinvestigators recruited 91 patients with IBS to participate in a trial comparing rifaximin to placebo. The patients met the Rome I criteria for IBS. For seven days, the patients kept a stool diary and also responded to a questionnaire and a lactulose breath test, with the results blinded to both subjects and investigators.The investigators then randomized 87 patients to receive either placebo (n = 44) or rifaximin (n = 43) for 10 days. The patients in the treatment group received 400 mg of rifaximin orally three times daily for 10 days. For seven days after treatment ended, subjects repeated the stool diary and then responded to a symptom questionnaire and lactulose breath test.Patients in the rifaximin group had an average overall symptom improvement of 37.7% compared with 23.4% for patients in the placebo group (P < .05). In the treatment group, 37% of the participants were classified as clinical responders compared with 16% of those in the placebo group. The study design defined responders as those who had at least a 50% overall improvement.Subjects with diarrhea were the most likely to respond to treatment, Dr. Pimentel said. With neomycin, the response is more often seen in patients whose predominant symptom is constipation. The clinical response rate among those with diarrhea was 49% for those receiving rifaximin compared with 23% of those receiving placebo (P < .05). Bloating was also improved, but not in a statistically significant manner, and the investigators documented no difference in patients with constipation.The shift to antibiotic therapy is an important direction for physicians to watch, said Patricia Raymond, MD, in an interview seeking outside comment. She is an associate professor of clinical internal medicine at Eastern Virginia Medical School in Norfolk."What's come to light this year [at the annual meeting] is that a subset of IBS patients may suffer from bacterial overgrowth in the small intestine," Dr. Raymond said. "The notion that some IBS patients will respond to an antibiotic opens up the whole question: what is IBS? We have those with diarrhea, those with constipation, and those who flip between. But we always had those we couldn't treat. Now we have one more avenue, one more possible treatment. It's one more thing to do â€" not the first thing, but it's one more thing to do after ruling out other conditions with similar symptoms."In other research, Carroll Leevy, MD, and colleagues found that patients with hepatic encephalopathy had a stronger response to rifaximin than to lactulose. Dr. Leevy is an associate professor of medicine at the New Jersey Medical School Liver Center in Newark, where he is the associate director for clinical affairs at the Sammy Davis, Jr., National Liver Institute.In a crossover, retrospective chart review involving 145 patients, the patients initially received lactulose at a dose of 30 cc twice daily for at least six months and then rifaximin at a dose of 400 mg three times daily for at least six months. The investigators then evaluated the patients' responses to the last six months of lactulose compared with the first six months of rifaximin.During the rifaximin treatment period, patients were hospitalized an average of 0.5 times compared with an average of 1.6 times during the lactulose treatment period (P < .001). The hospitalizations during the rifaximin period were an average of 3.14 days compared with an average of 12.52 days in the lactulose period (P < .001). In addition, the hepatic encephalopathy grade was lower in the rifaximin period, and fewer patients had asterixis, a tremor associated with advanced liver disease. Patients also reported less diarrhea, flatulence, and abdominal pain while receiving rifaximin (P < .001 for all). Patients were also more likely to comply with medication while receiving rifaximin, Dr. Leevy said (P < .001). The Healthcare Cost Utilization Project (HCUP) data showed that rifaximin was associated with a cost savings of $67,559 per patient, he said.The studies were funded by Salix Pharmaceuticals, Ltd., which manufactures Xifaxan.ACG 70th Annual Meeting: Abstracts 42 and 44. Presented Nov. 1, 2005.Reviewed by Gary D. Vogin, MD


----------



## 14397

Are GI Docs prescribing this for IBS-D? Is this approved and when can I try this, what is the status of this drug?


----------



## 14397

what's going on with this med, is anyone get prescribed it and is it hard to get? Anyone had any success with it?


----------



## Kathleen M.

It isn't so much to treat IBS-D, but to treat people that have SIBO (small intestinal bacterial overgrowth). It is an approved antibiotic and SIBO would be one of the things it is used for as that has to do with bacteria. If you notice in the article they discuss the lactulose breath test which is used to confirm SIBO.You really should get tested for SIBO before taking this drug or other antibiotic randomly to see if it helps.One reason is the first antibiotic they give you might not be the right one for you and if you haven't been tested you don't know if it didn't work because you didn't have SIBO, or it just wasn't the right antibiotic. A fair number of people getting antibiotics just in case they help are not getting help, but they were never tested for SIBO so we don't know if there would be any reason for them to help.Unfortunately not everyone has access to a place that tests for SIBO. So you get a lot of IBSers that get antibiotics blindly.K.


----------



## 19927

I took it for fourteen days this summer, when Pimental and Rifaximin were really hot topics here. It didn't do anything for me. Several others took it as well, and i still see them all posting here in search of cures, so i don't think it worked for them either. There are thousand, perhaps tens of thousands of ibs sufferers who post and read the posts here. If Rifaximin was really something that could cure a lot of us, there would be a lot of success stories on this board. Sorry to be negative.


----------



## 14397

Thanks Wormout for the feedback, great to know. I just wish there was something that would stabilize my stomach and help with the D and problems with food and other things. I wish they Cilansetron would be approved. thanks again


----------



## Guest

Itired it and had no luck w/ symptoms of IBS-C. Has anyone had luck w/ Digestrol for IBS-C


----------



## 17176

hello & welcome mary


----------



## SteveE

Wow. Wornout's comments bum me out. I guess I should've been paying more attention this summer. I only recently read Dr. Pimentel's book and I got really excited. I have an appointment in two weeks with someone who uses the Quintron SC for hydrogen breath testing which I'll still attend, but I guess I'll go to the appointment with tempered enthusiasm. I really had my hopes up, but now I see that I'm probably setting myself up to be severely disappointed again.


----------

