Rifaximin therapy for patients with irritable bowel syndrome without constipation.
Identifieur interne : 001596 ( Main/Corpus ); précédent : 001595; suivant : 001597Rifaximin therapy for patients with irritable bowel syndrome without constipation.
Auteurs : Mark Pimentel ; Anthony Lembo ; William D. Chey ; Salam Zakko ; Yehuda Ringel ; Jing Yu ; Shadreck M. Mareya ; Audrey L. Shaw ; Enoch Bortey ; William P. ForbesSource :
- The New England journal of medicine [ 1533-4406 ] ; 2011.
English descriptors
- KwdEn :
- Abdominal Pain (drug therapy), Abdominal Pain (etiology), Aged (MeSH), Anti-Bacterial Agents (adverse effects), Anti-Bacterial Agents (therapeutic use), Diarrhea (drug therapy), Diarrhea (etiology), Double-Blind Method (MeSH), Female (MeSH), Humans (MeSH), Irritable Bowel Syndrome (complications), Irritable Bowel Syndrome (drug therapy), Male (MeSH), Middle Aged (MeSH), Rifamycins (adverse effects), Rifamycins (therapeutic use), Rifaximin (MeSH).
- MESH :
- chemical , adverse effects : Anti-Bacterial Agents, Rifamycins.
- complications : Irritable Bowel Syndrome.
- drug therapy : Abdominal Pain, Diarrhea, Irritable Bowel Syndrome.
- etiology : Abdominal Pain, Diarrhea.
- chemical , therapeutic use : Anti-Bacterial Agents, Rifamycins.
- Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Rifaximin.
Abstract
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.).
DOI: 10.1056/NEJMoa1004409
PubMed: 21208106
Links to Exploration step
pubmed:21208106Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Rifaximin therapy for patients with irritable bowel syndrome without constipation.</title><author><name sortKey="Pimentel, Mark" sort="Pimentel, Mark" uniqKey="Pimentel M" first="Mark" last="Pimentel">Mark Pimentel</name><affiliation><nlm:affiliation>Cedars-Sinai Medical Center, Los Angeles, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lembo, Anthony" sort="Lembo, Anthony" uniqKey="Lembo A" first="Anthony" last="Lembo">Anthony Lembo</name></author><author><name sortKey="Chey, William D" sort="Chey, William D" uniqKey="Chey W" first="William D" last="Chey">William D. Chey</name></author><author><name sortKey="Zakko, Salam" sort="Zakko, Salam" uniqKey="Zakko S" first="Salam" last="Zakko">Salam Zakko</name></author><author><name sortKey="Ringel, Yehuda" sort="Ringel, Yehuda" uniqKey="Ringel Y" first="Yehuda" last="Ringel">Yehuda Ringel</name></author><author><name sortKey="Yu, Jing" sort="Yu, Jing" uniqKey="Yu J" first="Jing" last="Yu">Jing Yu</name></author><author><name sortKey="Mareya, Shadreck M" sort="Mareya, Shadreck M" uniqKey="Mareya S" first="Shadreck M" last="Mareya">Shadreck M. Mareya</name></author><author><name sortKey="Shaw, Audrey L" sort="Shaw, Audrey L" uniqKey="Shaw A" first="Audrey L" last="Shaw">Audrey L. Shaw</name></author><author><name sortKey="Bortey, Enoch" sort="Bortey, Enoch" uniqKey="Bortey E" first="Enoch" last="Bortey">Enoch Bortey</name></author><author><name sortKey="Forbes, William P" sort="Forbes, William P" uniqKey="Forbes W" first="William P" last="Forbes">William P. Forbes</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2011">2011</date><idno type="RBID">pubmed:21208106</idno><idno type="pmid">21208106</idno><idno type="doi">10.1056/NEJMoa1004409</idno><idno type="wicri:Area/Main/Corpus">001596</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001596</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Rifaximin therapy for patients with irritable bowel syndrome without constipation.</title><author><name sortKey="Pimentel, Mark" sort="Pimentel, Mark" uniqKey="Pimentel M" first="Mark" last="Pimentel">Mark Pimentel</name><affiliation><nlm:affiliation>Cedars-Sinai Medical Center, Los Angeles, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lembo, Anthony" sort="Lembo, Anthony" uniqKey="Lembo A" first="Anthony" last="Lembo">Anthony Lembo</name></author><author><name sortKey="Chey, William D" sort="Chey, William D" uniqKey="Chey W" first="William D" last="Chey">William D. Chey</name></author><author><name sortKey="Zakko, Salam" sort="Zakko, Salam" uniqKey="Zakko S" first="Salam" last="Zakko">Salam Zakko</name></author><author><name sortKey="Ringel, Yehuda" sort="Ringel, Yehuda" uniqKey="Ringel Y" first="Yehuda" last="Ringel">Yehuda Ringel</name></author><author><name sortKey="Yu, Jing" sort="Yu, Jing" uniqKey="Yu J" first="Jing" last="Yu">Jing Yu</name></author><author><name sortKey="Mareya, Shadreck M" sort="Mareya, Shadreck M" uniqKey="Mareya S" first="Shadreck M" last="Mareya">Shadreck M. Mareya</name></author><author><name sortKey="Shaw, Audrey L" sort="Shaw, Audrey L" uniqKey="Shaw A" first="Audrey L" last="Shaw">Audrey L. Shaw</name></author><author><name sortKey="Bortey, Enoch" sort="Bortey, Enoch" uniqKey="Bortey E" first="Enoch" last="Bortey">Enoch Bortey</name></author><author><name sortKey="Forbes, William P" sort="Forbes, William P" uniqKey="Forbes W" first="William P" last="Forbes">William P. Forbes</name></author></analytic><series><title level="j">The New England journal of medicine</title><idno type="eISSN">1533-4406</idno><imprint><date when="2011" type="published">2011</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abdominal Pain (drug therapy)</term><term>Abdominal Pain (etiology)</term><term>Aged (MeSH)</term><term>Anti-Bacterial Agents (adverse effects)</term><term>Anti-Bacterial Agents (therapeutic use)</term><term>Diarrhea (drug therapy)</term><term>Diarrhea (etiology)</term><term>Double-Blind Method (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Irritable Bowel Syndrome (complications)</term><term>Irritable Bowel Syndrome (drug therapy)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Rifamycins (adverse effects)</term><term>Rifamycins (therapeutic use)</term><term>Rifaximin (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Rifamycins</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Irritable Bowel Syndrome</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Abdominal Pain</term><term>Diarrhea</term><term>Irritable Bowel Syndrome</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Abdominal Pain</term><term>Diarrhea</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Rifamycins</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Rifaximin</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>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.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>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.).</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21208106</PMID><DateCompleted><Year>2011</Year><Month>01</Month><Day>12</Day></DateCompleted><DateRevised><Year>2018</Year><Month>12</Month><Day>01</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1533-4406</ISSN><JournalIssue CitedMedium="Internet"><Volume>364</Volume><Issue>1</Issue><PubDate><Year>2011</Year><Month>Jan</Month><Day>06</Day></PubDate></JournalIssue><Title>The New England journal of medicine</Title><ISOAbbreviation>N Engl J Med</ISOAbbreviation></Journal><ArticleTitle>Rifaximin therapy for patients with irritable bowel syndrome without constipation.</ArticleTitle><Pagination><MedlinePgn>22-32</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1056/NEJMoa1004409</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">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.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">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.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">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.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">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.).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pimentel</LastName><ForeName>Mark</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Cedars-Sinai Medical Center, Los Angeles, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lembo</LastName><ForeName>Anthony</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Chey</LastName><ForeName>William D</ForeName><Initials>WD</Initials></Author><Author ValidYN="Y"><LastName>Zakko</LastName><ForeName>Salam</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Ringel</LastName><ForeName>Yehuda</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Yu</LastName><ForeName>Jing</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Mareya</LastName><ForeName>Shadreck M</ForeName><Initials>SM</Initials></Author><Author ValidYN="Y"><LastName>Shaw</LastName><ForeName>Audrey L</ForeName><Initials>AL</Initials></Author><Author ValidYN="Y"><LastName>Bortey</LastName><ForeName>Enoch</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Forbes</LastName><ForeName>William P</ForeName><Initials>WP</Initials></Author><Author ValidYN="Y"><CollectiveName>TARGET Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00724126</AccessionNumber><AccessionNumber>NCT00731679</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>N Engl J Med</MedlineTA><NlmUniqueID>0255562</NlmUniqueID><ISSNLinking>0028-4793</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000900">Anti-Bacterial Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D012294">Rifamycins</NameOfSubstance></Chemical><Chemical><RegistryNumber>L36O5T016N</RegistryNumber><NameOfSubstance UI="D000078262">Rifaximin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>N Engl J Med. 2011 Jan 6;364(1):81-2</RefSource><PMID Version="1">21208112</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>N Engl J Med. 2011 Apr 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Aug;5(4):461-4</RefSource><PMID Version="1">21780893</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Curr Gastroenterol Rep. 2011 Oct;13(5):398-401</RefSource><PMID Version="1">21800072</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D015746" MajorTopicYN="N">Abdominal Pain</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000900" MajorTopicYN="N">Anti-Bacterial Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003967" MajorTopicYN="N">Diarrhea</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D043183" MajorTopicYN="N">Irritable Bowel Syndrome</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012294" MajorTopicYN="N">Rifamycins</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000078262" MajorTopicYN="N">Rifaximin</DescriptorName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Alexander</LastName><ForeName>M</ForeName><Initials>M</Initials></Investigator><Investigator ValidYN="Y"><LastName>Alwine</LastName><ForeName>L</ForeName><Initials>L</Initials></Investigator><Investigator ValidYN="Y"><LastName>Anspach</LastName><ForeName>R</ForeName><Initials>R</Initials></Investigator><Investigator ValidYN="Y"><LastName>Armstrong</LastName><ForeName>D</ForeName><Initials>D</Initials></Investigator><Investigator ValidYN="Y"><LastName>Ashby</LastName><ForeName>K</ForeName><Initials>K</Initials></Investigator><Investigator ValidYN="Y"><LastName>Banker</LastName><ForeName>L</ForeName><Initials>L</Initials></Investigator><Investigator 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