Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy.
Identifieur interne : 001173 ( Main/Corpus ); précédent : 001172; suivant : 001174Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy.
Auteurs : Kevin D. Mullen ; Arun J. Sanyal ; Nathan M. Bass ; Fred F. Poordad ; Muhammad Y. Sheikh ; R Todd Frederick ; Enoch Bortey ; William P. ForbesSource :
- Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [ 1542-7714 ] ; 2014.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Aged, 80 and over (MeSH), Drug-Related Side Effects and Adverse Reactions (epidemiology), Female (MeSH), Gastrointestinal Agents (adverse effects), Gastrointestinal Agents (therapeutic use), Hepatic Encephalopathy (drug therapy), Hospitalization (statistics & numerical data), Humans (MeSH), Longitudinal Studies (MeSH), Male (MeSH), Middle Aged (MeSH), Placebos (administration & dosage), Rifamycins (adverse effects), Rifamycins (therapeutic use), Rifaximin (MeSH), Young Adult (MeSH).
- MESH :
- chemical , administration & dosage : Placebos.
- chemical , adverse effects : Gastrointestinal Agents, Rifamycins.
- drug therapy : Hepatic Encephalopathy.
- epidemiology : Drug-Related Side Effects and Adverse Reactions.
- statistics & numerical data : Hospitalization.
- chemical , therapeutic use : Gastrointestinal Agents, Rifamycins.
- Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Longitudinal Studies, Male, Middle Aged, Rifaximin, Young Adult.
Abstract
BACKGROUND & AIMS
Rifaximin is a gut-selective, oral antimicrobial agent shown to reduce the recurrence of overt hepatic encephalopathy (HE) and HE-related hospitalizations in a 6-month, randomized, controlled trial (RCT). We performed a phase 3, open-label maintenance study to assess the safety and rate of hospitalization with long-term rifaximin use.
METHODS
We conducted a 24-month, open-label maintenance study of rifaximin (550 mg, twice daily) in patients with HE who participated in the previous RCT of rifaximin or new patients enrolled from March 2007 to December 2010. Safety was assessed (adverse events, clinical laboratory parameters) for the integrated population of all patients, who were given rifaximin 550 mg twice daily (all-rifaximin population, N = 392). Safety and hospitalization data were compared between the group given placebo in the original RCT (n = 159) and those given rifaximin (n = 140).
RESULTS
In the all-rifaximin population, the median exposure to rifaximin was 427.0 days (range, 2-1427 d), with 510.5 person-years of exposure. The profile and rate of adverse events with long-term rifaximin treatment were similar to those of the original RCT. There was no increase in the rate of infections, including with Clostridium difficile, or development of bacterial antibiotic resistance. Rates of hospitalizations with long-term rifaximin administration remained low: the HE-related hospitalization rate, normalized for exposure (0.21; all-rifaximin population), was similar to that of the rifaximin group in the original RCT (0.30), and lower than that for the placebo group (0.72).
CONCLUSIONS
Long-term treatment (≥24 mo) with rifaximin (550 mg, twice daily) appears to provide a continued reduction in the rate of HE-related and all-cause hospitalization, without an increased rate of adverse events. ClinicalTrials.gov number: NCT00686920.
DOI: 10.1016/j.cgh.2013.12.021
PubMed: 24365449
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pubmed:24365449Le document en format XML
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Bass</name><affiliation><nlm:affiliation>Divison of Gastroenterology, University of California San Francisco, San Francisco, California.</nlm:affiliation></affiliation></author><author><name sortKey="Poordad, Fred F" sort="Poordad, Fred F" uniqKey="Poordad F" first="Fred F" last="Poordad">Fred F. Poordad</name><affiliation><nlm:affiliation>The Texas Liver Institute/University of Texas Health Science Center, San Antonio, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Sheikh, Muhammad Y" sort="Sheikh, Muhammad Y" uniqKey="Sheikh M" first="Muhammad Y" last="Sheikh">Muhammad Y. Sheikh</name><affiliation><nlm:affiliation>University of California San Francisco Fresno Medical Education Program, Fresno, California.</nlm:affiliation></affiliation></author><author><name sortKey="Frederick, R Todd" sort="Frederick, R Todd" uniqKey="Frederick R" first="R Todd" last="Frederick">R Todd Frederick</name><affiliation><nlm:affiliation>Division of Hepatology, California Pacific Medical Center, San Francisco, California.</nlm:affiliation></affiliation></author><author><name sortKey="Bortey, Enoch" sort="Bortey, Enoch" uniqKey="Bortey E" first="Enoch" last="Bortey">Enoch Bortey</name><affiliation><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation></affiliation></author><author><name sortKey="Forbes, William P" sort="Forbes, William P" uniqKey="Forbes W" first="William P" last="Forbes">William P. Forbes</name><affiliation><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24365449</idno><idno type="pmid">24365449</idno><idno type="doi">10.1016/j.cgh.2013.12.021</idno><idno type="wicri:Area/Main/Corpus">001173</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001173</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy.</title><author><name sortKey="Mullen, Kevin D" sort="Mullen, Kevin D" uniqKey="Mullen K" first="Kevin D" last="Mullen">Kevin D. Mullen</name><affiliation><nlm:affiliation>Case Western Reserve University School of Medicine, Cleveland, Ohio. Electronic address: kdm@case.edu.</nlm:affiliation></affiliation></author><author><name sortKey="Sanyal, Arun J" sort="Sanyal, Arun J" uniqKey="Sanyal A" first="Arun J" last="Sanyal">Arun J. Sanyal</name><affiliation><nlm:affiliation>Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond, Virginia.</nlm:affiliation></affiliation></author><author><name sortKey="Bass, Nathan M" sort="Bass, Nathan M" uniqKey="Bass N" first="Nathan M" last="Bass">Nathan M. Bass</name><affiliation><nlm:affiliation>Divison of Gastroenterology, University of California San Francisco, San Francisco, California.</nlm:affiliation></affiliation></author><author><name sortKey="Poordad, Fred F" sort="Poordad, Fred F" uniqKey="Poordad F" first="Fred F" last="Poordad">Fred F. Poordad</name><affiliation><nlm:affiliation>The Texas Liver Institute/University of Texas Health Science Center, San Antonio, Texas.</nlm:affiliation></affiliation></author><author><name sortKey="Sheikh, Muhammad Y" sort="Sheikh, Muhammad Y" uniqKey="Sheikh M" first="Muhammad Y" last="Sheikh">Muhammad Y. Sheikh</name><affiliation><nlm:affiliation>University of California San Francisco Fresno Medical Education Program, Fresno, California.</nlm:affiliation></affiliation></author><author><name sortKey="Frederick, R Todd" sort="Frederick, R Todd" uniqKey="Frederick R" first="R Todd" last="Frederick">R Todd Frederick</name><affiliation><nlm:affiliation>Division of Hepatology, California Pacific Medical Center, San Francisco, California.</nlm:affiliation></affiliation></author><author><name sortKey="Bortey, Enoch" sort="Bortey, Enoch" uniqKey="Bortey E" first="Enoch" last="Bortey">Enoch Bortey</name><affiliation><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation></affiliation></author><author><name sortKey="Forbes, William P" sort="Forbes, William P" uniqKey="Forbes W" first="William P" last="Forbes">William P. Forbes</name><affiliation><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association</title><idno type="eISSN">1542-7714</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Aged (MeSH)</term><term>Aged, 80 and over (MeSH)</term><term>Drug-Related Side Effects and Adverse Reactions (epidemiology)</term><term>Female (MeSH)</term><term>Gastrointestinal Agents (adverse effects)</term><term>Gastrointestinal Agents (therapeutic use)</term><term>Hepatic Encephalopathy (drug therapy)</term><term>Hospitalization (statistics & numerical data)</term><term>Humans (MeSH)</term><term>Longitudinal Studies (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Placebos (administration & dosage)</term><term>Rifamycins (adverse effects)</term><term>Rifamycins (therapeutic use)</term><term>Rifaximin (MeSH)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Placebos</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Gastrointestinal Agents</term><term>Rifamycins</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Hepatic Encephalopathy</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Hospitalization</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Gastrointestinal Agents</term><term>Rifamycins</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Rifaximin</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND & AIMS</b></p><p>Rifaximin is a gut-selective, oral antimicrobial agent shown to reduce the recurrence of overt hepatic encephalopathy (HE) and HE-related hospitalizations in a 6-month, randomized, controlled trial (RCT). We performed a phase 3, open-label maintenance study to assess the safety and rate of hospitalization with long-term rifaximin use.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We conducted a 24-month, open-label maintenance study of rifaximin (550 mg, twice daily) in patients with HE who participated in the previous RCT of rifaximin or new patients enrolled from March 2007 to December 2010. Safety was assessed (adverse events, clinical laboratory parameters) for the integrated population of all patients, who were given rifaximin 550 mg twice daily (all-rifaximin population, N = 392). Safety and hospitalization data were compared between the group given placebo in the original RCT (n = 159) and those given rifaximin (n = 140).</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>In the all-rifaximin population, the median exposure to rifaximin was 427.0 days (range, 2-1427 d), with 510.5 person-years of exposure. The profile and rate of adverse events with long-term rifaximin treatment were similar to those of the original RCT. There was no increase in the rate of infections, including with Clostridium difficile, or development of bacterial antibiotic resistance. Rates of hospitalizations with long-term rifaximin administration remained low: the HE-related hospitalization rate, normalized for exposure (0.21; all-rifaximin population), was similar to that of the rifaximin group in the original RCT (0.30), and lower than that for the placebo group (0.72).</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Long-term treatment (≥24 mo) with rifaximin (550 mg, twice daily) appears to provide a continued reduction in the rate of HE-related and all-cause hospitalization, without an increased rate of adverse events. ClinicalTrials.gov number: NCT00686920.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24365449</PMID><DateCompleted><Year>2015</Year><Month>03</Month><Day>12</Day></DateCompleted><DateRevised><Year>2018</Year><Month>12</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1542-7714</ISSN><JournalIssue CitedMedium="Internet"><Volume>12</Volume><Issue>8</Issue><PubDate><Year>2014</Year><Month>Aug</Month></PubDate></JournalIssue><Title>Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association</Title><ISOAbbreviation>Clin Gastroenterol Hepatol</ISOAbbreviation></Journal><ArticleTitle>Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy.</ArticleTitle><Pagination><MedlinePgn>1390-7.e2</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.cgh.2013.12.021</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1542-3565(13)01968-X</ELocationID><Abstract><AbstractText Label="BACKGROUND & AIMS" NlmCategory="OBJECTIVE">Rifaximin is a gut-selective, oral antimicrobial agent shown to reduce the recurrence of overt hepatic encephalopathy (HE) and HE-related hospitalizations in a 6-month, randomized, controlled trial (RCT). We performed a phase 3, open-label maintenance study to assess the safety and rate of hospitalization with long-term rifaximin use.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We conducted a 24-month, open-label maintenance study of rifaximin (550 mg, twice daily) in patients with HE who participated in the previous RCT of rifaximin or new patients enrolled from March 2007 to December 2010. Safety was assessed (adverse events, clinical laboratory parameters) for the integrated population of all patients, who were given rifaximin 550 mg twice daily (all-rifaximin population, N = 392). Safety and hospitalization data were compared between the group given placebo in the original RCT (n = 159) and those given rifaximin (n = 140).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">In the all-rifaximin population, the median exposure to rifaximin was 427.0 days (range, 2-1427 d), with 510.5 person-years of exposure. The profile and rate of adverse events with long-term rifaximin treatment were similar to those of the original RCT. There was no increase in the rate of infections, including with Clostridium difficile, or development of bacterial antibiotic resistance. Rates of hospitalizations with long-term rifaximin administration remained low: the HE-related hospitalization rate, normalized for exposure (0.21; all-rifaximin population), was similar to that of the rifaximin group in the original RCT (0.30), and lower than that for the placebo group (0.72).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Long-term treatment (≥24 mo) with rifaximin (550 mg, twice daily) appears to provide a continued reduction in the rate of HE-related and all-cause hospitalization, without an increased rate of adverse events. ClinicalTrials.gov number: NCT00686920.</AbstractText><CopyrightInformation>Copyright © 2014 AGA Institute. Published by Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Mullen</LastName><ForeName>Kevin D</ForeName><Initials>KD</Initials><AffiliationInfo><Affiliation>Case Western Reserve University School of Medicine, Cleveland, Ohio. Electronic address: kdm@case.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sanyal</LastName><ForeName>Arun J</ForeName><Initials>AJ</Initials><AffiliationInfo><Affiliation>Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond, Virginia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bass</LastName><ForeName>Nathan M</ForeName><Initials>NM</Initials><AffiliationInfo><Affiliation>Divison of Gastroenterology, University of California San Francisco, San Francisco, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poordad</LastName><ForeName>Fred F</ForeName><Initials>FF</Initials><AffiliationInfo><Affiliation>The Texas Liver Institute/University of Texas Health Science Center, San Antonio, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sheikh</LastName><ForeName>Muhammad Y</ForeName><Initials>MY</Initials><AffiliationInfo><Affiliation>University of California San Francisco Fresno Medical Education Program, Fresno, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Frederick</LastName><ForeName>R Todd</ForeName><Initials>RT</Initials><AffiliationInfo><Affiliation>Division of Hepatology, California Pacific Medical Center, San Francisco, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bortey</LastName><ForeName>Enoch</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Forbes</LastName><ForeName>William P</ForeName><Initials>WP</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00686920</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>UL1 TR000058</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>12</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Gastroenterol Hepatol</MedlineTA><NlmUniqueID>101160775</NlmUniqueID><ISSNLinking>1542-3565</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005765">Gastrointestinal Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D012294">Rifamycins</NameOfSubstance></Chemical><Chemical><RegistryNumber>L36O5T016N</RegistryNumber><NameOfSubstance UI="D000078262">Rifaximin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Clin Gastroenterol Hepatol. 2014 Oct;12(10):1765</RefSource><PMID Version="1">24703862</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Clin Gastroenterol Hepatol. 2014 Oct;12(10):1765-6</RefSource><PMID Version="1">25008172</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005765" MajorTopicYN="N">Gastrointestinal Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006501" MajorTopicYN="N">Hepatic Encephalopathy</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006760" MajorTopicYN="N">Hospitalization</DescriptorName><QualifierName UI="Q000706" MajorTopicYN="N">statistics & numerical data</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008137" MajorTopicYN="N">Longitudinal Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012294" MajorTopicYN="N">Rifamycins</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000078262" MajorTopicYN="N">Rifaximin</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Antimicrobial Agent</Keyword><Keyword MajorTopicYN="N">Chronic Liver Disease</Keyword><Keyword MajorTopicYN="N">Cirrhosis</Keyword><Keyword MajorTopicYN="N">Xifaxan</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2013</Year><Month>07</Month><Day>22</Day></PubMedPubDate><PubMedPubDate 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