Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial).
Identifieur interne : 000023 ( PubMed/Curation ); précédent : 000022; suivant : 000024Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial).
Auteurs : Rohit Loomba [États-Unis] ; Claude B. Sirlin ; Brandon Ang ; Ricki Bettencourt ; Rashmi Jain ; Joanie Salotti ; Linda Soaft ; Jonathan Hooker ; Yuko Kono ; Archana Bhatt ; Laura Hernandez ; Phirum Nguyen ; Mazen Noureddin ; William Haufe ; Catherine Hooker ; Meng Yin ; Richard Ehman ; Grace Y. Lin ; Mark A. Valasek ; David A. Brenner ; Lisa RichardsSource :
- Hepatology (Baltimore, Md.) ; 2015.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Anticholesteremic Agents, Azetidines.
- drug therapy : Non-alcoholic Fatty Liver Disease.
- Double-Blind Method, Elasticity Imaging Techniques, Ezetimibe, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged.
Abstract
Ezetimibe inhibits intestinal cholesterol absorption and lowers low-density lipoprotein cholesterol. Uncontrolled studies have suggested that it reduces liver fat as estimated by ultrasound in nonalcoholic steatohepatitis (NASH). Therefore, we aimed to examine the efficacy of ezetimibe versus placebo in reducing liver fat by the magnetic resonance imaging-derived proton density-fat fraction (MRI-PDFF) and liver histology in patients with biopsy-proven NASH. In this randomized, double-blind, placebo-controlled trial, 50 patients with biopsy-proven NASH were randomized to either ezetimibe 10 mg orally daily or placebo for 24 weeks. The primary outcome was a change in liver fat as measured by MRI-PDFF in colocalized regions of interest within each of the nine liver segments. Novel assessment by two-dimensional and three-dimensional magnetic resonance elastography was also performed. Ezetimibe was not significantly better than placebo at reducing liver fat as measured by MRI-PDFF (mean difference between the ezetimibe and placebo arms -1.3%, P = 0.4). Compared to baseline, however, end-of-treatment MRI-PDFF was significantly lower in the ezetimibe arm (15%-11.6%, P < 0.016) but not in the placebo arm (18.5%-16.4%, P = 0.15). There were no significant differences in histologic response rates, serum alanine aminotransferase and aspartate aminotransferase levels, or longitudinal changes in two-dimensional and three-dimensional magnetic resonance elastography-derived liver stiffness between the ezetimibe and placebo arms. Compared to histologic nonresponders (25/35), histologic responders (10/35) had a significantly greater reduction in MRI-PDFF (-4.35 ± 4.9% versus -0.30 ± 4.1%, P < 0.019).
DOI: 10.1002/hep.27647
PubMed: 25482832
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Sirlin</name></author><author><name sortKey="Ang, Brandon" sort="Ang, Brandon" uniqKey="Ang B" first="Brandon" last="Ang">Brandon Ang</name></author><author><name sortKey="Bettencourt, Ricki" sort="Bettencourt, Ricki" uniqKey="Bettencourt R" first="Ricki" last="Bettencourt">Ricki Bettencourt</name></author><author><name sortKey="Jain, Rashmi" sort="Jain, Rashmi" uniqKey="Jain R" first="Rashmi" last="Jain">Rashmi Jain</name></author><author><name sortKey="Salotti, Joanie" sort="Salotti, Joanie" uniqKey="Salotti J" first="Joanie" last="Salotti">Joanie Salotti</name></author><author><name sortKey="Soaft, Linda" sort="Soaft, Linda" uniqKey="Soaft L" first="Linda" last="Soaft">Linda Soaft</name></author><author><name sortKey="Hooker, Jonathan" sort="Hooker, Jonathan" uniqKey="Hooker J" first="Jonathan" last="Hooker">Jonathan Hooker</name></author><author><name sortKey="Kono, Yuko" sort="Kono, Yuko" uniqKey="Kono Y" first="Yuko" last="Kono">Yuko Kono</name></author><author><name sortKey="Bhatt, Archana" sort="Bhatt, Archana" uniqKey="Bhatt A" first="Archana" last="Bhatt">Archana Bhatt</name></author><author><name sortKey="Hernandez, Laura" sort="Hernandez, Laura" uniqKey="Hernandez L" first="Laura" last="Hernandez">Laura Hernandez</name></author><author><name sortKey="Nguyen, Phirum" sort="Nguyen, Phirum" uniqKey="Nguyen P" first="Phirum" last="Nguyen">Phirum Nguyen</name></author><author><name sortKey="Noureddin, Mazen" sort="Noureddin, Mazen" uniqKey="Noureddin M" first="Mazen" last="Noureddin">Mazen Noureddin</name></author><author><name sortKey="Haufe, William" sort="Haufe, William" uniqKey="Haufe W" first="William" last="Haufe">William Haufe</name></author><author><name sortKey="Hooker, Catherine" sort="Hooker, Catherine" uniqKey="Hooker C" first="Catherine" last="Hooker">Catherine Hooker</name></author><author><name sortKey="Yin, Meng" sort="Yin, Meng" uniqKey="Yin M" first="Meng" last="Yin">Meng Yin</name></author><author><name sortKey="Ehman, Richard" sort="Ehman, Richard" uniqKey="Ehman R" first="Richard" last="Ehman">Richard Ehman</name></author><author><name sortKey="Lin, Grace Y" sort="Lin, Grace Y" uniqKey="Lin G" first="Grace Y" last="Lin">Grace Y. Lin</name></author><author><name sortKey="Valasek, Mark A" sort="Valasek, Mark A" uniqKey="Valasek M" first="Mark A" last="Valasek">Mark A. Valasek</name></author><author><name sortKey="Brenner, David A" sort="Brenner, David A" uniqKey="Brenner D" first="David A" last="Brenner">David A. Brenner</name></author><author><name sortKey="Richards, Lisa" sort="Richards, Lisa" uniqKey="Richards L" first="Lisa" last="Richards">Lisa Richards</name></author></analytic><series><title level="j">Hepatology (Baltimore, Md.)</title><idno type="e-ISSN">1527-3350</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Anticholesteremic Agents (therapeutic use)</term><term>Azetidines (therapeutic use)</term><term>Double-Blind Method</term><term>Elasticity Imaging Techniques</term><term>Ezetimibe</term><term>Female</term><term>Humans</term><term>Magnetic Resonance Imaging</term><term>Male</term><term>Middle Aged</term><term>Non-alcoholic Fatty Liver Disease (drug therapy)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anticholesteremic Agents</term><term>Azetidines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Non-alcoholic Fatty Liver Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Elasticity Imaging Techniques</term><term>Ezetimibe</term><term>Female</term><term>Humans</term><term>Magnetic Resonance Imaging</term><term>Male</term><term>Middle Aged</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Ezetimibe inhibits intestinal cholesterol absorption and lowers low-density lipoprotein cholesterol. Uncontrolled studies have suggested that it reduces liver fat as estimated by ultrasound in nonalcoholic steatohepatitis (NASH). Therefore, we aimed to examine the efficacy of ezetimibe versus placebo in reducing liver fat by the magnetic resonance imaging-derived proton density-fat fraction (MRI-PDFF) and liver histology in patients with biopsy-proven NASH. In this randomized, double-blind, placebo-controlled trial, 50 patients with biopsy-proven NASH were randomized to either ezetimibe 10 mg orally daily or placebo for 24 weeks. The primary outcome was a change in liver fat as measured by MRI-PDFF in colocalized regions of interest within each of the nine liver segments. Novel assessment by two-dimensional and three-dimensional magnetic resonance elastography was also performed. Ezetimibe was not significantly better than placebo at reducing liver fat as measured by MRI-PDFF (mean difference between the ezetimibe and placebo arms -1.3%, P = 0.4). Compared to baseline, however, end-of-treatment MRI-PDFF was significantly lower in the ezetimibe arm (15%-11.6%, P < 0.016) but not in the placebo arm (18.5%-16.4%, P = 0.15). There were no significant differences in histologic response rates, serum alanine aminotransferase and aspartate aminotransferase levels, or longitudinal changes in two-dimensional and three-dimensional magnetic resonance elastography-derived liver stiffness between the ezetimibe and placebo arms. Compared to histologic nonresponders (25/35), histologic responders (10/35) had a significantly greater reduction in MRI-PDFF (-4.35 ± 4.9% versus -0.30 ± 4.1%, P < 0.019).</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">25482832</PMID><DateCreated><Year>2015</Year><Month>03</Month><Day>26</Day></DateCreated><DateCompleted><Year>2015</Year><Month>06</Month><Day>01</Day></DateCompleted><DateRevised><Year>2015</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1527-3350</ISSN><JournalIssue CitedMedium="Internet"><Volume>61</Volume><Issue>4</Issue><PubDate><Year>2015</Year><Month>Apr</Month></PubDate></JournalIssue><Title>Hepatology (Baltimore, Md.)</Title><ISOAbbreviation>Hepatology</ISOAbbreviation></Journal><ArticleTitle>Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial).</ArticleTitle><Pagination><MedlinePgn>1239-50</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/hep.27647</ELocationID><Abstract><AbstractText Label="UNLABELLED">Ezetimibe inhibits intestinal cholesterol absorption and lowers low-density lipoprotein cholesterol. Uncontrolled studies have suggested that it reduces liver fat as estimated by ultrasound in nonalcoholic steatohepatitis (NASH). Therefore, we aimed to examine the efficacy of ezetimibe versus placebo in reducing liver fat by the magnetic resonance imaging-derived proton density-fat fraction (MRI-PDFF) and liver histology in patients with biopsy-proven NASH. In this randomized, double-blind, placebo-controlled trial, 50 patients with biopsy-proven NASH were randomized to either ezetimibe 10 mg orally daily or placebo for 24 weeks. The primary outcome was a change in liver fat as measured by MRI-PDFF in colocalized regions of interest within each of the nine liver segments. Novel assessment by two-dimensional and three-dimensional magnetic resonance elastography was also performed. Ezetimibe was not significantly better than placebo at reducing liver fat as measured by MRI-PDFF (mean difference between the ezetimibe and placebo arms -1.3%, P = 0.4). Compared to baseline, however, end-of-treatment MRI-PDFF was significantly lower in the ezetimibe arm (15%-11.6%, P < 0.016) but not in the placebo arm (18.5%-16.4%, P = 0.15). There were no significant differences in histologic response rates, serum alanine aminotransferase and aspartate aminotransferase levels, or longitudinal changes in two-dimensional and three-dimensional magnetic resonance elastography-derived liver stiffness between the ezetimibe and placebo arms. Compared to histologic nonresponders (25/35), histologic responders (10/35) had a significantly greater reduction in MRI-PDFF (-4.35 ± 4.9% versus -0.30 ± 4.1%, P < 0.019).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Ezetimibe did not significantly reduce liver fat in NASH. This trial demonstrates the application of colocalization of MRI-PDFF-derived fat maps and magnetic resonance elastography-derived stiffness maps of the liver before and after treatment to noninvasively assess treatment response in NASH.</AbstractText><CopyrightInformation>© 2014 The Authors. HEPATOLOGY published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Loomba</LastName><ForeName>Rohit</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>NAFLD Translational Research Unit, University of California at San Diego, La Jolla, CA; Division of Gastroenterology, Department of Medicine, University of California at San Diego, La Jolla, CA; Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sirlin</LastName><ForeName>Claude B</ForeName><Initials>CB</Initials></Author><Author ValidYN="Y"><LastName>Ang</LastName><ForeName>Brandon</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Bettencourt</LastName><ForeName>Ricki</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Jain</LastName><ForeName>Rashmi</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Salotti</LastName><ForeName>Joanie</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Soaft</LastName><ForeName>Linda</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Hooker</LastName><ForeName>Jonathan</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Kono</LastName><ForeName>Yuko</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Bhatt</LastName><ForeName>Archana</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Hernandez</LastName><ForeName>Laura</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Nguyen</LastName><ForeName>Phirum</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Noureddin</LastName><ForeName>Mazen</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Haufe</LastName><ForeName>William</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Hooker</LastName><ForeName>Catherine</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Yin</LastName><ForeName>Meng</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Ehman</LastName><ForeName>Richard</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Grace Y</ForeName><Initials>GY</Initials></Author><Author ValidYN="Y"><LastName>Valasek</LastName><ForeName>Mark A</ForeName><Initials>MA</Initials></Author><Author ValidYN="Y"><LastName>Brenner</LastName><ForeName>David A</ForeName><Initials>DA</Initials></Author><Author ValidYN="Y"><LastName>Richards</LastName><ForeName>Lisa</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><CollectiveName>San Diego Integrated NAFLD Research Consortium (SINC)</CollectiveName></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>R01 EB001981</GrantID><Acronym>EB</Acronym><Agency>NIBIB NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>02</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Hepatology</MedlineTA><NlmUniqueID>8302946</NlmUniqueID><ISSNLinking>0270-9139</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000924">Anticholesteremic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001384">Azetidines</NameOfSubstance></Chemical><Chemical><RegistryNumber>EOR26LQQ24</RegistryNumber><NameOfSubstance 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Techniques</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000069438">Ezetimibe</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D008279">Magnetic Resonance Imaging</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D065626">Non-alcoholic Fatty Liver Disease</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC4407930</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>9</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>12</Month><Day>3</Day></PubMedPubDate><PubMedPubDate PubStatus="aheadofprint"><Year>2015</Year><Month>2</Month><Day>27</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>12</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>12</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>6</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/hep.27647</ArticleId><ArticleId IdType="pubmed">25482832</ArticleId><ArticleId IdType="pmc">PMC4407930</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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