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 : 000064 ( Main/Exploration ); précédent : 000063; suivant : 000065Ezetimibe 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 [États-Unis] ; Brandon Ang [États-Unis] ; Ricki Bettencourt [États-Unis] ; Rashmi Jain [États-Unis] ; Joanie Salotti [États-Unis] ; Linda Soaft [États-Unis] ; Jonathan Hooker [États-Unis] ; Yuko Kono [États-Unis] ; Archana Bhatt [États-Unis] ; Laura Hernandez [États-Unis] ; Phirum Nguyen [États-Unis] ; Mazen Noureddin [États-Unis] ; William Haufe [États-Unis] ; Catherine Hooker [États-Unis] ; Meng Yin [États-Unis] ; Richard Ehman [États-Unis] ; Grace Y. Lin [États-Unis] ; Mark A. Valasek [États-Unis] ; David A. Brenner [États-Unis] ; Lisa Richards [États-Unis]Source :
- Hepatology (Baltimore, Md.) [ 0270-9139 ] ; 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%,
Url:
DOI: 10.1002/hep.27647
PubMed: 25482832
PubMed Central: 4407930
Affiliations:
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Le document en format XML
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<author><name sortKey="Bettencourt, Ricki" sort="Bettencourt, Ricki" uniqKey="Bettencourt R" first="Ricki" last="Bettencourt">Ricki Bettencourt</name>
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<author><name sortKey="Jain, Rashmi" sort="Jain, Rashmi" uniqKey="Jain R" first="Rashmi" last="Jain">Rashmi Jain</name>
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<author><name sortKey="Salotti, Joanie" sort="Salotti, Joanie" uniqKey="Salotti J" first="Joanie" last="Salotti">Joanie Salotti</name>
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<affiliation wicri:level="2"><nlm:aff id="au2"><institution>Division of Gastroenterology, Department of Medicine, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Soaft, Linda" sort="Soaft, Linda" uniqKey="Soaft L" first="Linda" last="Soaft">Linda Soaft</name>
<affiliation wicri:level="2"><nlm:aff id="au1"><institution>NAFLD Translational Research Unit, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2"><nlm:aff id="au2"><institution>Division of Gastroenterology, Department of Medicine, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hooker, Jonathan" sort="Hooker, Jonathan" uniqKey="Hooker J" first="Jonathan" last="Hooker">Jonathan Hooker</name>
<affiliation wicri:level="2"><nlm:aff id="au4"><institution>Liver Imaging Group, Department of Radiology, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Kono, Yuko" sort="Kono, Yuko" uniqKey="Kono Y" first="Yuko" last="Kono">Yuko Kono</name>
<affiliation wicri:level="2"><nlm:aff id="au2"><institution>Division of Gastroenterology, Department of Medicine, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Bhatt, Archana" sort="Bhatt, Archana" uniqKey="Bhatt A" first="Archana" last="Bhatt">Archana Bhatt</name>
<affiliation wicri:level="2"><nlm:aff id="au1"><institution>NAFLD Translational Research Unit, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hernandez, Laura" sort="Hernandez, Laura" uniqKey="Hernandez L" first="Laura" last="Hernandez">Laura Hernandez</name>
<affiliation wicri:level="2"><nlm:aff id="au1"><institution>NAFLD Translational Research Unit, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Nguyen, Phirum" sort="Nguyen, Phirum" uniqKey="Nguyen P" first="Phirum" last="Nguyen">Phirum Nguyen</name>
<affiliation wicri:level="2"><nlm:aff id="au1"><institution>NAFLD Translational Research Unit, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2"><nlm:aff id="au2"><institution>Division of Gastroenterology, Department of Medicine, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Noureddin, Mazen" sort="Noureddin, Mazen" uniqKey="Noureddin M" first="Mazen" last="Noureddin">Mazen Noureddin</name>
<affiliation wicri:level="2"><nlm:aff id="au1"><institution>NAFLD Translational Research Unit, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2"><nlm:aff id="au2"><institution>Division of Gastroenterology, Department of Medicine, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Haufe, William" sort="Haufe, William" uniqKey="Haufe W" first="William" last="Haufe">William Haufe</name>
<affiliation wicri:level="2"><nlm:aff id="au4"><institution>Liver Imaging Group, Department of Radiology, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Hooker, Catherine" sort="Hooker, Catherine" uniqKey="Hooker C" first="Catherine" last="Hooker">Catherine Hooker</name>
<affiliation wicri:level="2"><nlm:aff id="au4"><institution>Liver Imaging Group, Department of Radiology, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Yin, Meng" sort="Yin, Meng" uniqKey="Yin M" first="Meng" last="Yin">Meng Yin</name>
<affiliation wicri:level="2"><nlm:aff id="au5"><institution>Department of Radiology, Mayo Clinic</institution>
<addr-line>Rochester, MN</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Rochester</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Ehman, Richard" sort="Ehman, Richard" uniqKey="Ehman R" first="Richard" last="Ehman">Richard Ehman</name>
<affiliation wicri:level="2"><nlm:aff id="au5"><institution>Department of Radiology, Mayo Clinic</institution>
<addr-line>Rochester, MN</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Rochester</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Lin, Grace Y" sort="Lin, Grace Y" uniqKey="Lin G" first="Grace Y" last="Lin">Grace Y. Lin</name>
<affiliation wicri:level="2"><nlm:aff id="au6"><institution>Department of Pathology, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Valasek, Mark A" sort="Valasek, Mark A" uniqKey="Valasek M" first="Mark A" last="Valasek">Mark A. Valasek</name>
<affiliation wicri:level="2"><nlm:aff id="au6"><institution>Department of Pathology, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Brenner, David A" sort="Brenner, David A" uniqKey="Brenner D" first="David A" last="Brenner">David A. Brenner</name>
<affiliation wicri:level="2"><nlm:aff id="au2"><institution>Division of Gastroenterology, Department of Medicine, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Richards, Lisa" sort="Richards, Lisa" uniqKey="Richards L" first="Lisa" last="Richards">Lisa Richards</name>
<affiliation wicri:level="2"><nlm:aff id="au1"><institution>NAFLD Translational Research Unit, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
<affiliation wicri:level="2"><nlm:aff id="au2"><institution>Division of Gastroenterology, Department of Medicine, University of California at San Diego</institution>
<addr-line>La Jolla, CA</addr-line>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>La Jolla</wicri:cityArea>
</affiliation>
</author>
</analytic>
<series><title level="j">Hepatology (Baltimore, Md.)</title>
<idno type="ISSN">0270-9139</idno>
<idno type="e-ISSN">1527-3350</idno>
<imprint><date when="2015">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"><p>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%, <italic>P</italic>
= 0.4). Compared to baseline, however, end-of-treatment MRI-PDFF was significantly lower in the ezetimibe arm (15%-11.6%, <italic>P</italic>
< 0.016) but not in the placebo arm (18.5%-16.4%, <italic>P</italic>
= 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%, <italic>P</italic>
< 0.019). <italic>Conclusions</italic>
: 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. (H<sc>epatology</sc>
2015;61:1239–1250)</p>
</div>
</front>
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</div1>
</back>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Minnesota</li>
</region>
</list>
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<name sortKey="Hooker, Catherine" sort="Hooker, Catherine" uniqKey="Hooker C" first="Catherine" last="Hooker">Catherine Hooker</name>
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<name sortKey="Kono, Yuko" sort="Kono, Yuko" uniqKey="Kono Y" first="Yuko" last="Kono">Yuko Kono</name>
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<name sortKey="Nguyen, Phirum" sort="Nguyen, Phirum" uniqKey="Nguyen P" first="Phirum" last="Nguyen">Phirum Nguyen</name>
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<name sortKey="Noureddin, Mazen" sort="Noureddin, Mazen" uniqKey="Noureddin M" first="Mazen" last="Noureddin">Mazen Noureddin</name>
<name sortKey="Richards, Lisa" sort="Richards, Lisa" uniqKey="Richards L" first="Lisa" last="Richards">Lisa Richards</name>
<name sortKey="Richards, Lisa" sort="Richards, Lisa" uniqKey="Richards L" first="Lisa" last="Richards">Lisa Richards</name>
<name sortKey="Salotti, Joanie" sort="Salotti, Joanie" uniqKey="Salotti J" first="Joanie" last="Salotti">Joanie Salotti</name>
<name sortKey="Salotti, Joanie" sort="Salotti, Joanie" uniqKey="Salotti J" first="Joanie" last="Salotti">Joanie Salotti</name>
<name sortKey="Sirlin, Claude B" sort="Sirlin, Claude B" uniqKey="Sirlin C" first="Claude B" last="Sirlin">Claude B. Sirlin</name>
<name sortKey="Soaft, Linda" sort="Soaft, Linda" uniqKey="Soaft L" first="Linda" last="Soaft">Linda Soaft</name>
<name sortKey="Soaft, Linda" sort="Soaft, Linda" uniqKey="Soaft L" first="Linda" last="Soaft">Linda Soaft</name>
<name sortKey="Valasek, Mark A" sort="Valasek, Mark A" uniqKey="Valasek M" first="Mark A" last="Valasek">Mark A. Valasek</name>
<name sortKey="Yin, Meng" sort="Yin, Meng" uniqKey="Yin M" first="Meng" last="Yin">Meng Yin</name>
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</affiliations>
</record>
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