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Lifestyle versus ezetimibe plus lifestyle in patients with biopsy-proven non-alcoholic steatohepatitis (LISTEN): A double-blind randomised placebo-controlled trial

  • Author Footnotes
    1 These authors equally contributed to the paper.
    Davide Noto
    Correspondence
    Corresponding author. Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Via del Vespro 141, I90127 Palermo, Italy.
    Footnotes
    1 These authors equally contributed to the paper.
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Author Footnotes
    1 These authors equally contributed to the paper.
    Salvatore Petta
    Footnotes
    1 These authors equally contributed to the paper.
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Author Footnotes
    1 These authors equally contributed to the paper.
    Antonina Giammanco
    Footnotes
    1 These authors equally contributed to the paper.
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Rossella Spina
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Daniela Cabibbi
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Rossana Porcasi
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    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Rosalia Caldarella
    Affiliations
    Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy
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  • Marcello Ciaccio
    Affiliations
    Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy
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  • Roberto Muratore
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Angelo B. Cefalù
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Antonio Craxi
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy
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  • Maurizio Averna
    Correspondence
    Corresponding author. Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Via del Vespro 141, I90127 Palermo, Italy.
    Affiliations
    Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy

    Istituto di Biofisica, Consiglio Nazionale delle Ricerche, Palermo, Italy
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  • Author Footnotes
    1 These authors equally contributed to the paper.
Published:January 27, 2022DOI:https://doi.org/10.1016/j.numecd.2022.01.024

      Highlights

      • Ezetimibe is lipid lowering drug able to promote cholesterol efflux from the liver.
      • Ezetimibe has been proposed to treat NAFLD.
      • Ezetimibe use in NAFLD has been tested in a randomized controlled trial.
      • Ezetimibe failed to improve NAFLD features measured by liver biopsies.
      • Diet and Lifestyle remain the main therapeutic options for NAFLD.

      Abstract

      Background and aims

      The LISTEN trial (ClinicalTrial.gov accession: NCT01950884) is a phase IV 52 weeks double blind parallel randomized controlled trial that evaluated the effect of ezetimibe plus lifestyle and dietary intervention (eze) vs. lifestyle and dietary intervention alone (placebo) on progression and complications of non-alcoholic steatohepatitis (NASH) evaluated by liver histology.

      Methods and results

      Forty patients with NASH ascertained by histology were randomly allocated on the two study groups and subjected to a follow-up of 52 weeks, when they underwent a second liver biopsy. Main composite end point (EP) was based on the histological improvement in the severity of NASH.
      Thirty patients completed the study, Eze treatment was not able to improve the primary EP in comparison with placebo, with and odds ratio of 1.029 (0.18–6.38), p = 0.974. Treatment emergent adverse events registered during the study were not more prevalent in the treatment arm.

      Conclusions

      ezetimibe administered on top of lifestyle and dietary modification failed to improve the histology of NASH in comparison with lifestyle and dietary modification alone.

      Trial accession number

      ClinicalTrial.gov: NCT01950884.

      Keywords

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