脂肪性肝炎
医学
以兹提米比
安慰剂
内科学
肝活检
优势比
随机对照试验
胃肠病学
脂肪肝
不利影响
活检
他汀类
病理
疾病
替代医学
作者
Davide Noto,Salvatore Petta,Antonina Giammanco,Rossella Spina,Daniela Cabibbi,Rossana Porcasi,Rosalia Caldarella,Marcello Ciaccio,Roberto Muratore,Angelo B. Cefalù,Antonio Craxi,Maurizio Averna
标识
DOI:10.1016/j.numecd.2022.01.024
摘要
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.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.ezetimibe administered on top of lifestyle and dietary modification failed to improve the histology of NASH in comparison with lifestyle and dietary modification alone.ClinicalTrial.gov: NCT01950884.
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