Lifestyle versus ezetimibe plus lifestyle in patients with biopsy-proven non-alcoholic steatohepatitis (LISTEN): A double-blind randomised placebo-controlled trial
Autor: | 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 |
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Přispěvatelé: | Noto D., Petta S., Giammanco A., Spina R., Cabibi D., Porcasi R., Caldarella R., Ciaccio M., Muratore R., Cefalu A.B., Craxi A., Averna M. |
Rok vydání: | 2021 |
Předmět: |
Settore MED/12 - Gastroenterologia
Nutrition and Dietetics Settore MED/09 - Medicina Interna Endocrinology Diabetes and Metabolism Biopsy Medicine (miscellaneous) Liver biopsy Ezetimibe Treatment Outcome Double-Blind Method Randomized controlled trial Non-alcoholic Fatty Liver Disease Humans Cardiology and Cardiovascular Medicine Non-alcoholic steatohepatiti Life Style |
Zdroj: | Nutrition, metabolism, and cardiovascular diseases : NMCD. 32(5) |
ISSN: | 1590-3729 |
Popis: | 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. |
Databáze: | OpenAIRE |
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