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Cited by 338Liver Disease Diagnosis and TreatmentLiver Diseases and ImmunityLiver physiology and pathology

The DOI matches its Crossref record; 58 of the 58 references it cites were found in a registry or an index.

A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis

Ratziu, Vlad, de Ledinghen, Victor, Oberti, Fréderic, Mathurin, Philippe, Wartelle-Bladou, Claire, Renou, Christophe, Sogni, Philippe, Maynard, Marianne, Larrey, Dominique, Serfaty, Lawrence, Bonnefont-Rousselot, Dominique, Bastard, Jean-Philippe, Rivière, Marc, Spénard, Jean·2011·Journal of Hepatology
DOI 10.1016/j.jhep.2010.08.030
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Abstract

Background & aims Nonalcoholic steatohepatitis (NASH) is a prevalent liver disease associated with increased morbidity and mortality. Ursodeoxycholic acid (UDCA) may have antioxidant, anti-inflammatory, and antifibrotic properties and may reduce liver injury in NASH. To date, no studies have assessed the efficacy and safety of high-dose UDCA (HD-UDCA) in patients with NASH.Methods We conducted a 12-month, randomized, double-blind, placebo-controlled multicenter trial to evaluate the efficacy and safety of HD-UDCA (28-35 mg/kg per day) in 126 patients with biopsy-proven NASH and elevated alanine aminotransferase (ALT) levels. The primary study end point was reduction in ALT levels from baseline in patients treated with HD-UDCA compared with placebo. Secondary study end points were the proportion of patients with ALT normalization, relative reduction in the scores of serum markers of fibrosis and hepatic inflammation, and safety and tolerability.Results HD-UDCA significantly reduced mean ALT levels -28.3% from baseline after 12 months compared with -1.6% with placebo (p<0.001). At the end of the trial, ALT levels normalized (≤35 IU/L) in 24.5% of patients treated with HD-UDCA and in 4.8% of patients who received placebo (p=0.003). Both results were not accounted for by changes in weight during the trial. HD-UDCA significantly reduced the FibroTest® serum fibrosis marker (p<0.001) compared with placebo. HD-UDCA also significantly improved markers of glycemic control and insulin resistance. There were no safety issues in this population.Conclusions Treatment with HD-UDCA was safe, improved aminotransferase levels, serum fibrosis markers, and selected metabolic parameters. Studies with histologic end points are warranted.

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  1. Kobak, 2002, Fat-laden hepatocytes are more prone to cellular necrosis than apoptosis when exposed to hydrophobic bile acids, Gastroenterology, 122, A642

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Metadata

Authors
Ratziu, V., de Ledinghen, V., Oberti, F., Mathurin, P., Wartelle-Bladou, C., Renou, C., Sogni, P., Maynard, M., Larrey, D., Serfaty, L., Bonnefont-Rousselot, D., Bastard, J.-P., Rivière, M., & Spénard, J.
Affiliations
  • Inserm (FR)
  • Centre Hospitalier Universitaire d'Angers (FR)
  • Hôpital Claude Huriez (FR)
  • Hôpital Cochin (FR)
  • Hospices Civils de Lyon (FR)
  • Centre Hospitalier Universitaire de Montpellier (FR)
  • Hôpital Saint-Antoine (FR)
  • Assistance Publique – Hôpitaux de Paris (FR)
  • Université de Montréal (CA)
Corresponding author
Ratziu, Vlad
ORCID
Venue
Journal of Hepatology
Publisher
Elsevier BV
Published
2011-05
Volume
54
Issue
5
Pages
1011-1019
ISSN
0168-8278 (ISSN-L)
DOI
10.1016/j.jhep.2010.08.030
OpenAlex
W2078519195
Cited by
338
References
58
Citations by year
2026: 10 · 2025: 20 · 2024: 24 · 2023: 21 · 2022: 18 · 2021: 26 · 2020: 13 · 2019: 25 · 2018: 14 · 2017: 18 · 2016: 18 · 2015: 32 · 2014: 22 · 2013: 33 · 2012: 33
FWCI
17.68
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of Hepatology (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
Funders
Axcan Pharma Inc
Topics
  • Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
  • Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
  • Health Sciences › Medicine › Hepatology › Liver physiology and pathology
Keywords
nonalcoholic steatohepatitis, ursodeoxycholic acid, alanine aminotransferase normalization, liver fibrosis, liver inflammation, insulin resistance, glycemic control, FibroTest, bile acid therapy
MeSH terms
Adult, Blood Glucose, Cholagogues and Choleretics, Dose-Response Relationship, Drug, Fatty Liver, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Insulin, Insulin Resistance, Male, Middle Aged, Ursodeoxycholic Acid, Treatment Outcome, Non-alcoholic Fatty Liver Disease

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