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
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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“There are three larger, placebo-controlled trials of UDCA in MASH differing in the dose of UDCA used 373 -375 and only two of them report histological endpoints.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [375]
Citations
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Chalasani, N., Younossi, Z., Lavine, J. E., Charlton, M., Cusi, K., Rinella, M., Harrison, S. A., Brunt, E. M., & Sanyal, A. J. (2018) · Hepatology · doi:10.1002/hep.29367 · Cited by 7,239
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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)
- 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
- 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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