Cited by 222Liver Diseases and ImmunityPediatric Hepatobiliary Diseases and TreatmentsDrug-Induced Hepatotoxicity and Protection

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Budesonide combined with UDCA to improve liver histology in primary biliary cirrhosis: A three‐year randomized trial†

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Rautiainen, Henna, Kärkkäinen, Päivi, Karvonen, A‐L, Nurmi, Heimo, Pikkarainen, Pekka, Nuutinen, Hannu, Färkkilä, Martti·2005·Hepatology

DOI 10.1002/hep.20646

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Abstract

Ursodeoxycholic acid (UDCA) is a safe medical therapy for primary biliary cirrhosis (PBC), but its effect on liver histology remains uncertain. Budesonide is a glucocorticoid with high receptor activity and high first-pass metabolism in liver. We evaluated the combination of budesonide and UDCA on liver histology and compared this with UDCA alone in a 3-year prospective, randomized, open multicenter study. Patients with PBC (n = 77), at stages I to III, were randomized into 2 treatment arms, A (n = 41): budesonide 6 mg/d and UDCA 15 mg/kg/d and B (n = 36): UDCA 15 mg/kg/d. Liver histology was assessed at the beginning and at the end of the study. Liver function tests and glucose and cortisol values were determined every 4 months. Paired liver biopsy specimens were available from 69 patients (A = 37 and B = 32). Stage improved 22% in group A but deteriorated 20% in group B (P = .009). Fibrosis decreased 25% in group A but increased 70% in group B (P = .0009). S-PIIINP decreased significantly in group A. Inflammation decreased in both groups, 34% in group A (P = .02), but only 10% in group B (P = NS). Serum liver enzymes decreased significantly in both treatment arms. Bilirubin values rose in group B but stayed stable in group A (A/B P = .002). A mild systemic glucocorticoid effect from budesonide was evident after 2 years. In conclusion, budesonide combined with UDCA improved liver histology, whereas the effect of UDCA alone was mainly on laboratory values. Studies with longer follow-up using a combination of budesonide and UDCA are warranted to confirm safety and effects.

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Authors: Rautiainen, H., Kärkkäinen, P., Karvonen, A., Nurmi, H., Pikkarainen, P., Nuutinen, H., & Färkkilä, M.
Affiliations: Helsinki University Hospital (FI)
Tampere University Hospital (FI)
Turku University Hospital (FI)
Corresponding author: Rautiainen, Henna
ORCID: Färkkilä, Martti
Venue: Hepatology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2005-04
Volume: 41
Issue: 4
Pages: 747-752
ISSN: 0270-9139 (ISSN-L)
DOI: 10.1002/hep.20646
OpenAlex: W2089585697
Cited by: 222
References: 23
Citations by year: 2026: 1 · 2025: 4 · 2024: 6 · 2023: 4 · 2022: 9 · 2021: 6 · 2020: 15 · 2019: 9 · 2018: 11 · 2017: 13 · 2016: 13 · 2015: 18 · 2014: 19 · 2013: 9 · 2012: 11
FWCI: 7.81
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 3805 d)
Locations: Hepatology (publishedVersion)
PubMed (publishedVersion)
Funders: Mary and Georg C Ehrnrooth Foundation
Topics: Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
Keywords: primary biliary cirrhosis, budesonide, ursodeoxycholic acid, combination therapy, liver histopathology, liver fibrosis, liver inflammation, glucocorticoid adverse effects, serum bilirubin, liver function tests
MeSH terms: Adult, Aged, Drug Therapy, Combination, Glucocorticoids, Humans, Liver, Liver Cirrhosis, Liver Cirrhosis, Biliary, Middle Aged, Prospective Studies, Ursodeoxycholic Acid, Budesonide

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Budesonide combined with UDCA to improve liver histology in primary biliary cirrhosis: A three‐year randomized trial†

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