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

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

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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Crossref · 10.1002/hep.20646

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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
Venue
Hepatology
Published
2005-04
Volume
41
Issue
4
Pages
747-752
ISSN
0270-9139 (ISSN-L)
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
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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