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Budesonide combined with UDCA to improve liver histology in primary biliary cirrhosis: A three‐year randomized trial†
Open accessAbstract
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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“Moreover, in a subsequent 3-year randomised non-blinded study performed in non-cirrhotic PBC patients (n=77), budesonide 6 mg/day plus UDCA (n=46) was associated with a 25% regression in liver fibrosis.160”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [160]
In the citing paper
“However, despite encouraging results, note must be taken of a high rate of fibrosis progression (an increase of 70%) in patients receiving UDCA monotherapy.”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [160]
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Metadata
- 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
- 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
- bronze
- doi.org
- 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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