High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis
Open accessAbstract
Previous controlled trials are inconclusive regarding the efficacy of ursodeoxycholic acid (UDCA) for treating primary sclerosing cholangitis (PSC). One hundred fifty adult patients with PSC were enrolled in a long-term, randomized, double-blind controlled trial of high-dose UDCA (28-30 mg/kg/day) versus placebo. Liver biopsy and cholangiography were performed before randomization and after 5 years. The primary outcome measures were development of cirrhosis, varices, cholangiocarcinoma, liver transplantation, or death. The study was terminated after 6 years due to futility. At enrollment, the UDCA (n = 76) and placebo (n = 74) groups were similar with respect to sex, age, duration of disease, serum aspartate aminotransferase and alkaline phosphatase levels, liver histology, and Mayo risk score. During therapy, aspartate aminotransferase and alkaline phosphatase levels decreased more in the UDCA group than the placebo group ( P < 0.01), but improvements in liver tests were not associated with decreased endpoints. By the end of the study, 30 patients in the UDCA group (39%) versus 19 patients in the placebo group (26%) had reached one of the pre-established clinical endpoints. After adjustment for baseline stratification characteristics, the risk of a primary endpoint was 2.3 times greater for patients on UDCA than for those on placebo ( P < 0.01) and 2.1 times greater for death, transplantation, or minimal listing criteria ( P = 0.038). Serious adverse events were more common in the UDCA group than the placebo group (63% versus 37% [ P < 0.01]). Conclusion: Long-term, high-dose UDCA therapy is associated with improvement in serum liver tests in PSC but does not improve survival and was associated with higher rates of serious adverse events. (Hepatology 2009.)
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A number of smaller pilot studies and larger RCTs demonstrated improvement of serum liver tests, except for 2 of them, but these studies were all underpowered for the identification of hard clinical outcome parameters such as death or liver transplantation.
“A number of smaller pilot studies and larger RCTs 13,80,[147][148][149][150][151][152][153][154][155][156] demonstrated improvement of serum liver tests (except for 2 of them 150,155 ), but these studies were all underpowered for the identification of”
From EASL Clinical Practice Guidelines on sclerosing cholangitis (2022) · cites this paper as [80]
Except for demonstrating the negative impact of high-dose UDCA (28-30 mg/kg), no systematic studies have evaluated the impact of treatment with medium or moderate dose UDCA on HVPG or the risk of portal hypertension-related complications in PSC.
“However, except for demonstrating the negative impact of high-dose UDCA (28-30 mg/kg), 80 no systematic studies have evaluated the impact of treatment with medium/moderate dose UDCA on HVPG or the risk of portal hypertension-related complications in PSC.”
From EASL Clinical Practice Guidelines on sclerosing cholangitis (2022) · cites this paper as [80]
Ursodeoxycholic acid is less effective in primary sclerosing cholangitis than in primary biliary cholangitis.
“while UDCA has proven beneficial effects in about 60% of PBC patients, it is less effective in PSC.(69)(70)(71)”
From The ascending pathophysiology of cholestatic liver disease (2017) · cites this paper as [71]
In a controlled trial, primary sclerosing cholangitis patients given high-dose UDCA had more portal hypertension-related complications than those given placebo.
“In a controlled trial PSC patients received high-dose UDCA or placebo.Patients allocated to the UDCA group developed more complications related to portal hypertension than placebo-treated patients.(71)”
From The ascending pathophysiology of cholestatic liver disease (2017) · cites this paper as [71]
Ursodeoxycholic acid produces beneficial effects in roughly 60% of patients with primary biliary cholangitis.
“while UDCA has proven beneficial effects in about 60% of PBC patients, it is less effective in PSC.(69)(70)(71)”
From The ascending pathophysiology of cholestatic liver disease (2017) · cites this paper as [71]
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Self-citation
- Authors
- Lindor, K. D., Kowdley, K. V., Luketic, V. A. C., Harrison, E. M., McCashland, T., Befeler, A. S., Harnois, D., Jorgensen, R., Petz, J., Keach, J., Mooney, J., Sargeant, C., Braaten, J., Bernard, T., King, D., Miceli, E., Schmoll, J., Hoskin, T., Thapa, P., & Enders, F.
- Affiliations
- Mayo Clinic (US)
- Virginia Mason Medical Center (US)
- Virginia Commonwealth University (US)
- University of Nebraska–Lincoln (US)
- Saint Louis University (US)
- Mayo Clinic in Arizona (US)
- Corresponding author
- Lindor, Keith D.
- ORCID
- Venue
- Hepatology
- Published
- 2009-09
- Volume
- 50
- Issue
- 3
- Pages
- 808-814
- ISSN
- 0270-9139 (ISSN-L)
- PMC
- PMC2758780
- OpenAlex
- W2133403920
- Cited by
- 720
- References
- 69
- Citations by year
- 2026: 24 · 2025: 27 · 2024: 33 · 2023: 26 · 2022: 28 · 2021: 45 · 2020: 47 · 2019: 46 · 2018: 39 · 2017: 48 · 2016: 47 · 2015: 45 · 2014: 44 · 2013: 50 · 2012: 58
- FWCI
- 36.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Hepatology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Virginia Commonwealth University
- U.S. Public Health Service (56924)
- National Institute of Diabetes and Digestive and Kidney Diseases (K24DK002957, R01DK056924)
- National Center for Research Resources (M01RR000065)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Inflammatory Bowel Disease
- Keywords
- ursodeoxycholic acid, primary sclerosing cholangitis, liver cirrhosis, cholangiocarcinoma, liver transplantation, varices, liver enzymes, adverse events, treatment efficacy, futility
- MeSH terms
- Adult, Aged, Alkaline Phosphatase, Aspartate Aminotransferases, Bilirubin, Cholagogues and Choleretics, Double-Blind Method, Female, Humans, Liver Function Tests, Male, Middle Aged, Ursodeoxycholic Acid, Cholangitis, Sclerosing, Liver Transplantation, Treatment Outcome, Kaplan-Meier Estimate
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