Primary sclerosing cholangitis response to the combination of fibrates with ursodeoxycholic acid: French-Spanish experience
Open accessAbstract
Background & aims In patients with primary sclerosing cholangitis (PSC), ursodeoxycholic acid (UDCA) treatment improves serum liver tests and surrogate markers of prognosis but has no proven effect on survival. Additional therapies are obviously needed. Fibrates, PPAR agonists with anti-cholestatic properties, have a beneficial effect in primary biliary cholangitis. The aim of this study was to evaluate the safety and efficacy of fibrates in PSC patients.Methods Retrospectively, we investigated PSC patients treated with fibrates (fenofibrate 200mg/day or bezafibrate 400mg/day) for at least 6 months in addition to UDCA, after an incomplete biochemical response (alkaline phosphatase [ALP] ≥1.5×upper limit of normal) to UDCA. Changes in biochemical parameters and clinical features were assessed.Results Twenty patients were included (fourteen from Paris and six from Barcelona): median age 43.8 years, median liver stiffness 11kPa (≥F3). Upon treatment with fibrates (median duration of 1.56 years), liver tests significantly improved, including a reduction of ALP levels by 41% and pruritus significantly decreased. No serious adverse event attributable to fibrates occurred. Discontinuation of fibrates was followed by a clear rebound of ALP. Despite biochemical improvement, liver stiffness significantly increased.Conclusions Combining UDCA with fibrates results in a significant biochemical improvement and pruritus decrease in PSC patients with incomplete response to UDCA. These results provide a rationale for larger and prospectively designed studies to establish the efficacy and safety of fibrates in PSC.
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Beneficial effects of fibrates on cholestasis-associated pruritus have been reported in case series for PBC (bezafibrate) and PSC (fenofibrate).
“Beneficial effects of fibrates on cholestasis-associated pruritus have most recently been reported in case series for PBC (bezafibrate) 18 and PSC (fenofibrate).28”
From Fibrates for Itch (FITCH) in Fibrosing Cholangiopathies: A Double-Blind, Randomized, Placebo-Controlled Trial (2021) · cites this paper as [28]
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- Authors
- Lemoinne, S., Pares, A., Reig, A., Ben Belkacem, K., Kemgang Fankem, A. D., Gaouar, F., Poupon, R., Housset, C., Corpechot, C., & Chazouillères, O.
- Affiliations
- Inserm (FR)
- Centro de Investigación Biomédica en Red (ES)
- Assistance Publique – Hôpitaux de Paris (FR)
- Corresponding author
- Chazouillères, Olivier
- ORCID
- Venue
- Clinics and Research in Hepatology and Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2018-12
- Volume
- 42
- Issue
- 6
- Pages
- 521-528
- ISSN
- 2210-7401 (ISSN-L)
- OpenAlex
- W2885245587
- Cited by
- 74
- References
- 31
- Citations by year
- 2026: 9 · 2025: 11 · 2024: 13 · 2023: 8 · 2022: 9 · 2021: 9 · 2020: 8 · 2019: 5 · 2018: 1 · 2012: 1
- FWCI
- 3.60
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- Clinics and Research in Hepatology and Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Keywords
- primary sclerosing cholangitis, fibrates, fenofibrate, bezafibrate, ursodeoxycholic acid, combination therapy, alkaline phosphatase, pruritus, liver stiffness, PPAR agonists, drug safety
- MeSH terms
- Adult, Aged, Alkaline Phosphatase, Hypolipidemic Agents, Bezafibrate, Cholagogues and Choleretics, Drug Therapy, Combination, Female, France, Humans, Liver Function Tests, Male, Middle Aged, Fenofibrate, Pruritus, Retrospective Studies, Spain, Ursodeoxycholic Acid, Cholangitis, Sclerosing, Young Adult
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