Bezafibrate normalizes alkaline phosphatase in primary biliary cirrhosis patients with incomplete response to ursodeoxycholic acid
Abstract
Background & Aims: Ursodeoxycholic acid (UDCA) is the standard treatment for primary biliary cirrhosis (PBC) but excellent response is not observed in all cases. Since potential favourable effects of fibrates have been reported in short series with inconclusive results, we have carried out a pilot study to analyse the effects of bezafibrate in patients with suboptimal response to UDCA. Methods: Thirty women (age 52.3 ± 2.3 years) treated with UDCA and abnormal alkaline phosphatase (AP) levels received bezafibrate (400 mg/d) for 1 year. Changes were measured every 3 months during the study period of 12 months, 3 months after discontinuation and 3 months after resuming bezafibrate. Results: Two patients discontinued the treatment after few days, three at 6 and one at 9 months. Bezafibrate treatment resulted in a significant decrease in AP as early as 3 months. Normalization or decrease of AP below 1.5 times normal levels was observed in 13 and 4 patients respectively. There was also a significant decrease in γ‐glutamyl transferase and alanine aminotransferase, cholesterol and triglyceride levels. Bezafibrate treatment resulted in significant improvement of pruritus. A rebound in liver biochemistries and pruritus occurred upon drug discontinuation, changes which improved again after resuming bezafibrate. Response to bezafibrate was associated with lower liver stiffness and severity of cholestasis. No severe adverse effects were observed. Conclusions: Combination treatment of bezafibrate and UDCA is associated with marked decrease or normalization of alkaline phosphatase as early as 3 months in patients with PBC. Better biochemical response was observed in patients with early disease and lower cholestasis.
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An open-label study (n=28) provided evidence of a significant improvement in itch severity with bezafibrate, wherein all 12 patients who reported itch prior to starting treatment achieved complete or partial symptom resolution.
“Data from an open-label study (n=28) also provide evidence of a significant improvement in itch severity with bezafibrate, wherein all 12 patients who reported itch prior to starting treatment achieved complete or partial symptom resolution.165”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [165]
In that study, 20 and 24 UDCA non-responders attained a serum ALP reduction >40% within 6 and 12 months, respectively, with combination bezafibrate therapy.
“Moreover, 20 and 24 UDCA non-responders attained a serum ALP reduction >40% within 6 and 12 months, respectively, with combination bezafibrate therapy.”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [165]
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- Authors
- Lens, S., Leoz, M., Nazal, L., Bruguera, M., & Parés, A.
- Affiliations
- Hospital Clínic de Barcelona (ES)
- Corresponding author
- Parés, Albert
- Venue
- Liver International
- Publisher
- Wiley
- Published
- 2013-09-02
- Volume
- 34
- Issue
- 2
- Pages
- 197-203
- ISSN
- 0106-9543 (ISSN-L)
- 1478-3223
- 1478-3231
- OpenAlex
- W1990027295
- Cited by
- 107
- References
- 3
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 5 · 2023: 2 · 2022: 9 · 2021: 5 · 2020: 2 · 2019: 9 · 2018: 16 · 2017: 14 · 2016: 12 · 2015: 17 · 2014: 10 · 2013: 1
- FWCI
- 8.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Liver International (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas
- Instituto de Salud Carlos III (08/04012)
- Ministerio de Ciencia e Innovación
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Keywords
- bezafibrate, primary biliary cirrhosis, ursodeoxycholic acid, fibrates, combination therapy, pruritus, cholestasis, liver stiffness, liver biochemistry, drug discontinuation
- MeSH terms
- Alkaline Phosphatase, Bezafibrate, Female, Humans, Liver Cirrhosis, Biliary, Middle Aged, Pilot Projects, Prospective Studies, Ursodeoxycholic Acid, Treatment Outcome, Statistics, Nonparametric, Elasticity Imaging Techniques
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