Bezafibrate treatment: a new medical approach for PBC patients?
Abstract
Background A new medical approach to primary biliary cirrhosis (PBC) has been desired. We investigated the feasibility of using combination ursodeoxycholic acid (UDCA)-bezafibrate therapy in patients with PBC nonresponsive to UDCA monotherapy. Methods During a 6-month period, 22 PBC patients with elevated serum alkaline phosphatase (ALP) despite UDCA monotherapy received either UDCA at 600 mg/day (control group) or UDCA at 600 mg/day plus bezafibrate at 400 mg/day (bezafibrate group). Each patient underwent detailed clinical and biochemical evaluation. Results During treatment, changes in ALP level were greater in the bezafibrate group than in the control group (P< 0.01). During and at the end of treatment, serum ALP levels were significantly lower than those before treatment in patients receiving UDCA plus bezafibrate (P< 0.05). At the end of the 6 months, normalization of serum ALP was observed in 5 of 11 (45.4%) patients given bezafibrate and in 2 of 11 (18.1%) patients not given bezafibrate (P< 0.16). Bile acid proportions during the combination therapy did not change. Pruritus disappeared in 1 of 7 bezafibrate-group patients with this symptom. Conclusions UDCA at 600 mg/day plus bezafibrate at 400 mg/day may be considered as a new therapeutic option for patients with PBC.
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Studies from the 1990s evaluated the use of bezafibrate (400 mg/day) as an adjunctive therapy to UDCA, in which normalisation of serum ALP was reported in ~45% of UDCA non-responders versus ~18% taking placebo.
“Studies from the 1990s evaluated the use of bezafibrate (400 mg/day) as an adjunctive therapy to UDCA, in which normalisation of serum ALP was reported in ~45% of UDCA non-responders versus ~18% taking placebo.163”
From The British Society of Gastroenterology/UK-PBC primary biliary cholangitis treatment and management guidelines (2018) · cites this paper as [163]
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Bezafibrate for primary biliary cirrhosis
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Hepatobiliary membrane transporters in primary biliary cirrhosis
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Efficacy of fibrates in the treatment of primary biliary cholangitis: a meta-analysis
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Current and promising therapy for primary biliary cholangitis
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Optimal drug regimens for primary biliary cirrhosis: a systematic review and network meta-analysis
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Proposed therapies in primary biliary cholangitis
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The Inconvenient Truth of Primary Biliary Cholangitis/Autoimmune Hepatitis Overlap Syndrome
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The treatment of primary biliary cholangitis: from shadow to light
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Novel Therapies on Primary Biliary Cirrhosis
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Treatment of Primary Biliary Cholangitis
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Treatment of primary biliary cirrhosis: Is there more to offer than ursodeoxycholic acid?
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Therapeutic advances for primary biliary cholangitis: the old and the new
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No more pilots, a phase III trial of fibrates in primary biliary cirrhosis is long overdue!
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Fibrates and Fibrate-induced Liver Injury in Primary Biliary Cholangitis
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Chronic cholestatic liver diseases - Primary biliary cholangitis and Primary sclerosing cholangitis
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Meta‐Analysis: PPAR Agonists for Pruritus and Quality of Life in Primary Biliary Cholangitis
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Self-citationPrimary biliary cholangitis: assessment and management strategies
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- Authors
- Kanda, T., Yokosuka, O., Imazeki, F., & Saisho, H.
- Affiliations
- Chiba University (JP)
- Venue
- Journal of Gastroenterology
- Published
- 2003-06
- Volume
- 38
- Issue
- 6
- Pages
- 573-578
- ISSN
- 0944-1174 (ISSN-L)
- 1435-5922
- OpenAlex
- W1532206343
- Cited by
- 129
- References
- 41
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 5 · 2023: 2 · 2022: 7 · 2021: 8 · 2020: 3 · 2019: 5 · 2018: 7 · 2017: 6 · 2016: 4 · 2015: 12 · 2014: 11 · 2013: 6 · 2012: 5
- FWCI
- 3.49
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- 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
- primary biliary cirrhosis, bezafibrate, ursodeoxycholic acid, combination therapy, serum alkaline phosphatase, pruritus, bile acid composition
- MeSH terms
- Alkaline Phosphatase, Hypolipidemic Agents, Bezafibrate, Bile Acids and Salts, Cholagogues and Choleretics, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Liver Cirrhosis, Biliary, Male, Middle Aged, Time Factors, Ursodeoxycholic Acid
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