Determinants of the effectiveness of bezafibrate combined with ursodeoxycholic acid in patients with primary biliary cholangitis
Abstract
BACKGROUND AND AIMS: For patients with primary biliary cholangitis (PBC) exhibiting suboptimal responses to ursodeoxycholic acid (UDCA), obeticholic acid (OCA), and bezafibrate (BZF) are currently used and shown to improve long-term outcomes. Nevertheless, we encounter patients who die or undergo liver transplantation (LT) even with combination treatment. In this study, we explored prognostic indicators in patients receiving combination treatment of UDCA and BZF. METHODS: We took advantage of the Japanese PBC registry and enrolled patients who received both UDCA and BZF therapy in 2000 or later. The covariates investigated included baseline covariates as well as treatment covariates. Two main outcomes (all-cause death or LT and liver-related death or LT) were assessed using multivariable-adjusted Cox proportional hazards models. RESULTS: In total, 772 patients were included. The median follow-up was 7.1 years. Using the Cox regression model, bilirubin (hazard ratio [HR] 6.85, 95% confidence interval [CI] 1.73-27.1, p = 0.006), alkaline phosphatase (HR 5.46, 95% CI 1.32-22.6, p = 0.019), and histological stage (HR 4.87, 95% CI 1.16-20.5, p = 0.031) were found associated with LT-free survival. For survival free from liver disease-related death or LT, albumin (HR 7.72, 95% CI 1.48-40.4, p = 0.016) and bilirubin (HR 14.5, 95% CI 2.37-88.5, p = 0.004) were found significantly associated. CONCLUSION: In patients with PBC receiving combination therapy, prognostic variables were similar to those in patients receiving UDCA monotherapy. These results indicate the importance of diagnosing patients with PBC at an earlier stage because of the reduced effectiveness of BZF at advanced stages.
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The diminished treatment response observed in patients with advanced disease indicates a crucial need for improved access to medical care, enabling earlier diagnosis and initiation of treatment for primary biliary cholangitis.
“However, the diminished treatment response observed in patients with advanced disease 129 indicates a crucial need for improved access to medical care, enabling earlier diagnosis and initiation of treatment for primary biliary cholangitis.”
From Primary biliary cholangitis. (2024) · cites this paper as [129]
Japanese data showed that bezafibrate was less effective in patients with advanced primary biliary cholangitis presenting with baseline hypoalbuminaemia and hyperbilirubinaemia.
“Additionally, Japanese data showed that bezafibrate was less effective in patients with advanced primary biliary cholangitis presenting with baseline hypoalbuminaemia and hyperbilirubinaemia. 129”
From Primary biliary cholangitis. (2024) · cites this paper as [129]
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Self-citation
- Authors
- Matsumoto, K., Hirohara, J., Takeuchi, A., Miura, R., Asaoka, Y., Nakano, T., & Tanaka, A.
- Affiliations
- Teikyo University (JP)
- Kansai Medical University (JP)
- Corresponding author
- Takeuchi, Akihito
- Tanaka, Atsushi
- Venue
- Hepatology Research
- Publisher
- Wiley
- Published
- 2023-06-21
- Volume
- 53
- Issue
- 10
- Pages
- 989-997
- ISSN
- 1386-6346 (ISSN-L)
- 1872-034X
- OpenAlex
- W4379779365
- Cited by
- 12
- References
- 10
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 6 · 2023: 2
- FWCI
- 2.03
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Hepatology Research (publishedVersion)
- PubMed (publishedVersion)
- Institutional Repositories DataBase (IRDB) (submittedVersion)
- Topics
- Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
- Health Sciences › Medicine › Surgery › Pediatric Hepatobiliary Diseases and Treatments
- Health Sciences › Medicine › Oncology › Drug Transport and Resistance Mechanisms
- Keywords
- primary biliary cirrhosis, bezafibrate, ursodeoxycholic acid, combination therapy, prognostic factors, liver transplantation, all-cause mortality, liver-related mortality, bilirubin, alkaline phosphatase, albumin, histological stage, stage at diagnosis
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