Biochemical and plasma lipid responses to pemafibrate in patients with primary biliary cholangitis
Abstract
Aim: Fibrate addition to ursodeoxycholic acid (UDCA) therapy has been shown to improve both liver biochemistry and long‐term prognosis in primary biliary cholangitis (PBC) patients showing an incomplete biochemical response to UDCA alone. We herein describe the clinical outcome of seven cases of PBC that received the new selective peroxisome proliferator‐activated receptor α modulator, pemafibrate, in combination with UDCA therapy to investigate the biochemical and plasma lipid responses to the drug. Methods: Of 124 initially enrolled PBC patients, 12 treated with UDCA alone and seven receiving UDCA plus bezafibrate showed alkaline phosphatase (ALP) levels above the upper limit of normal (330 U/L). Ultimately, seven patients with PBC and dyslipidemia who had agreed to biweekly visits at our hospital for UDCA plus pemafibrate combination therapy were retrospectively analyzed. Results: In the four cases that switched from bezafibrate to pemafibrate, ALP became significantly decreased (0.031) and γ‐glutamyltransferase tended to decrease (0.063) over the 3 months following pemafibrate addition. Two patients showed a greater than 50% reduction in ALP. No remarkable differences were observed for plasma lipid levels, alanine aminotransferase, aspartate aminotransferase, or the liver fibrosis marker Mac‐2 binding protein glycosylation isomer between these time points. No adverse drug reactions were recorded. Conclusions: Pemafibrate might be another option for PBC patients with an incomplete response to UDCA therapy.
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Pemafibrate showed a biochemical efficacy signal in a series of Japanese primary biliary cholangitis patients with an incomplete response to ursodeoxycholic acid.
“Last, pemafibrate, although not licensed for primary biliary cholangitis, showed a biochemical efficacy signal in a series of Japanese primary biliary cholangitis patients with an incomplete response to ursodeoxycholic acid.[107][108][109]”
From Primary biliary cholangitis. (2024) · cites this paper as [108]
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- Authors
- Joshita, S., Umemura, T., Yamashita, Y., Sugiura, A., Yamazaki, T., Fujimori, N., Matsumoto, A., & Tanaka, E.
- Affiliations
- Shinshu University (JP)
- Department of Medicine, Division of Gastroenterology and Hepatology Shinshu University School of Medicine Matsumoto Japan
- Corresponding author
- Joshita, Satoru
- Venue
- Hepatology Research
- Publisher
- Wiley
- Published
- 2019-06-14
- Volume
- 49
- Issue
- 10
- Pages
- 1236-1243
- ISSN
- 1386-6346 (ISSN-L)
- 1872-034X
- OpenAlex
- W2943905083
- Cited by
- 38
- References
- 32
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 5 · 2023: 6 · 2022: 7 · 2021: 5 · 2020: 4 · 2019: 2
- FWCI
- 2.87
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Hepatology Research (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Japan Society for the Promotion of Science (17K09416)
- 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
- pemafibrate, primary biliary cirrhosis, ursodeoxycholic acid, bezafibrate, fibrate therapy, dyslipidemia, plasma lipids, alkaline phosphatase, gamma-glutamyl transferase, liver biochemistry
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