Effects of Switching from Fenofibrate to Pemafibrate for Asymptomatic Primary Biliary Cholangitis
Open accessAbstract
Background/Aims: The addition of a fibrate to ursodeoxycholic acid (UDCA) is the standard treatment for asymptomatic primary biliary cholangitis (aPBC) with an incomplete response to UDCA. Among the fibrates, bezafibrate and fenofibrate increase the serum creatinine level and reduce the estimated glomerular filtration rate (eGFR). Pemafibrate is an selective peroxisome proliferator-activated receptor alpha modulator (SPPARM-α) mainly metabolized by the liver that was recently approved to treat dyslipidemia. This study confirmed the changes in the biochemical markers after switching from fenofibrate to pemafibrate in aPBC patients. Methods: This study examined the effects of switching treatment from fenofibrate to pemafibrate in 16 aPBC patients. The biological parameters of these patients were examined at the initiation of fenofibrate and after switching to pemafibrate, then at 24 and 48 weeks later, respectively. Results: Among patients with aPBC treated with UDCA and fenofibrate, the ALP, GGT, and serum IgM levels decreased significantly (p<0.0001) over 48 weeks. On the other hand, serum creatinine levels increased significantly, and eGFR decreased significantly (p<0.0001). After switching to pemafibrate plus UDCA, patients with aPBC exhibited significantly lower serum creatinine levels (p=0.007) and significantly higher eGFR levels (p=0.014). Conclusions: Pemafibrate has therapeutic efficacy for aPBC patients with an inadequate response to UDCA. Pemafibrate might be another option for aPBC patients given its beneficial effects on renal function, but larger, multicenter studies with a longer follow-up are needed.
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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 [107]
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- Authors
- Dohmen, K., Onohara, S.-Y., & Harada, S.
- Affiliations
- Chihaya Hospital (JP)
- Corresponding author
- Dohmen, Kazufumi
- ORCID
- Dohmen, Kazufumi
- Venue
- The Korean Journal of Gastroenterology
- Published
- 2021-10-25
- Volume
- 78
- Issue
- 4
- Pages
- 227-234
- ISSN
- 1598-9992 (ISSN-L)
- 2233-6869
- PMC
- PMC12286480
- OpenAlex
- W3209074017
- Cited by
- 18
- References
- 53
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 3 · 2023: 5 · 2022: 4
- FWCI
- 1.67
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Korean Journal of Gastroenterology (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- PubMed Central (publishedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- 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, fenofibrate, primary biliary cirrhosis, ursodeoxycholic acid, renal function, estimated glomerular filtration rate, serum creatinine, liver enzymes, serum IgM, treatment response
- MeSH terms
- Hypolipidemic Agents, Benzoxazoles, Butyrates, Humans, Liver Cirrhosis, Biliary, Fenofibrate, Ursodeoxycholic Acid
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