The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.
Effectiveness of Fenofibrate in Treatment-Naive Patients With Primary Biliary Cholangitis: A Randomized Clinical Trial
Abstract
INTRODUCTION: Primary biliary cholangitis (PBC) is a progressive autoimmune liver disease, and patients with inadequate response to ursodeoxycholic acid (UDCA) treatment show reduced long-term survival. Recent studies have shown that fenofibrate is an effective off-label therapy for PBC. However, prospective studies on biochemical response including the timing of fenofibrate administration are lacking. This study is aimed to evaluate the efficacy and safety of fenofibrate in UDCA treatment-naive patients with PBC. METHODS: A total of 117 treatment-naive patients with PBC were recruited from the Xijing Hospital for a 12-month randomized, parallel, and open-label clinical trial. Study participants were assigned to receive either UDCA standard dose (UDCA-only group) or fenofibrate at a daily dose of 200 mg in addition to UDCA (UDCA-Fenofibrate group). RESULTS: The primary outcome was biochemical response percentage in patients according to the Barcelona criterion at 12 months. In the UDCA-Fenofibrate group, 81.4% (69.9%–92.9%) of patients achieved the primary outcome and 64.3% (51.9%–76.8%) in the UDCA-only group achieved the primary outcome ( P = 0.048). There was no difference between the 2 groups in noninvasive measures of liver fibrosis and biochemical markers other than alkaline phosphatase at 12 months. Creatinine and transaminases levels in the UDCA-Fenofibrate group increased within the first month, then returned to normal, and remained stable thereafter until the end of the study, even in patients with cirrhosis. DISCUSSION: In this randomized clinical trial in treatment-naive patients with PBC, the combination of fenofibrate and UDCA resulted in a significantly higher biochemical response rate. Fenofibrate seemed to be well-tolerated in patients.
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In the citing paper
“In a randomized trial, creatinine and transaminases levels in the UDCA-fenofibrate dual therapy group increased within the first month, then returned to normal, and remained stable thereafter until the end of the study, even in patients with cirrhosis [15].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [15]
In the citing paper
“There is growing evidence that adding fenofibrate to UDCA in patients with UDCA-resistant PBC significantly improves biochemical markers, especially ALP.”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [15]
In the citing paper
“These effects collectively reduce cholesterol and hepatic inflammation, and it reflects by reductions in serum ALP and GGT levels [7,15,39].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [15]
In the citing paper
“The primary outcome, biochemical response at 12 months according to the Barcelona criterion, was achieved in 46/57 patients (81.4%) in the UDCA–fenofibrate group and 36/60 patients (64.3%) in the UDCA-only group, with a statistically significant difference (p = 0.048) [15].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [15]
In the citing paper
“However, there were no statistical differences between the UDCA–fenofibrate and UDCA-only groups in liver stiffness measured by transient elastography (p = 0.335), FIB-4 score (p = 0.692), and GGT (p = 0.605) [15].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [15]
In the citing paper
“From a comparative perspective, OCA and fibrates both achieve ALP reduction, but fibrates often provide greater biochemical response and potential pruritus relief, whereas OCA is limited by dose-dependent pruritus and contraindications in cirrhosis [15,22,27].”
From Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor (2025) · cites this paper as [15]
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BackgroundA Placebo-Controlled Trial of Bezafibrate in Primary Biliary Cholangitis
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Metadata
- Authors
- Liu, Y., Guo, G., Zheng, L., Sun, R., Wang, X., Deng, J., Jia, G., Yang, C., Cui, L., Guo, C., Shang, Y., & Han, Y.
- Affiliations
- National Clinical Research Center for Digestive Diseases (CN)
- Corresponding author
- Liu, Yansheng
- Guo, Guanya
- Zheng, Linhua
- Venue
- American Journal of Gastroenterology
- Published
- 2023-03-09
- Volume
- 118
- Issue
- 11
- Pages
- 1973-1979
- ISSN
- 0002-9270 (ISSN-L)
- 1572-0241
- OpenAlex
- W4323652914
- Cited by
- 55
- References
- 33
- Citations by year
- 2026: 18 · 2025: 19 · 2024: 15 · 2023: 3
- FWCI
- 9.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- 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, fenofibrate, ursodeoxycholic acid, combination therapy, treatment-naive patients, biochemical response, liver fibrosis, drug safety, liver cirrhosis, off-label therapy
- MeSH terms
- Cholagogues and Choleretics, Drug Therapy, Combination, Humans, Liver Cirrhosis, Biliary, Fenofibrate, Prospective Studies, Ursodeoxycholic Acid, Treatment Outcome
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