European journal of gastroenterology & hepatology · 2026
Fenofibrate add-on therapy improves transplant-free survival in primary biliary cholangitis patients.
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Li Buer, Li Shuxiang, Chen Sha, Li Min, Lv Tingting, Wang Qianyi, Wang Xiaoming, Wang Yu, Ma Hong, Ou Xiaojuan, Zhao Xinyan, Kong Yuanyuan, You Hong, Duan Weijia, Jia Jidong
Аннотация
BACKGROUND: Fenofibrate has shown biochemical benefit in primary biliary cholangitis (PBC) patients with a suboptimal response to ursodeoxycholic acid (UDCA), but its long-term efficacy on survival remains unknown.
METHODS: In this retrospective-prospective cohort study, we enrolled 160 PBC patients with a suboptimal response to UDCA and followed up on these patients to obtain laboratory results and adverse events. Finally, we evaluated long-term survivals analyzed with Kaplan-Meier plotting and log-rank test.
RESULTS: The fenofibrate add-on therapy group showed more significant improvements in alkaline phosphatase (ALP) and gamma-glutamyl transferase levels compared with UDCA monotherapy group after 1 year of treatment, resulting in a normalization rate of 60.9% for ALP and 45.3% for both ALP and total bilirubin. Importantly, compared with UDCA monotherapy group, the fenofibrate add-on therapy group had a better transplant-free survivals of 5 (89.7 vs 75.3%) and 10 years (87.0 vs 47.6%), with a hazard ratio of 0.3282 (95% confidence interval: 0.1334-0.8073, P < 0.05). Twenty-one cases (25.6%) developed adverse events, with liver injury being the most frequent one (17.1%).
CONCLUSION: Fenofibrate add-on therapy improved not only biochemical responses but also long-term transplant-free survival in PBC patients with suboptimal response to UDCA. However, liver injury needs to be closely monitored and properly managed.
METHODS: In this retrospective-prospective cohort study, we enrolled 160 PBC patients with a suboptimal response to UDCA and followed up on these patients to obtain laboratory results and adverse events. Finally, we evaluated long-term survivals analyzed with Kaplan-Meier plotting and log-rank test.
RESULTS: The fenofibrate add-on therapy group showed more significant improvements in alkaline phosphatase (ALP) and gamma-glutamyl transferase levels compared with UDCA monotherapy group after 1 year of treatment, resulting in a normalization rate of 60.9% for ALP and 45.3% for both ALP and total bilirubin. Importantly, compared with UDCA monotherapy group, the fenofibrate add-on therapy group had a better transplant-free survivals of 5 (89.7 vs 75.3%) and 10 years (87.0 vs 47.6%), with a hazard ratio of 0.3282 (95% confidence interval: 0.1334-0.8073, P < 0.05). Twenty-one cases (25.6%) developed adverse events, with liver injury being the most frequent one (17.1%).
CONCLUSION: Fenofibrate add-on therapy improved not only biochemical responses but also long-term transplant-free survival in PBC patients with suboptimal response to UDCA. However, liver injury needs to be closely monitored and properly managed.
Предметные рубрики MeSH
HumansFenofibrateFemaleLiver Cirrhosis, BiliaryRetrospective StudiesUrsodeoxycholic AcidMiddle AgedDrug Therapy, CombinationMaleCholagogues and CholereticsLiver TransplantationAlkaline Phosphatasegamma-GlutamyltransferaseAgedProspective StudiesTreatment OutcomeBiomarkersTime FactorsAdultHypolipidemic Agents