{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Sun W"],"funding":["Shandong Provincial Natural Science Foundation","National Key R&amp;D Program of China","National Key R&D Program of China","Natural Science Foundation of Shandong Province","Shandong Provincial Science Foundation for Youth Scholars","Shandong Provincial key research and development program for major scientific and technological innovation"],"pagination":["1149-1156"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12371309"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["77(9)"],"pubmed_abstract":["<h4>Objective</h4>The objective of this study was to evaluate and compare the risk of hepatotoxicity associated with the use of febuxostat and benzbromarone in patients with gout.<h4>Methods</h4>New users of febuxostat or benzbromarone with monitoring of liver function at least three times in a year after initiation of the study drugs were identified from an electronic medical record database. Propensity score matching (PSM) was performed between the two groups 1:1 matched for age, sex, and pretreatment alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Kaplan-Meier analysis was used to estimate the probability of hepatotoxicity (defined as ALT or AST > 3× upper limit of normal). Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox regression. Subgroup analysis was performed based on age, body mass index, and comorbidities.<h4>Results</h4>A total of 2,338 patients with gout were eligible. A total of 37% of patients experienced Common Terminology Criteria for Adverse Events version 5 grades 1 to 3 for AST or ALT abnormality. After PSM, 488 febuxostat users were matched, with 488 participants receiving benzbromarone with a mean follow-up of 1.20 years. The incidence of hepatotoxicity was 39.6 and 16.8 per 1,000 person-years for febuxostat users and benzbromarone users, respectively. Febuxostat use was associated with a significantly greater risk of hepatotoxicity than benzbromarone (adjusted HR 2.75, 95% CI 1.28-5.91), especially in patients with elevated transaminases at baseline. Findings did not differ according to prespecified subgroups.<h4>Conclusion</h4>Febuxostat use is associated with a significantly greater risk of mild-to-moderate perturbation of liver function compared to benzbromarone in patients with gout."],"journal":["Arthritis care & research"],"pubmed_title":["Risk of Hepatotoxicity in Patients With Gout Treated With Febuxostat or Benzbromarone: A Propensity Score-Matched Cohort Study."],"pmcid":["PMC12371309"],"funding_grant_id":["2021ZDSYS06","#2022YFE0107600","ZR2023MH213","2021CXGC011103","#2022YFC2503300","ZR2023QH147"],"pubmed_authors":["Li X","Dalbeth N","Li C","Cui L","Terkeltaub R","Chen Y","Sun W","Liu T","Cheng X"],"additional_accession":[]},"is_claimable":false,"name":"Risk of Hepatotoxicity in Patients With Gout Treated With Febuxostat or Benzbromarone: A Propensity Score-Matched Cohort Study.","description":"<h4>Objective</h4>The objective of this study was to evaluate and compare the risk of hepatotoxicity associated with the use of febuxostat and benzbromarone in patients with gout.<h4>Methods</h4>New users of febuxostat or benzbromarone with monitoring of liver function at least three times in a year after initiation of the study drugs were identified from an electronic medical record database. Propensity score matching (PSM) was performed between the two groups 1:1 matched for age, sex, and pretreatment alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Kaplan-Meier analysis was used to estimate the probability of hepatotoxicity (defined as ALT or AST > 3× upper limit of normal). Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using Cox regression. Subgroup analysis was performed based on age, body mass index, and comorbidities.<h4>Results</h4>A total of 2,338 patients with gout were eligible. A total of 37% of patients experienced Common Terminology Criteria for Adverse Events version 5 grades 1 to 3 for AST or ALT abnormality. After PSM, 488 febuxostat users were matched, with 488 participants receiving benzbromarone with a mean follow-up of 1.20 years. The incidence of hepatotoxicity was 39.6 and 16.8 per 1,000 person-years for febuxostat users and benzbromarone users, respectively. Febuxostat use was associated with a significantly greater risk of hepatotoxicity than benzbromarone (adjusted HR 2.75, 95% CI 1.28-5.91), especially in patients with elevated transaminases at baseline. Findings did not differ according to prespecified subgroups.<h4>Conclusion</h4>Febuxostat use is associated with a significantly greater risk of mild-to-moderate perturbation of liver function compared to benzbromarone in patients with gout.","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Sep","modification":"2026-05-09T10:46:21.944Z","creation":"2026-04-08T00:48:45.302Z"},"accession":"S-EPMC12371309","cross_references":{"pubmed":["40195679"],"doi":["10.1002/acr.25547"]}}