S S Sutton1,2, Joseph Magagnoli3,4, Tammy H Cummings2, James W Hardin2,5. 1. Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina College of Pharmacy, 715 Sumter Street, Columbia, SC, 29208, USA. 2. Dorn Research Institute, WJB Dorn Veterans Affairs Medical Center, Columbia, SC, USA. 3. Department of Clinical Pharmacy and Outcomes Sciences, University of South Carolina College of Pharmacy, 715 Sumter Street, Columbia, SC, 29208, USA. magagnol@mailbox.sc.edu. 4. Dorn Research Institute, WJB Dorn Veterans Affairs Medical Center, Columbia, SC, USA. magagnol@mailbox.sc.edu. 5. Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USA.
Abstract
OBJECTIVE: We sought to evaluate the relationship between acute liver injury (ALI) and statins utilizing the Veterans Affairs Informatics and Computing Infrastructure (VINCI) database. METHODS: This retrospective cohort study, spanning January 2000-December 2018, compared ALI (aminotransferase > 200 U/L, severe ALI, and hospitalization with ALI) in statin users and non-users among uninfected, hepatitis C virus (HCV) mono-infected, human immunodeficiency virus (HIV)/HCV co-infected, and HIV mono-infected veterans within 18 months. We estimated adjusted Cox proportional hazards models comparing statin users and non-users and comparing statin intensity level with non-use; and estimate Cox proportional hazards models utilizing time-dependent coding of statin intensity. Adjusted models included restricted cubic splines of the propensity score as an adjustment variable. RESULTS: From a total of 166,439 patients who met the study criteria, statin initiators were older, had higher values of body mass index, higher values of low-density lipoprotein cholesterol and triglycerides, and lower values of high-density lipoprotein cholesterol. HCV mono-infected and HIV/HCV co-infected cohorts had the highest rates of ALI, and statin users had lower rates across all outcomes of ALI compared with non-users in unadjusted analysis. Statin use is associated with a lower risk of all ALI outcomes compared with non-users. Patients on a high intensity are not associated with a statistically significant increase in risk for any ALI outcome. For each additional 30 days of treatment, there was a reduced risk of any ALI outcome across all cohorts. CONCLUSIONS: Statin initiators had a lower risk of any ALI outcome compared with non-users within 18 months regardless of HIV and/or HCV status.
OBJECTIVE: We sought to evaluate the relationship between acute liver injury (ALI) and statins utilizing the Veterans Affairs Informatics and Computing Infrastructure (VINCI) database. METHODS: This retrospective cohort study, spanning January 2000-December 2018, compared ALI (aminotransferase > 200 U/L, severe ALI, and hospitalization with ALI) in statin users and non-users among uninfected, hepatitis C virus (HCV) mono-infected, human immunodeficiency virus (HIV)/HCV co-infected, and HIV mono-infected veterans within 18 months. We estimated adjusted Cox proportional hazards models comparing statin users and non-users and comparing statin intensity level with non-use; and estimate Cox proportional hazards models utilizing time-dependent coding of statin intensity. Adjusted models included restricted cubic splines of the propensity score as an adjustment variable. RESULTS: From a total of 166,439 patients who met the study criteria, statin initiators were older, had higher values of body mass index, higher values of low-density lipoprotein cholesterol and triglycerides, and lower values of high-density lipoprotein cholesterol. HCV mono-infected and HIV/HCV co-infected cohorts had the highest rates of ALI, and statin users had lower rates across all outcomes of ALI compared with non-users in unadjusted analysis. Statin use is associated with a lower risk of all ALI outcomes compared with non-users. Patients on a high intensity are not associated with a statistically significant increase in risk for any ALI outcome. For each additional 30 days of treatment, there was a reduced risk of any ALI outcome across all cohorts. CONCLUSIONS: Statin initiators had a lower risk of any ALI outcome compared with non-users within 18 months regardless of HIV and/or HCV status.
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