EXPRESS: Association of Statins with Onset and Progression of Non-Alcoholic Fatty Liver Disease in Patients with Diabetes.

Non-alcoholic fatty liver disease (NAFLD) is the commonest cause of chronic liver disease in patients with diabetes; limited data suggested that statins may reduce the risk of NAFLD progression. This study aimed to examine the association between statins and the development or progression of NAFLD in veterans with diabetes. In a new-user negative control design, we conducted a retrospective propensity-score (PS) matched cohort study of patients with diabetes between 2003 and 2015. After excluding patients with other causes of liver disease, we formed PS using 85 characteristics. The primary outcome was a composite NAFLD progression outcome. Primary analysis examined odds of outcome in PS matched cohort. Post-hoc analysis included PS-matched cohort of statin users with intensive lowering of LDL-cholesterol versus low-intensity lowering. We matched 34,102 pairs from 300,739 statin users and 38,038 non-users. The composite outcome occurred in 8.8% of statin users and 8.6% of non-users (odds ratio [OR]: 1.02; 95% confidence interval [95%CI]: 0.97-1.08). In the post-hoc analysis, intensive lowering of LDL-cholesterol compared to low-intensity showed increased NAFLD progression (OR: 1.21, 95%CI: 1.13-1.30). This study showed that statin use in patients with diabetes was not associated with decreased or increased risk of NAFLD progression. Intensive LDL-cholesterol lowering compared to low-intensity LDL-cholesterol lowering was associated with an increased risk of NAFLD progression.