Background and aims: Statin is often under-prescribed in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) due to fear of hepatotoxicity. Limited studies examine the safety of statin in MASLD prospectively. We evaluated the safety of statins in a cohort with biopsy proven MASLD.
Methods: The study cohort comprised patients with biopsy proven MASLD between 2009 and 2022, with clinical data prospectively collected. We compared the liver profiles of patients with or without statins, at baseline and follow-up. We evaluated risk of statin-related hepatotoxicity in a subgroup of patients with advanced fibrosis or higher baseline transaminase elevation.
Results: There were 215 patients with biopsy proven MASLD, 115(53.5%) were female. The median age of all patients was 59.9 years. A total of 115(53.5%) patients received statins. Simvastatin and atorvastatin were most used (89.5%). NAFLD activity scores and fibrosis stage were similar between the two cohorts. Baseline ALT was higher in the non-statins' cohort (73 U/L vs 57.5 U/L, p < 0.01). The median duration of statins use was 63 months. At follow-up in comparison to baseline, ALT was significantly lower in both statins (57.5 U/L vs 45 U/L, p < 0.01), and non-statins cohort (73 U/L vs 43 U/L, p < 0.01). There was no significant difference in liver enzyme between the cohorts at follow-up. In subgroup of patients with advanced fibrosis, statins use was not associated with worsening of liver enzymes or liver stiffness.
Conclusions: In this cohort with biopsy proven MASLD, the use of statins was well tolerated and not associated with worsening liver enzymes or fibrosis.
Keywords: Deranged liver enzymes; Drug-induced liver injury; Hepatotoxicity; MASLD; Statins.
© 2026. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.