Efficacy and safety of statins for nonalcoholic/metabolic dysfunction-associated fatty liver diseases: a systematic review and meta-analysis

Expert Rev Clin Pharmacol. 2025 Dec;18(12):1095-1106. doi: 10.1080/17512433.2025.2600410. Epub 2025 Dec 11.

Abstract

Introduction: Nonalcoholic fatty liver diseases (NAFLD) and metabolic dysfunction-associated fatty liver diseases (MAFLD) are closely associated with metabolic syndrome, including obesity, dyslipidemia, and insulin resistance (IR). Thus, stains may be considered for the management of NAFLD/MAFLD. However, its efficacy and safety remain unclear in NAFLD/MAFLD.

Methods: The PubMed, EMBASE, and Cochrane library databases were searched to identify randomized controlled trials (RCTs) evaluating the efficacy and/or safety of statins in NAFLD/MAFLD. Risk ratios (RRs) and weight mean differences (WMDs) with their 95% confidence intervals (CIs) were calculated.

Results: Seven studies involving 993 patients with NAFLD/MAFLD were included. Statins were significantly associated with reductions in alanine aminotransferase (ALT, WMD = -9.76 U/L, 95%CI: -17.28, -2.24, p = 0.010), aspartate aminotransferase (AST, WMD = -4.46 U/L, 95%CI: -9.03, 0.11, p = 0.060), gamma-glutamyl-transpeptidase (GGT, WMD = -10.18 U/L, 95%CI: -13.65, -6.70, p < 0.001), low-density lipoprotein (LDL, WMD = -0.86 mmol/L, 95%CI: -1.06, -0.66, p < 0.001), total cholesterol (TC, WMD = -0.88 mmol/L, 95%CI: -1.14, -0.61, p < 0.001), and triglyceride (TG, WMD = -0.32 mmol/L, 95%CI: -0.45, -0.19, p < 0.001) levels. Additionally, statins did not increase the risk of myalgia (RR = 0.96, 95%CI: 0.10, 9.00, p = 0.970).

Conclusions: Statins could improve liver function and lipid profiles in NAFLD/MAFLD. No myalgia was reported as AEs in the studies we included and the overall safety was favorable.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42025630809.

Keywords: Statins; efficacy; metabolic dysfunction-associated fatty liver diseases; nonalcoholic fatty liver diseases; safety.

Publication types

  • Systematic Review
  • Meta-Analysis

MeSH terms

  • Dyslipidemias / complications
  • Dyslipidemias / drug therapy
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / pharmacology
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / therapeutic use
  • Insulin Resistance
  • Metabolic Syndrome / complications
  • Metabolic Syndrome / drug therapy
  • Non-alcoholic Fatty Liver Disease* / drug therapy
  • Non-alcoholic Fatty Liver Disease* / physiopathology
  • Randomized Controlled Trials as Topic

Substances

  • Hydroxymethylglutaryl-CoA Reductase Inhibitors