Abstract
BACKGROUND: Metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) are prevalent conditions linked to obesity and metabolic disturbances, with potential complications such as cirrhosis and cardiovascular risks. This systematic review and meta-analysis aimed to evaluate the efficacy of pemafibrate, a drug targeting fat and sugar metabolism genes, in treating patients with MASLD/MASH. METHODS: Databases such as MEDLINE, Web of Science, Cochrane Library, and Scopus were searched until September 2023 to identify relevant studies. Selected studies underwent a thorough quality assessment using tools like Risk of Bias 2 tool (ROB-2) and the National Institutes of Health (NIH) Quality Assessment Tools. Comprehensive meta-analysis software was used for statistical evaluations, with a focus on lipid profiles, liver function tests, and fibrosis measurements. RESULTS: A total of 13 studies were included; 10 of them were included in the quantitative analysis. Our findings showed that pemafibrate significantly decreased low-density lipoprotein cholesterol (LDL-C) (effect size (ES) = -9.61 mg/dL, 95% confidence interval (CI): -14.15 to -5.08), increased high-density lipoprotein cholesterol (HDL-C) (ES = 3.15 mg/dL, 95% CI: 1.53 to 4.78), and reduced triglycerides (TG) (ES = -85.98 mg/dL, 95% CI: -96.61 to -75.36). Additionally, pemafibrate showed a marked reduction in liver enzyme levels, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), γ-glutamyl transpeptidase (GGT), and alkaline phosphatase (ALP), with significant effect sizes and P values. For liver stiffness outcomes, pemafibrate decreased AST to platelet ratio index (APRI) (ES = -0.180, 95% CI: -0.221 to -0.138). CONCLUSIONS: Pemafibrate, with its enhanced efficacy and safety profile, presents as a pivotal agent in MASLD/MASH treatment. Its lipid-regulating properties, coupled with its beneficial effects on liver inflammation markers, position it as a potentially invaluable therapeutic option.