Effect of Pemafibrate on fatty acid levels and liver enzyme in NAFLD patients with Dyslipidemia: a single-arm, pilot study.

BACKGROUND Dyslipidemia (DL) is commonly associated with nonalcoholic fatty liver disease (NAFLD). Pemafibrate, a selective peroxisome proliferator activated receptor α modulator (SPPARMα), has been shown to improve liver function among patients with DL. The aim of this single-arm prospective study is to evaluate the efficacy of pemafibrate in NAFLD patients with DL. METHODS Twenty NAFLD patients with DL who received pemafibrate (0.1mg) twice a day for 12 weeks were prospectively enrolled in this study. The primary endpoint was change in serum alanine aminotransferase (ALT) levels from baseline to week 12. RESULTS Serum ALT levels decreased from 75.1 IU/L at baseline to 43.6 IU/L at week 12 (p=0.001). Significant improvements in triglyceride, HDL cholesterol, total fatty acid, saturated fatty acid (SFA), and unsaturated fatty acid were also noted. The serum level of remnant-like protein cholesterol, SFA and poly-saturated/saturated fatty acid ratio (PUFA/SFA ratio) at baseline were correlated with change in ALT level (r= -0.53, r= -0.57, r= 0.46, respectively). Change in PUFA and change in PUFA/SFA ratio were negatively correlated with change in ALT level (r= -0.49, r= -0.53). No hepatic or renal adverse events were reported. CONCLUSIONS SPPARMα may be a promising novel agent for treatment of NAFLD patients with DL via regulating fatty acid composition. A further long-term large-scale trial is warranted to confirm the efficacy of SPPARMα on NAFLD with DL.