Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
Original Article
Evaluation of Pemafibrate Treatment in Improving Liver Function and Lipid Profiles in Patients with Steatotic Liver Disease: Case Series Study
Tomoki FURUYAShinji KITAHAMASusumu OGAWAYuma TAMURATakanori YASU
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2025 Volume 56 Issue 3 Pages 142-148

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Abstract

Background: The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) has tripled over the past 20 years. However, effective treatments for MASLD and MASH other than diet, exercise, pioglitazone, and tocopherol nicotinate are lacking. This single-arm study investigated the effects of pemafibrate treatment on lipid levels, liver function, diabetes, and weight-related changes in patients with steatotic liver disease.

Methods: Lipid-, liver function-, diabetes-, and weight-related changes before and after pemafibrate administration over 12-14 months were retrospectively analyzed in 38 patients diagnosed with hypertension and concomitant liver dysfunction.

Results: Pemafibrate treatment significantly reduced the levels of alanine aminotransferase, aspartate aminotransferase, γ-glutamyl transpeptidase, triglycerides, and low-density lipoprotein cholesterol. Furthermore, high-density lipoprotein cholesterol levels were slightly increased in men but remained unchanged in women. Nevertheless, hemoglobin A1c levels and body weight remained unchanged in both men and women. After 12-14 months of pemafibrate administration, AST (U/L) significantly decreased from 35 ± 15 to 27 ± 9 (p < 0.01), and ALT (U/L) decreased from 49 ± 29 to 26 ± 16 (p < 0.001). γ-GTP (U/L) was reduced from 73 ± 36 to 43 ± 23 (p < 0.001). Triglycerides (mg/dL) decreased from 263 ± 112 to 145 ± 94 (p < 0.001). HDL-C (mg/dL) increased from 52 ± 13 to 57 ± 15 (p < 0.001), and LDL-C (mg/dL) decreased from 117 ± 2 to 99 ± 25 (p < 0.001), all showing statistically significant differences. In contrast, HbA1c (%) showed no significant change, going from 6.9 ± 0.9 to 6.7 ± 0.7 (p = 0.24), and body weight (kg) remained stable at 74.5 ± 17.8 to 73.6 ± 18.2 (p = 0.84).

Conclusion: These findings suggest that pemafibrate may have potential therapeutic benefits for MASLD and MASH.

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© The Japanese Society of Clinical Pharmacology and Therapeutics
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