Kikuchi Masahiro, Kikuchi Miho, Konishi Masahiro
Hatanodai Hospital, Japan.
Tokai University School of Medicine, Division of Gastroenterology, Japan.
Clin Exp Hepatol. 2024 Sep;10(3):182-187. doi: 10.5114/ceh.2024.143072. Epub 2024 Sep 30.
Non-alcoholic fatty liver disease (NAFLD) is a pathological condition associated with inflammation owing to fat deposition in the liver. Managing hypertriglyceridemia is essential for patients with NAFLD, including treatment with pemafibrate. However, whether pemafibrate affects fat deposition in the liver and whether hypertriglyceridemia is the primary treatment target remain unclear. Thus, in this single-arm, retrospective study, we explored how pemafibrate treatment affects fat deposition in the liver in patients with NAFLD using FibroScan, the only insurance-covered device in Japan for quantitatively measuring fat in the liver.
Patients with NAFLD and hypertriglyceridemia were administered 0.2 mg/day of pemafibrate for either three ( = 51) or six ( = 42) months. The primary endpoint was the FibroScan (FibroScan 430 Mini, Echosens, France) controlled attenuation parameter (CAP) measurement. The secondary endpoints were liver transaminase levels, the FibroScan-aspartate aminotransferase (FAST) score, the hepatic steatosis index (HSI), the fibrosis-4 (FIB-4) index, the aspartate aminotransferase-to-platelet ratio index (APRI), and the albumin-bilirubin (ALBI) score.
Three months of pemafibrate administration significantly improved the CAP values. The FAST score and HSI also significantly improved after three months, suggesting fatty liver improvements. Furthermore, the alanine aminotransferase and γ-glutamyl transpeptidase levels (indicators of hepatitis) decreased, and fibrosis improved in the liver fibrosis prediction assessments, such as the FIB-4 index, APRI, and ALBI score, after three months of pemafibrate administration. Most of these improvements remained after six months.
Oral pemafibrate treatment improved NAFLD in patients with hypertriglyceridemia, indicating that pemafibrate may be a new treatment option for NAFLD.
非酒精性脂肪性肝病（NAFLD）是一种因肝脏脂肪沉积而伴有炎症的病理状态。对于NAFLD患者，控制高甘油三酯血症至关重要，包括使用匹伐他汀进行治疗。然而，匹伐他汀是否会影响肝脏脂肪沉积以及高甘油三酯血症是否为主要治疗靶点仍不明确。因此，在这项单臂回顾性研究中，我们使用FibroScan（日本唯一一项纳入医保的用于定量测量肝脏脂肪的设备），探讨了匹伐他汀治疗对NAFLD患者肝脏脂肪沉积的影响。
患有NAFLD和高甘油三酯血症的患者每天服用0.2mg匹伐他汀，疗程为3个月（n = 51）或6个月（n = 42）。主要终点是FibroScan（FibroScan 430 Mini，法国Echosens公司）控制衰减参数（CAP）测量值。次要终点包括肝转氨酶水平、FibroScan-天冬氨酸转氨酶（FAST）评分、肝脂肪变性指数（HSI）、纤维化-4（FIB-4）指数、天冬氨酸转氨酶与血小板比值指数（APRI）以及白蛋白-胆红素（ALBI）评分。
服用匹伐他汀3个月后，CAP值显著改善。3个月后，FAST评分和HSI也显著改善，提示脂肪肝有所改善。此外，服用匹伐他汀3个月后，丙氨酸转氨酶和γ-谷氨酰转肽酶水平（肝炎指标）下降，在肝脏纤维化预测评估中，如FIB-4指数、APRI和ALBI评分，纤维化情况有所改善。这些改善大多在6个月后仍持续存在。
口服匹伐他汀治疗改善了高甘油三酯血症患者的NAFLD，表明匹伐他汀可能是NAFLD的一种新治疗选择。
