Seko Yuya, Yamaguchi Kanji, Umemura Atsushi, Yano Kota, Takahashi Aya, Okishio Shinya, Kataoka Seita, Okuda Keiichiroh, Moriguchi Michihisa, Okanoue Takeshi, Itoh Yoshito
Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Osaka, Japan.
Hepatol Res. 2020 Dec;50(12):1328-1336. doi: 10.1111/hepr.13571. Epub 2020 Oct 1.
Dyslipidemia (DL) is commonly associated with non-alcoholic 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.
Twenty NAFLD patients with DL who received pemafibrate (0.1 mg) twice a day for 12 weeks were prospectively enrolled in this study. The primary end-point was change in serum alanine aminotransferase (ALT) levels from baseline to week 12.
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, high-density lipoprotein 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 polyunsaturated / saturated fatty acid ratio (PUFA / SFA ratio) at baseline were correlated with change in ALT level (r = -0.53, r = -0.57, and r = 0.46, respectively). Change in PUFA and change in PUFA / SFA ratio were negatively correlated with change in ALT level (r = -0.49 and r = -0.53). No hepatic or renal adverse events were reported.
Selective peroxisome proliferator activated receptor α could be a promising novel agent for treatment of NAFLD patients with DL by regulating fatty acid composition. A further long-term large-scale trial is warranted to confirm the efficacy of SPPARMα on NAFLD with DL.
血脂异常（DL）通常与非酒精性脂肪性肝病（NAFLD）相关。匹伐他汀，一种选择性过氧化物酶体增殖物激活受体α调节剂（SPPARMα），已被证明可改善DL患者的肝功能。这项单臂前瞻性研究的目的是评估匹伐他汀在患有DL的NAFLD患者中的疗效。
本研究前瞻性纳入了20例患有DL的NAFLD患者，他们接受匹伐他汀（0.1毫克）每日两次，共12周。主要终点是血清丙氨酸氨基转移酶（ALT）水平从基线到第12周的变化。
血清ALT水平从基线时的75.1 IU/L降至第12周时的43.6 IU/L（P = 0.001）。甘油三酯、高密度脂蛋白胆固醇、总脂肪酸、饱和脂肪酸（SFA）和不饱和脂肪酸也有显著改善。基线时残留样蛋白胆固醇、SFA和多不饱和/饱和脂肪酸比值（PUFA/SFA比值）的血清水平与ALT水平的变化相关（分别为r = -0.53、r = -0.57和r = 0.46）。PUFA的变化和PUFA/SFA比值的变化与ALT水平的变化呈负相关（r = -0.49和r = -0.53）。未报告肝脏或肾脏不良事件。
选择性过氧化物酶体增殖物激活受体α可能是通过调节脂肪酸组成治疗患有DL的NAFLD患者的一种有前景的新型药物。需要进一步进行长期大规模试验以证实SPPARMα对伴有DL的NAFLD的疗效。
