UNASSIGNED: A total of 110 patients diagnosed with MASLD complicated by dyslipidemia received pemafibrate at a dose of 0.1 mg twice daily for 48 weeks.
UNASSIGNED: The participants were 54 males and 37 females, with a median age of 63 (52-71) years. Besides improvement in lipid profile, significant reductions from baseline to 48 weeks of treatment were found in liver-related enzymes, such as aspartate aminotransferase, alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, and alkaline phosphatase (P < 0.001 for all). A significant decrease in the homeostasis model assessment-insulin resistance (HOMA-IR) was observed in patients with insulin resistance (HOMA-IR ≥ 2.5) (4.34 at baseline to 3.89 at Week 48, P < 0.05). Moreover, changes in ALT were weakly correlated with those in HOMA-IR (r = 0.34; p < 0.05). Regarding noninvasive liver fibrosis tests, platelets, Wisteria floribunda agglutinin-positive Mac-2-binding protein, type IV collagen 7s, and the non-alcoholic fatty liver disease fibrosis score significantly decreased from baseline to Week 48. Most adverse events were Grades 1-2, and no drug-related Grade 3 or higher adverse events were observed.
UNASSIGNED: This study demonstrated that 48-week pemafibrate administration improved liver-related enzymes and surrogate marker of liver fibrosis in patients with MASLD. The improvement of insulin resistance by pemafibrate may contribute to the favorable effect on MASLD complicated by dyslipidemia.
■共有110例诊断为MASLD并伴有血脂异常的患者接受了倍贝特,剂量为0.1mg,每天两次,持续48周。
■参与者是54名男性和37名女性,年龄中位数为63(52-71)岁。除了改善血脂,从基线到治疗48周,肝脏相关酶显著减少,如天冬氨酸氨基转移酶,丙氨酸氨基转移酶(ALT),γ-谷氨酰转肽酶,碱性磷酸酶(P<0.001)。在具有胰岛素抵抗(HOMA-IR≥2.5)的患者中观察到稳态模型评估-胰岛素抵抗(HOMA-IR)的显着降低(基线时4.34至第48周的3.89,P<0.05)。此外,ALT的变化与HOMA-IR的变化弱相关(r=0.34;p<0.05)。关于非侵入性肝纤维化测试,血小板,紫藤凝集素阳性Mac-2结合蛋白,IV型胶原蛋白7s,非酒精性脂肪性肝病纤维化评分从基线至第48周显著降低。大多数不良事件为1-2级,没有观察到药物相关的3级或更高的不良事件。
■这项研究表明,在MASLD患者中,给药48周倍贝特可改善肝脏相关酶和肝纤维化的替代标志物。倍贝特改善胰岛素抵抗可能有助于改善MASLD并发血脂异常。