PDF(Pubmed)
Abstract：
UNASSIGNED: This study aimed to clarify the efficacy and safety of 48-week pemafibrate treatment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated by dyslipidemia.
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.
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.
摘要：
■本研究旨在阐明对代谢功能障碍相关的脂肪变性肝病（MASLD）并发血脂异常患者进行48周倍贝特治疗的疗效和安全性。
■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。
■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。
