Abstract：
OBJECTIVE: No pharmacotherapeutic treatment has been established for metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH). This trial compared the effects of pemafibrate and omega-3-acid ethyl ester on hepatic function in patients with hypertriglyceridemia complicated by MASLD.
METHODS: Patients with hypertriglyceridemia complicated by MASLD were enrolled, randomly assigned to the pemafibrate or omega-3-acid ethyl ester group, and followed for 24 weeks. The primary endpoint was the change in alanine aminotransferase (ALT) from baseline to week 24. The secondary endpoints included other hepatic enzymes, lipid profiles, and hepatic fibrosis biomarkers.
RESULTS: A total of 80 patients were enrolled and randomized. The adjusted mean change in ALT from baseline to week 24 was significantly lower in the pemafibrate group (-19.7±5.9 U/L) than in the omega-3-acid ethyl ester group (6.8±5.5 U/L) (intergroup difference, -26.5 U/L; 95% confidence interval, -42.3 to -10.7 U/L; p=0.001). Pemafibrate significantly improved the levels of other hepatic enzymes (aspartate aminotransferase and gamma-glutamyl transpeptidase), lipid profiles (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol), and hepatic fibrosis biomarkers (Mac-2 binding protein glycan isomer and Fibrosis-4 index). No cases of discontinuation due to adverse drug reactions were identified in either group, and there were no safety concerns.
CONCLUSIONS: Pemafibrate is recommended over omega-3-acid ethyl ester for lipid management and MASLD treatment in patients with hypertriglyceridemia complicated by MASLD. The study results may contribute to the development of future treatment strategies for patients with MASLD/MASH.
METHODS: Patients with hypertriglyceridemia complicated by MASLD were enrolled, randomly assigned to the pemafibrate or omega-3-acid ethyl ester group, and followed for 24 weeks. The primary endpoint was the change in alanine aminotransferase (ALT) from baseline to week 24. The secondary endpoints included other hepatic enzymes, lipid profiles, and hepatic fibrosis biomarkers.
RESULTS: A total of 80 patients were enrolled and randomized. The adjusted mean change in ALT from baseline to week 24 was significantly lower in the pemafibrate group (-19.7±5.9 U/L) than in the omega-3-acid ethyl ester group (6.8±5.5 U/L) (intergroup difference, -26.5 U/L; 95% confidence interval, -42.3 to -10.7 U/L; p=0.001). Pemafibrate significantly improved the levels of other hepatic enzymes (aspartate aminotransferase and gamma-glutamyl transpeptidase), lipid profiles (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol), and hepatic fibrosis biomarkers (Mac-2 binding protein glycan isomer and Fibrosis-4 index). No cases of discontinuation due to adverse drug reactions were identified in either group, and there were no safety concerns.
CONCLUSIONS: Pemafibrate is recommended over omega-3-acid ethyl ester for lipid management and MASLD treatment in patients with hypertriglyceridemia complicated by MASLD. The study results may contribute to the development of future treatment strategies for patients with MASLD/MASH.
摘要：
目的：目前尚未建立代谢功能障碍相关脂肪性肝炎（MASLD）和代谢功能障碍相关脂肪性肝炎（MASH）的药物治疗方法。该试验比较了培美贝酯和ω-3-酸乙酯对高甘油三酯血症并发MASLD患者肝功能的影响。
方法：纳入合并MASLD的高甘油三酯血症患者，随机分配到pemaberate或omega-3-酸乙酯组，并随访24周。主要终点是丙氨酸转氨酶（ALT）从基线到第24周的变化。次要终点包括其他肝酶，脂质分布，和肝纤维化生物标志物。
结果：共纳入80例患者并随机分组。从基线到第24周，调整后的ALT平均变化在培贝特组（-19.7±5.9U/L）明显低于ω-3-酸乙酯组（6.8±5.5U/L）（组间差异，-26.5U/L；95%置信区间，-42.3至-10.7U/L；p=0.001）。培马贝特显著提高其他肝酶（天冬氨酸转氨酶和γ-谷氨酰转肽酶）的水平，脂质分布(甘油三酯，总胆固醇,高密度脂蛋白胆固醇，和非高密度脂蛋白胆固醇），和肝纤维化生物标志物（Mac-2结合蛋白聚糖异构体和纤维化-4指数）。两组均未发现因药物不良反应而停药的病例,也没有安全隐患.
结论：对于伴有MASLD的高甘油三酯血症患者，推荐使用Pemafravate优于omega-3-酸乙酯用于脂质管理和MASLD治疗。研究结果可能有助于MASLD/MASH患者未来治疗策略的发展。
方法：纳入合并MASLD的高甘油三酯血症患者，随机分配到pemaberate或omega-3-酸乙酯组，并随访24周。主要终点是丙氨酸转氨酶（ALT）从基线到第24周的变化。次要终点包括其他肝酶，脂质分布，和肝纤维化生物标志物。
结果：共纳入80例患者并随机分组。从基线到第24周，调整后的ALT平均变化在培贝特组（-19.7±5.9U/L）明显低于ω-3-酸乙酯组（6.8±5.5U/L）（组间差异，-26.5U/L；95%置信区间，-42.3至-10.7U/L；p=0.001）。培马贝特显著提高其他肝酶（天冬氨酸转氨酶和γ-谷氨酰转肽酶）的水平，脂质分布(甘油三酯，总胆固醇,高密度脂蛋白胆固醇，和非高密度脂蛋白胆固醇），和肝纤维化生物标志物（Mac-2结合蛋白聚糖异构体和纤维化-4指数）。两组均未发现因药物不良反应而停药的病例,也没有安全隐患.
结论：对于伴有MASLD的高甘油三酯血症患者，推荐使用Pemafravate优于omega-3-酸乙酯用于脂质管理和MASLD治疗。研究结果可能有助于MASLD/MASH患者未来治疗策略的发展。
