Abstract：
OBJECTIVE: Pemafibrate substantially lowers serum triglyceride (TG) levels and increases high-density lipoprotein cholesterol (HDL-C) levels primarily in Japan, but it has not been evaluated in China. We aimed to confirm the efficacy and safety of pemafibrate in Chinese patients with hypertriglyceridemia and low HDL-C levels by comparing placebo and fenofibrate.
METHODS: A multicenter, double-masked trial was conducted in China involving 344 patients with high TG and low HDL-C levels randomly assigned to one of four groups: pemafibrate 0.2 mg/d, pemafibrate 0.4 mg/d, fenofibrate 200 mg/d, or placebo for 12 weeks. The primary endpoint was the percentage change in fasting TG levels.
RESULTS: The percentage change in TG levels from baseline was -34.1%, -44.0%, -30.5%, and 6.5% in the pemafibrate 0.2 mg/d, pemafibrate 0.4 mg/d, fenofibrate 200 mg/d, and placebo groups, respectively. Pemafibrate 0.4 mg/d significantly reduced TG levels compared with that in both placebo (p＜0.0001) and fenofibrate groups (p=0.0083). Significant improvements in HDL-C, remnant cholesterol, and apolipoprotein A1 levels were also observed with both doses of pemafibrate than with the placebo. Pemafibrate showed significantly smaller changes in alanine aminotransferase, aspartate aminotransferase, and serum creatinine levels than those with fenofibrate.
CONCLUSIONS: In Chinese patients, pemafibrate exhibited superior efficacy in improving TG levels and enhanced hepatic and renal safety compared to fenofibrate. Thus, pemafibrate may represent a promising therapeutic option for dyslipidemia in Chinese patients.
METHODS: A multicenter, double-masked trial was conducted in China involving 344 patients with high TG and low HDL-C levels randomly assigned to one of four groups: pemafibrate 0.2 mg/d, pemafibrate 0.4 mg/d, fenofibrate 200 mg/d, or placebo for 12 weeks. The primary endpoint was the percentage change in fasting TG levels.
RESULTS: The percentage change in TG levels from baseline was -34.1%, -44.0%, -30.5%, and 6.5% in the pemafibrate 0.2 mg/d, pemafibrate 0.4 mg/d, fenofibrate 200 mg/d, and placebo groups, respectively. Pemafibrate 0.4 mg/d significantly reduced TG levels compared with that in both placebo (p＜0.0001) and fenofibrate groups (p=0.0083). Significant improvements in HDL-C, remnant cholesterol, and apolipoprotein A1 levels were also observed with both doses of pemafibrate than with the placebo. Pemafibrate showed significantly smaller changes in alanine aminotransferase, aspartate aminotransferase, and serum creatinine levels than those with fenofibrate.
CONCLUSIONS: In Chinese patients, pemafibrate exhibited superior efficacy in improving TG levels and enhanced hepatic and renal safety compared to fenofibrate. Thus, pemafibrate may represent a promising therapeutic option for dyslipidemia in Chinese patients.
摘要：
目的：培巴贝特主要在日本显著降低血清甘油三酯（TG）水平和增加高密度脂蛋白胆固醇（HDL-C）水平，但在中国还没有评估过。我们的目的是通过比较安慰剂和非诺贝特，证实培马贝特在中国高甘油三酯血症和低HDL-C患者中的疗效和安全性。
方法：多中心，在中国进行了双掩蔽试验，涉及344例TG高和HDL-C低的患者，随机分为四组：pemaberate0.2mg/d，匹马贝特0.4毫克/天，非诺贝特200毫克/天，或安慰剂12周。主要终点是空腹TG水平的百分比变化。
结果：TG水平相对于基线的百分比变化为-34.1％，-44.0%，-30.5%,和6.5％的苯马贝特0.2毫克/天，匹马贝特0.4毫克/天，非诺贝特200毫克/天，和安慰剂组，分别。与安慰剂组(p＜0.0001)和非诺贝特组(p=0.0083)相比，培马贝特0.4mg/d显著降低TG水平。HDL-C的显著改进，残余胆固醇，和载脂蛋白A1水平也观察到与安慰剂相比，这两种剂量的培美贝贝特。培马贝特显示丙氨酸氨基转移酶的变化明显较小，天冬氨酸转氨酶,血清肌酐水平高于非诺贝特。
结论：在中国患者中，与非诺贝特相比，培马贝特在改善TG水平和增强肝肾安全性方面表现出优异的疗效。因此，匹马贝特可能是中国患者血脂异常的有希望的治疗选择。
方法：多中心，在中国进行了双掩蔽试验，涉及344例TG高和HDL-C低的患者，随机分为四组：pemaberate0.2mg/d，匹马贝特0.4毫克/天，非诺贝特200毫克/天，或安慰剂12周。主要终点是空腹TG水平的百分比变化。
结果：TG水平相对于基线的百分比变化为-34.1％，-44.0%，-30.5%,和6.5％的苯马贝特0.2毫克/天，匹马贝特0.4毫克/天，非诺贝特200毫克/天，和安慰剂组，分别。与安慰剂组(p＜0.0001)和非诺贝特组(p=0.0083)相比，培马贝特0.4mg/d显著降低TG水平。HDL-C的显著改进，残余胆固醇，和载脂蛋白A1水平也观察到与安慰剂相比，这两种剂量的培美贝贝特。培马贝特显示丙氨酸氨基转移酶的变化明显较小，天冬氨酸转氨酶,血清肌酐水平高于非诺贝特。
结论：在中国患者中，与非诺贝特相比，培马贝特在改善TG水平和增强肝肾安全性方面表现出优异的疗效。因此，匹马贝特可能是中国患者血脂异常的有希望的治疗选择。
