OBJECTIVE Type 2 diabetes is frequently complicated with atherogenic dyslipidemia. This study aimed to evaluate the efficacy and safety of pemafibrate (K-877) in patients with type 2 diabetes comorbid with hypertriglyceridemia.

RESEARCH DESIGN AND METHODS Patients were randomly assigned to three groups and received placebo (n = 57), 0.2 mg/day pemafibrate (n = 54), or 0.4 mg/day pemafibrate (n = 55) for 24 weeks (treatment period 1). Subsequently, the patients received follow-up treatment for another 28 weeks (treatment period 2), in which the placebo was switched to 0.2 mg/day pemafibrate. This article presents the results of treatment period 1, which were the primary objectives.

RESULTS The pemafibrate groups showed significantly reduced fasting serum triglyceride levels by ∼45% compared with the placebo group (P < 0.001). Additionally, the pemafibrate groups displayed significant decreases in non-HDL and remnant lipoprotein cholesterol, apolipoprotein (Apo) B100, ApoB48, and ApoCIII levels and significant increases in HDL cholesterol and ApoA-I levels. LDL cholesterol levels were not considerably altered in the pemafibrate groups. Furthermore, the 0.2 mg/day pemafibrate group showed a significantly reduced HOMA–insulin resistance score compared with the placebo group; however, no significant changes compared with placebo were found in fasting plasma glucose, fasting insulin, glycoalbumin, or HbA_1c levels. The pemafibrate groups also showed significantly increased fibroblast growth factor 21 levels compared with the placebo group. All groups displayed comparable rates of adverse events and drug reactions.

CONCLUSIONS Pemafibrate significantly ameliorated lipid abnormalities and was well tolerated in patients with type 2 diabetes comorbid with hypertriglyceridemia.

目的2型糖尿病经常并发动脉粥样硬化性血脂异常。这项研究的目的是评估匹马贝特（K-877）在合并高甘油三酯血症的2型糖尿病患者中的疗效和安全性。

研究设计与方法将患者随机分为三组，分别接受安慰剂（n = 57），0.2 mg /天的哌马贝特（n = 54）或0.4 mg /天的pemafibrate（n = 55），为期24周（治疗期1）。 。随后，患者接受了另外28周的随访治疗（治疗期2），其中安慰剂改为0.2 mg / day哌马贝特。本文介绍了治疗期1的结果，这是主要目标。

结果与安慰剂组相比，马来酸贝特组的空腹血清甘油三酯水平显着降低了约45％（P <0.001）。此外，肺纤维化组的非HDL和残余脂蛋白胆固醇，载脂蛋白（Apo）B100，ApoB48和ApoCIII水平显着降低，而HDL胆固醇和ApoA-I水平显着升高。在肺纤维化组中，LDL胆固醇水平没有明显改变。此外，与安慰剂组相比，0.2 mg /天的哌马贝特组显示HOMA-胰岛素抵抗评分显着降低。但是，空腹血糖，空腹胰岛素，糖蛋白或HbA _1c与安慰剂相比无明显变化水平。与安慰剂组相比，pemfibrate组还显示出成纤维细胞生长因子21水平显着增加。所有组的不良事件和药物反应率均相当。

结论在2型糖尿病合并高甘油三酯血症的患者中，马来酸贝特明显改善了血脂异常，并具有良好的耐受性。