Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.
Department of Community Medicine and Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka, Japan.
Diabetes Obes Metab. 2019 Jul;21(7):1737-1744. doi: 10.1111/dom.13686. Epub 2019 Apr 1.
The aim of this study was to evaluate the efficacy and safety of pemafibrate in people with type 2 diabetes and hypertriglyceridaemia over a 52-week period. Participants were randomly assigned to receive treatment with placebo or pemafibrate at a dose of 0.2 or 0.4 mg/d for 24 weeks (treatment period 1). The main results from treatment period 1 have been reported previously. The assigned treatment was continued up to week 52, except that the placebo was changed to pemafibrate 0.2 mg/d after week 24 (treatment period 2). The percentage changes in fasting serum triglyceride (TG) levels at week 52 (last observation carried forward) were -48.2%, -42.3%, and -46.4% in the placebo/pemafibrate 0.2 mg/d (n = 57), pemafibrate 0.2 mg/d (n = 54), and pemafibrate 0.4 mg/d (n = 55) groups, respectively. Levels of TG, non-HDL cholesterol and total cholesterol stably decreased, whereas levels of HDL cholesterol increased with pemafibrate treatments over 52 weeks. Pemafibrate was well tolerated throughout the study period. The present study is the first to show that pemafibrate treatment substantially ameliorated lipid abnormalities and was well tolerated for 52 weeks in people with type 2 diabetes and hypertriglyceridaemia.
这项研究的目的是评估匹伐他汀在 52 周内治疗 2 型糖尿病伴高甘油三酯血症患者的疗效和安全性。参与者被随机分配接受安慰剂或匹伐他汀治疗，剂量分别为 0.2 或 0.4mg/d，持续 24 周（治疗期 1）。治疗期 1 的主要结果先前已报道过。在治疗期 1 中，除了在第 24 周后将安慰剂改为 0.2mg/d 的匹伐他汀外，继续使用分配的治疗方案至第 52 周（治疗期 2）。第 52 周（最后一次观测结转）空腹血清甘油三酯（TG）水平的百分比变化分别为安慰剂/匹伐他汀 0.2mg/d 组（n=57）-48.2%、匹伐他汀 0.2mg/d 组（n=54）-42.3%和匹伐他汀 0.4mg/d 组（n=55）-46.4%。在 52 周的匹伐他汀治疗期间，TG、非高密度脂蛋白胆固醇和总胆固醇水平稳定下降，而高密度脂蛋白胆固醇水平升高。在整个研究期间，匹伐他汀均耐受良好。本研究首次表明，匹伐他汀治疗可显著改善血脂异常，在 2 型糖尿病伴高甘油三酯血症患者中耐受良好 52 周。
