JPRN-UMIN000047737已完成未知
Efficacy and safety of pemafibrate in high risk patients with coronary artery disease - PEBE Trial
Department of Cardiology, Iwate Prefectural Centgral Hospital0 个研究点目标入组 60 人开始时间: 2022年5月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
The %Change in TG and Apo A-I levels was significantly greater with pemafibrate than with bezafibrate (-46.1% vs. -34.7%, p<0.001; 9.2% vs. 5.7%, p=0.018, respectively). %Change in HDL-C levels was not significantly different between the two treatments. %Change in liver enzyme levels was markedly decreased with pemafibrate than with bezafibrate.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.patients who required additional medication for dyslipidemia during the study period 2.fasting serum TG levels of over than 1000 mg/dl 3.type 1 diabetes mellitus or uncontrolled type 2 DM (HbA1c level of over than 8.5%) 4.familiar hypercholesterolemia 5.chronic kidney disease showing a serum creatinine level of over than 1.5 mg/dL 6.history or complication of gallbladder disease, cholelithiasis, pancreatitis, and malignant tumor 7.aspartate aminotransferase (AST) or alanine aminotransferase (ALT) elevation to a level more than two times the upper limit of normal (ULN) range 8.uncontrolled hypertension (systolic blood pressure BP ofover tahn 160 mmHg or diastolic BP of over than 100 mmHg) 9.hemoglobin level of less than 12g/dL in men or less than 11 g/dL in women 11.recent myocardial infarction or cerebrovascular disorder within 3 months before the study 12.hospitalization for worsening heart failure within 3 months 13.use of ezetimibe and supplements containing eicosapentaenoic acid, and/or docosahexaenoic acid within 3 months before the study. Patients were also prohibited from using agents that affect lipid metabolism,such as thiazolidinedione, insulin,oral corticosteroid, or protease inhibitor.
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