JPRN-jRCTs071200011已完成未知
Pemafibrate Reduction of TG-rich lipoproteins compared with Omega-3 fatty acid ethyl for Unmet needs in Dyslipidemic patients on target to ApoB48 - PROUD48
Takeda Yasutaka0 个研究点目标入组 129 人开始时间: 2020年4月28日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
The rate of change in fasting apoB48 from baseline to week 16 in pemafibrate treated group and omega-3 fatty acid ethyl were -50.8%(IQR-62.9,-30.3) and -17.5%(IQR -38.3, 15.3) (p<0.001),respectively. We concluded that pemafibrate was superior to omega-3 fatty acid ethyl in lowering effect of fasting apo B48.Pemafibrate is expected to reduce the residual risk for atherosclerotic cardiovascular disease with statin treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1)Patients who are 20 years old or older and 79 years old
- •2)Patients who have been taking statin for more than 4 weeks
- •3)Patients with fasting TG levels of 177 mg/dL (2 mmol/L) or higher
- •4)Patients who showed written consent form
排除标准
- •1)Patients with fasting TG levels of 500 mg/dL (5.7 mmol/L) or higher
- •2)Diabetic patients who showed HbA1c levels of 9 % or higher and who need glycemic control with insulin treatment
- •3)Patients with type 1 diabetes
- •4)Patients who showed moderate renal dysfunction (serum creatinine levels 1.5 mg/dL or higher)
- •5)Patients who used fibrates and nicotinic acids within 4 weeks
- •6)Patients who used omega-3 fatty acids and ethyl icosapentate and the supplements that contained same ingredients within 24 weeks
- •7)Patients with symptomatic cardiovascular and cerebrovascular disorders
- •8)Patients with severe infections
- •9)Patients with acute hepatitis or liver cirrhosis
- •10)Patients with cancer
- •11)Patients before or after surgery
- •12)Women with pregnancy or during breastfeeding
- •13)Patients who need lipid management with PCSK9 inhibitors or MTP inhibitors
- •14)Others. Patients who have contraindications to pemafibrate and omega-3 fatty acids
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