在患有高心血管风险的患者中,Olezarsen用于过高甘油三血症
Brian A Bergmark1, Nicholas A Marston1, Thomas A Prohaska1
1From the TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston (B.A.B., N.A.M., A.Z., F.A.M., S.A.M., E.L.G., S.Z., R.P.G., M.S.S.); Ionis Pharmaceuticals, Carlsbad (T.A.P., V.J.A., E.K.-P., S.T.), and the Division of Cardiovascular Medicine, Department of Medicine, University of California, San Diego, La Jolla (S.T.) - both in California; and the Department of Medicine, Université de Montréal and Ecogene-21 Clinical Research Centre, Quebec, QC, Canada (D.G.).
在患有高甘油三血症的患者中,Olezarsen有效降低了甘油三和阿波利波蛋白C-III水平. 这项研究表明,显著降低甘油三,没有重大安全问题,解决未满足的临床需求.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
- 遗传学 遗传学 是一个
背景情况:
- 增加的甘油三和富含甘油三的脂蛋白代表了显著的未满足的临床需求.
- 脂蛋白C-III (APOC3) 是一个被验证的降低甘油三的基因标.
- 奥莱萨森是一种反感性寡核酸,旨在降低APOC3mRNA水平.
研究的目的:
- 为了评估olezarsen在中度或重度高甘油三血症的成年人中的疗效和安全性.
- 评估olezarsen对甘油三水平和其他脂质参数的影响.
主要方法:
- 一个2b期,随机,受控试验,涉及154名患有高甘油三血的成年人.
- 参与者被分配给每月一次的皮下olezarsen (50 mg或80 mg) 或安慰剂.
- 主要结局:从基线到6个月,甘油三水平的百分比变化.
主要成果:
- 与安慰剂相比,Olezarsen (50 mg和80 mg) 显著降低了甘油三水平,分别为49.3%和53.1%, (P<0.001).
- 这两种剂量都显著降低了APOC3,阿波利波蛋白B和非HDL胆固醇水平.
- 各组的不良事件和严重不良事件相似;没有发现重大安全问题.
结论:
- 在患有高甘油三血症的患者中,Olezarsen在降低甘油三,阿波利波蛋白B和非HDL胆固醇方面表现出显著的有效性.
- 治疗耐受性很好,没有发现重大安全问题.
- 奥莱扎森代表了管理高甘油三血症的有前途的治疗选择.
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