作为 lipid-modifying 治疗的阿纳塞特拉皮布在患者的异构性家族高胆固醇血症 (REALIZE):一个随机,双盲,安慰剂控制的,第3期研究
John J P Kastelein1, Joost Besseling1, Sukrut Shah2
1Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Lancet (London, England)
|March 7, 2015
概括
在家族性高胆固醇血症患者中,阿纳塞特拉皮显著降低了LDL胆固醇. 需要进一步的研究来确认这是否会减少心血管事件.
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.
背景情况:
- 家族性高胆固醇血症 (FH) 需要低的LDL胆固醇 (LDL-C) 度.
- 目前的治疗方法往往无法在FH患者中达到目标的LDL-C水平.
- 胆固醇转移蛋白 (CETP) 抑制剂可以降低LDL-C,当与他类药物一起使用.
研究的目的:
- 评估CETP抑制剂阿纳塞特拉皮的安全性和有效性.
- 为了评估anacetrapib对LDL-C在异合性FH患者的影响.
主要方法:
- 一个多中心的,随机的,双盲的,安慰剂控制的,第三阶段研究.
- 18-80岁的异性FH患者接受了阿纳塞特拉皮布 (100毫克) 或安慰剂52周.
- 主要结局:LDL-C与基线的百分比变化.
主要成果:
- 与安慰剂相比,在52周内,阿纳塞特拉皮比降低了平均LDL-C的36.0%,与安慰剂相比.
- 在LDL-C降低中,阿纳塞特拉皮和安慰剂之间的差异为-39.7% (p<0.0001).
- 心血管事件在阿纳塞特拉皮布组略有增加,但不良事件发生率相似.
结论:
- 在异合性FH患者中,一年的Anacetrapib治疗耐受性良好.
- 在LDL-C度方面,Anacetrapib取得了显著的降低.
- 一项正在进行的结果研究将确定这些LDL-C减少是否转化为更少的心血管事件.
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