托塞特拉皮布和动脉内膜-介质厚度在混合性脂质失调症 (RADIANCE 2研究):一个随机的,双盲试验
Michiel L Bots1, Frank L Visseren2, Gregory W Evans3
1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands.
Lancet (London, England)
|July 17, 2007
概括
托塞特拉皮布在混合性失脂症患者中没有减缓动脉动脉样硬化进展,尽管提高了高密度胆固醇和降低了低密度胆固醇. 该药物增加了血压,并没有显示出临床益处,导致其中止.
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.
- 临床试验 临床试验
背景情况:
- 混合性脂质失调症的特点是高甘油三,低高达林蛋白和高LDL胆固醇.
- 抑制胆固醇转移蛋白 (CETP) 以增加高密度胆固醇可能有利于这些患者.
- 托塞特拉皮布是一种CETP抑制剂,研究其对动脉样硬化的作用.
研究的目的:
- 为了评估CETP抑制剂torcetrapib对心动脉动脉样硬化进展在患有混合性失脂血症的患者的影响.
- 评估torcetrapib与阿托瓦斯塔丁结合的影响,与单独的阿托瓦斯塔丁对内心介质厚度的影响.
主要方法:
- 一个随机的双盲试验,涉及752名患有混合性脂质失调症的患者.
- 参与者接受了阿托瓦斯塔丁与托塞特拉皮布 (n=377) 或安慰剂 (n=375) 合并24个月.
- 带超声波测量了6个月间隔内心介质厚度的变化.
主要成果:
- 托塞特拉皮显著增加了HDL胆固醇63.4%,降低了LDL胆固醇17.7%.
- 研究小组之间没有观察到动脉内心介质厚度进展率的显著差异 (-0.005毫米/年,p=0.46).
- 与安慰剂相比,torcetrapib显著增加了5.4mmHg的静脉压 (p<0.0001).与安慰剂相比,torcetrapib显著增加了5.4mmHg的静脉压 (p<0.0001).
结论:
- 托塞特拉皮布有效地改变了脂质样本,但没有减少动脉动脉样硬化的进展.
- 药物对血压的不良影响和缺乏临床益处导致其停止使用.
- 托塞特拉皮布在治疗混合性脂质不良症和动脉样硬化方面没有显示出临床效用.
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