相关实验视频
利莫纳班特用于预防心血管事件 (CRESCENDO):一个随机,多中心,安慰剂对照试验
Eric J Topol1, Marie-Germaine Bousser, Keith A A Fox
1Scripps Translational Science Institute, La Jolla, CA 92037, USA. etopol@scripps.edu
Lancet (London, England)
|August 17, 2010
概括
作为一种大麻素受体阻断剂的里莫纳班,并没有改善风险患者的无重大血管事件生存率. 由于不可接受的神经精神病学副作用,包括自杀的担忧,试验被提前停止.
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.
- 代谢障碍 代谢障碍 代谢障碍
背景情况:
- 内分泌大麻素受体阻断在减少肥胖和改善代谢参数方面显示出有前途.
- 以前的研究表明,对甘油三,高密度胆固醇和禁食血糖有潜在的益处.
- 这项研究旨在评估里莫纳班特对无重大血管事件生存率的影响.
研究的目的:
- 评估里莫纳班特在改善无重大血管事件生存率方面的疗效.
- 为了确定里莫纳班特是否减少高风险患者的心血管死亡,心肌梗塞或中风.
- 调查里莫纳班特关于心血管和精神疾病不良事件的安全概况.
主要方法:
- 这是一项双盲,安慰剂对照试验,涉及42个国家的974家医院的18695名患者.
- 患者被随机分配,接受里莫纳班特20毫克或与之匹配的安慰剂.
- 主要终点是心血管死亡,心肌梗塞或中风的复合,并进行治疗意图分析.
主要成果:
- 该试验因监管机构对里莫纳班特组自杀的担忧而提前中止.
- 在里莫纳班特和安慰剂组 (3.9%与4.0%) 的初级终点中没有发现显著差异.
- 与安慰剂相比,里莫纳班特显著增加了胃肠道,神经精神和严重的精神病副作用,包括里莫纳班特组中的四起自杀事件.
结论:
- 该试验突出了药物开发的关键教训,特别是关于神经精神病学安全性的教训.
- 利莫纳班特用于减肥,并对心血管结果进行了测试,表现出不可接受的严重神经精神疾病影响.
- 监管机构导致药物和临床试验的突然终止.
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