高剂量阿托瓦斯塔丁与通常剂量西姆瓦斯塔丁用于心肌梗塞后的二次预防:IDEAL研究:一种随机对照试验
Terje R Pedersen1, Ole Faergeman, John J P Kastelein
1Centre for Preventive Medicine, Ullevål University Hospital, Oslo, Norway. t.r.pedersen@medisin.uio.no
JAMA
|November 17, 2005
概括
高剂量阿托瓦斯塔丁的强化低密度脂蛋白胆固醇 (LDL-C) 降低并没有显著减少先前心肌梗塞 (MI) 患者的主要冠状动脉事件. 然而,它确实降低了非致命性心脏病发作和其他复合二次终点的风险,而不会增加死亡率.
科学领域:
- 心脏病学 心脏病学
- 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:
- 有证据表明,强化降低低密度脂蛋白胆固醇 (LDL-C) 对稳定的冠状动脉疾病有好处.
- 对于已确定的冠状动脉疾病患者的最佳LDL-C降低值仍在研究中.
研究的目的:
- 为了比较高剂量阿托瓦斯塔丁与常用剂量西姆瓦斯塔丁在减少心血管事件的疗效,在患有心肌梗塞 (MI) 病史的患者.
主要方法:
- IDEAL研究是一项前性,随机化,开放性试验,涉及8888名患有心脏病史的患者.
- 患者接受高剂量阿托瓦斯塔丁 (80毫克/天) 或通常剂量西姆瓦斯塔丁 (20毫克/天),随访时间中位数为4.8年.
主要成果:
- 阿托瓦斯塔丁组的平均LDL-C水平 (81 mg/dL) 与西姆瓦斯塔丁组 (104 mg/dL) 相比较低.
- 在9.3%的阿托瓦斯塔丁患者和10.4%的西姆瓦斯塔丁患者中发生了重大冠状动脉事件 (HR,0.89;P = .07).
- 非致命性MI (6.0%与7.2%相比;P = .02) 和主要心血管事件 (P = .02) 在阿托瓦斯塔丁组显著减少. 没有观察到心血管或全因死亡率的差异.
结论:
- 高剂量阿托瓦斯塔丁的强化降低LDL-C并没有显著减少主要冠状动脉事件,但确实减少了先前心脏病患者的非致命性心脏病发作和其他复合次要终点.
- 这种策略与转氨酶的升高有关,但心血管或全因死亡率或肌肉病变等严重不良事件的增加没有增加.
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