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无心血管疾病的中危人群的降胆固醇治疗
Cholesterol Lowering in Intermediate-Risk Persons without Cardiovascular Disease


Salim Yusuf ... 心脑血管疾病 • 2016.05.26
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摘要


背景

以前的试验显示,他汀类药降胆固醇治疗可以减少无心血管疾病人群的心血管事件风险。那些试验包含的是血脂或炎症指标升高的人群,且主要包含了白种人。他汀类药物的获益是否可以扩展至中等危险、种族多样化的无心血管疾病人群,目前尚不清楚。

 

方法

在一项源于2×2析因试验的比较中,我们将来自21个国家的12,705例无心血管疾病的中危参与者随机分配至每天接受10 mg瑞舒伐他汀组或安慰剂组。第一复合主要结局为下列事件的复合:心血管因素死亡、非致死性心肌梗死或非致死性卒中;第二联合主要结局另外还包括血运重建、心力衰竭及心搏骤停复苏。中位随访时间为5.6年。

 

结果

瑞舒伐他汀组的总平均低密度脂蛋白胆固醇水平比安慰剂组低26.5%。在瑞舒伐他汀组和安慰剂组,第一复合主要结局的发生例数分别为235例(3.7%)和304例(4.8%)(风险比为0.76,95%可信区间[CI]为0.64~0.91;P=0.002)。第二复合主要结局的情况与第一复合主要结局相似,瑞舒伐他汀组和安慰剂组的发生例数分别为277例(4.4%)和363例(5.7%)(风险比为0.75,95%可信区间为0.64~0.88;P<0.001)。在根据基线心血管风险、血脂水平、C反应蛋白水平、血压和种族/民族定义的亚组分析中,也得到与上述情况一致的结果。在瑞舒伐他汀组,糖尿病和肿瘤的发生率未增加,但白内障手术(瑞舒伐他汀组的3.8%对应安慰剂组的3.1%;P=0.02)和肌肉症状发生率(瑞舒伐他汀组的5.8%对应安慰剂组的4.7%;P=0.005)有所增加。

 

结论

对于中等危险、种族多样化的无心血管疾病人群,每天10 mg剂量的瑞舒伐他汀治疗和安慰剂相比,可以显著降低心血管事件的风险(由加拿大卫生研究院[Canadian Institutes of Health Research]和阿斯利康公司[AstraZeneca]资助;HOPE-3在ClinicalTrials.gov注册号为NCT00468923)。





作者信息

Salim Yusuf, M.B., B.S., D.Phil., Jackie Bosch, Ph.D., Gilles Dagenais, M.D., Jun Zhu, M.D., Denis Xavier, M.D., Lisheng Liu, M.D., Prem Pais, M.D., Patricio López-Jaramillo, M.D., Ph.D., Lawrence A. Leiter, M.D., Antonio Dans, M.D., Alvaro Avezum, M.D., Ph.D., Leopoldo S. Piegas, M.D., Ph.D., Alexander Parkhomenko, M.D., Ph.D., Katalin Keltai, M.D., Ph.D., Matyas Keltai, M.D., Ph.D., Karen Sliwa, M.D., Ph.D., Ron J.G. Peters, M.D., Ph.D., Claes Held, M.D., Ph.D., Irina Chazova, M.D., Ph.D., Khalid Yusoff, M.D., Basil S. Lewis, M.D., Petr Jansky, M.D., Kamlesh Khunti, M.D., Ph.D., William D. Toff, M.D., Christopher M. Reid, Ph.D., John Varigos, B.Sc., Gregorio Sanchez-Vallejo, M.D., Robert McKelvie, M.D., Ph.D., Janice Pogue, Ph.D., *Hyejung Jung, M.Sc., Peggy Gao, M.Sc., Rafael Diaz, M.D., and Eva Lonn, M.D., for the HOPE-3 Investigators†
The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Address reprint requests to Dr. Yusuf at the Population Health Research Institute, 237 Barton St. E., Hamilton, ON L8L 2X2, Canada, or at yusufs@mcmaster.ca. *Deceased. †A complete list of the Heart Outcomes Prevention Evaluation (HOPE)–3 trial investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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