Rosuvastatin for primary prevention in older persons with elevated C-reactive protein and low to average low-density lipoprotein cholesterol levels: exploratory analysis of a randomized trial.

Rosuvastatin for primary prevention in older persons with elevated C-reactive protein and low to average low-density lipoprotein cholesterol levels: exploratory analysis of a randomized trial.
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DOI:
10.7326/0003-4819-152-8-201004200-00005
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发表时间:
2010-04-20
影响因子:
39.2
通讯作者:
Ridker PM
Ridker PM
中科院分区:
医学1区
文献类型:
--
作者:
Glynn RJ;Koenig W;Nordestgaard BG;Shepherd J;Ridker PM

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关于他汀类药物用于老年人一级预防的随机数据有限,与胆固醇升高相关的心血管疾病的相对危险性随着年龄的增长而减弱。评估瑞舒伐他汀在70岁或以上患者中的疗效和安全性。JUPITER试验的次要分析,一项随机、双盲、安慰剂对照试验。26个国家的1315家研究中心在JUPITER中对受试者进行了随机化。在17802名随机参与者中,低密度脂蛋白胆固醇(LDL)水平低于130 mg/dL,高敏C反应蛋白水平为2.0 mg/L或更高,并且没有心血管疾病,5695名年龄在70岁或以上。受试者以1:1的比例随机分配接受每日20 mg瑞舒伐他汀或安慰剂。主要终点是首次心血管事件(心肌梗死、卒中、动脉血运重建、因不稳定型心绞痛住院或心血管原因死亡)的发生。32%的70岁或以上的试验参与者累积了393个确认的主要终点的49%(N=194)。瑞舒伐他汀组和安慰剂组在该年龄组的主要终点发生率分别为1.22和1.99/100人-年(风险比0.61; [95%CI,0.46 - 0.82]; P<0.001)。该年龄组的相应全因死亡率分别为1.63和2.04(风险比0.80; [95%CI,0.62 - 1.04]; P=0.090)。虽然按年龄的治疗效应无显著异质性,但与瑞舒伐他汀相关的事件发生率的绝对降低在老年个体中更大。瑞舒伐他汀组与安慰剂组老年人中任何严重不良事件的相对发生率为1.05(95% CI:0.93-1.17)。应在总体试验结果的背景下查看该探索性分析的效应估计值(在试验完成后选择年龄临界点)。在无高脂血症但高敏C反应蛋白升高的明显健康老年人中,瑞舒伐他汀可降低主要心血管事件的发生率。阿斯利康
There are limited randomized data on statins for primary prevention in older people, and the relative hazard of cardiovascular disease associated with elevated cholesterol weakens with advancing age. To assess the efficacy and safety of rosuvastatin in individuals 70 years of age or older. Secondary analysis of the JUPITER trial, a randomized, double-blind, placebo-controlled trial. 1315 sites in 26 countries randomized subjects in JUPITER. Among the 17802 randomized participants with low-density lipoprotein cholesterol (LDL) levels of less than 130 mg/dL and high-sensitivity C-reactive protein levels of 2.0 mg/L or higher, and without cardiovascular disease, 5695 were 70 years of age or older. Participants were randomly assigned in a 1:1 ratio to receive 20 mg rosuvastatin daily or placebo. The primary end point was the occurrence of a first cardiovascular event (myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes). The 32% of trial participants aged 70 years or older accrued 49% (N=194) of the 393 confirmed primary end points. The rates of the primary end point in this age group were 1.22 and 1.99 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio 0.61; [95% CI, 0.46 to 0.82]; P<0.001). Corresponding rates of all-cause mortality in this age group were 1.63 and 2.04 (hazard ratio 0.80; [95% CI, 0.62 to 1.04]; P=0.090). While there was no significant heterogeneity in treatment effects by age, absolute reductions in event rates associated with rosuvastatin were greater in older individuals. The relative rate of any serious adverse event among older people in the rosuvastatin group versus placebo was 1.05 (95% CI: 0.93–1.17). Effect estimates from this exploratory analysis with age cutpoint chosen after trial completion should be viewed in the context of the overall trial results. In apparently healthy older people without hyperlipidemia but with elevated high-sensitivity C-reactive protein, rosuvastatin reduces the incidence of major cardiovascular events. AstraZeneca
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