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种族、民族与罗苏伐他汀在一级预防中的疗效:他汀类药物预防心血管疾病的应用论证:一项评价罗苏伐他汀的干预试验(JUPITER 试验)。

Race, ethnicity, and the efficacy of rosuvastatin in primary prevention: the Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial.

机构信息

Division of Cardiovascular Diseases, Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.

出版信息

Am Heart J. 2011 Jul;162(1):106-14.e2. doi: 10.1016/j.ahj.2011.03.032. Epub 2011 Jun 12.

DOI:10.1016/j.ahj.2011.03.032
PMID:21742096
Abstract

OBJECTIVES

The aim of this study was to evaluate the effect of statin treatment in primary prevention of cardiovascular events in different race/ethnic groups.

BACKGROUND

Clinical trial evidence about the efficacy of statins in the primary prevention of cardiovascular events among nonwhites is uncertain.

METHODS

JUPITER trial, a randomized, double-blind, placebo-controlled evaluation of rosuvastatin 20 mg in the primary prevention of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for unstable angina, and cardiovascular death included 12,683 whites and 5,117 nonwhites with low-density lipoprotein levels <130 mg/dL and high-sensitivity C-reactive protein levels ≥2.0 mg/L.

RESULTS

Random allocation to rosuvastatin resulted in a 45% reduction in the primary end point among whites (hazard ratio [HR] 0.55, 95% CI 0.43-0.69) and a 37% reduction among nonwhites (HR 0.63, 95% CI 0.41-0.99). Blacks (HR 0.65, 95% CI 0.35-1.22) and Hispanics (HR 0.58, 95% CI 0.25-1.39) had similar risk reductions. Among nonwhites in the placebo group, the stroke rate exceeded the MI rate (0.44 vs 0.20 per 100 person-years); an opposite pattern was observed among whites (0.31 vs 0.42 per 100 person-years). Nonwhites had higher death rates than whites (2.25 vs 0.93 per 100 person-years); however, all-cause mortality was similar at 20% with rosuvastatin treatment in both participant groups.

CONCLUSIONS

When used in primary prevention among individuals with low-density lipoprotein <130 mg/dL and high-sensitivity C-reactive protein ≥2 mg/L, rosuvastatin significantly reduced first MI, stroke, arterial revascularization, hospitalization for unstable angina, and cardiovascular death among whites and nonwhites.

摘要

目的

本研究旨在评估他汀类药物在不同种族/族裔人群一级预防心血管事件中的作用。

背景

关于非白人人群中他汀类药物在一级预防心血管事件中的疗效的临床试验证据尚不确定。

方法

JUPITER 试验是一项随机、双盲、安慰剂对照的评估瑞舒伐他汀 20mg 在预防心肌梗死(MI)、中风、动脉血运重建、不稳定型心绞痛住院和心血管死亡的主要终点的临床试验,共纳入 12683 名白人患者和 5117 名非白人患者,他们的低密度脂蛋白水平<130mg/dL,高敏 C 反应蛋白水平≥2.0mg/L。

结果

瑞舒伐他汀随机分配导致白人患者主要终点降低 45%(风险比[HR]0.55,95%置信区间[CI]0.43-0.69),非白人患者降低 37%(HR 0.63,95%CI 0.41-0.99)。黑人(HR 0.65,95%CI 0.35-1.22)和西班牙裔(HR 0.58,95%CI 0.25-1.39)的风险降低相似。在安慰剂组的非白人患者中,中风发生率超过 MI 发生率(0.44 比 0.20 每 100 人年);白人患者则相反(0.31 比 0.42 每 100 人年)。非白人的死亡率高于白人(2.25 比 0.93 每 100 人年);然而,在两组患者中,接受瑞舒伐他汀治疗的全因死亡率相似,均为 20%。

结论

在低密度脂蛋白<130mg/dL 和高敏 C 反应蛋白≥2mg/L 的人群中,瑞舒伐他汀在一级预防中显著降低了白人及非白人患者的首次 MI、中风、动脉血运重建、不稳定型心绞痛住院和心血管死亡。

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