符合进一步心血管结局研究用前蛋白转化酶枯草溶菌素 9 抑制剂在高危人群中（FOURIER）试验纳入标准的非裔美国人和白人的特征和心血管疾病事件发生率。
Characteristics and Cardiovascular Disease Event Rates among African Americans and Whites Who Meet the Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) Trial Inclusion Criteria.
机构信息
Department of Epidemiology, University of Alabama at Birmingham, 1720 2nd Ave. South, RPHB 527C, Birmingham, AL, 35294-0013, USA.
Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.
出版信息
Cardiovasc Drugs Ther. 2019 Apr;33(2):189-199. doi: 10.1007/s10557-019-06864-2.
PURPOSE
Determine the risk for cardiovascular disease (CVD) events among adults with clinically evident CVD who meet the inclusion criteria for the FOURIER clinical trial on PCSK9 inhibition in a real-world database.
METHODS
We analyzed data from 2072 African American and 2972 white REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants 45-85 years of age with clinically evident CVD. Study participants meeting the FOURIER inclusion criteria (one major or two minor cardiovascular risk factors, fasting LDL cholesterol ≥ 70 mg/dL or non-HDL cholesterol ≥ 100 mg/dL, triglycerides ≤ 400 mg/dL, and taking statin) were followed for CVD events (myocardial infarction, stroke, coronary revascularization, and CVD death) from baseline in 2003-2007 through 2014.
RESULTS
Overall, 771 (37.2%) African Americans and 1200 (40.4%) whites met the FOURIER inclusion criteria. The CVD event rate per 1000 person years was 60.6 (95% CI 53.6-67.6) among African Americans and 63.5 (95% CI 57.7-69.3) among whites. The risk for CVD events among adults meeting the FOURIER inclusion criteria was higher for those with a history of multiple cardiovascular events (hazard ratios among African Americans and whites 1.34 [95% CI 1.05-1.71] and 1.34 [1.10-1.63], respectively), a prior coronary revascularization (1.44 [1.13-1.84] and 1.23 [1.00-1.52], respectively), diabetes (1.38 [1.08-1.76] and 1.41 [1.15-1.72], respectively), reduced glomerular filtration rate (1.63 [1.26-2.11] and 1.29 [1.03-1.62], respectively), and albuminuria (1.77 [1.37-2.27] and 1.33 [1.07-1.65], respectively).
CONCLUSIONS
The CVD event rate is high among African Americans and whites meeting the FOURIER inclusion criteria. Characteristics associated with a higher CVD risk may inform the decision to initiate PCSK9 inhibition.
目的
在一个真实世界的数据库中，确定符合 FOURIER 临床试验 PCSK9 抑制条件的有临床明显心血管疾病（CVD）的成年人发生心血管疾病（CVD）事件的风险。
方法
我们分析了 2072 名年龄在 45-85 岁之间的非洲裔美国人和 2972 名白种人 REasons for Geographic And Racial Differences in Stroke（REGARDS）研究参与者的数据，这些参与者有临床明显的 CVD。研究参与者符合 FOURIER 纳入标准（一个主要或两个次要心血管危险因素，空腹 LDL 胆固醇≥70mg/dL 或非高密度脂蛋白胆固醇≥100mg/dL，甘油三酯≤400mg/dL，且服用他汀类药物），从 2003-2007 年的基线开始，随访 CVD 事件（心肌梗死、中风、冠状动脉血运重建和 CVD 死亡）至 2014 年。
结果
总体而言，771 名（37.2%）非洲裔美国人和 1200 名（40.4%）白人符合 FOURIER 纳入标准。非洲裔美国人的 CVD 事件发生率为每 1000 人年 60.6（95%可信区间 53.6-67.6），白种人发生率为 63.5（95%可信区间 57.7-69.3）。在符合 FOURIER 纳入标准的成年人中，有多次心血管事件史（非洲裔美国人和白种人的风险比分别为 1.34 [95%可信区间 1.05-1.71]和 1.34 [1.10-1.63]）、既往冠状动脉血运重建（1.44 [1.13-1.84]和 1.23 [1.00-1.52]）、糖尿病（1.38 [1.08-1.76]和 1.41 [1.15-1.72]）、肾小球滤过率降低（1.63 [1.26-2.11]和 1.29 [1.03-1.62]）和白蛋白尿（1.77 [1.37-2.27]和 1.33 [1.07-1.65]）的成年人发生 CVD 事件的风险更高。
结论
符合 FOURIER 纳入标准的非洲裔美国人和白种人 CVD 事件发生率较高。与更高 CVD 风险相关的特征可能有助于决定是否开始使用 PCSK9 抑制剂。
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