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预防卒中复发的理想低密度脂蛋白胆固醇水平:J-STARS 研究(日本他汀类药物治疗复发性卒中)的事后分析。

Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke).

机构信息

From the Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Japan (N.H., S.A., T.N., H.M., M.M.); Department of Neurology, Tokyo Women's Medical University School of Medicine, Japan (K.K.); Center for Clinical Research, Kobe University Hospital, Japan (Y. Nagai); Division of Medical Statistics, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan (Y. Nakagawa, T.K.); Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Japan (H.O.); National Cerebral and Cardiovascular Center, Suita, Japan (K.M.); International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan (S.U.); and Hoshigaoka Medical Center, Japan Community Healthcare Organization, Hirakata, Japan (M.M.).

出版信息

Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.

Abstract

BACKGROUND AND PURPOSE

To define desirable target low-density lipoprotein (LDL) cholesterol levels for the prevention of stroke recurrence, a post hoc analysis was performed in the J-STARS study (Japan Statin Treatment Against Recurrent Stroke).

METHODS

Subjects (n=1578) were divided into groups based on mean value of postrandomized LDL cholesterol levels until the last observation in 20 mg/dL increments. Adjusted hazard ratios (HRs) and 95% confidence intervals were analyzed for each group, with adjustments for baseline LDL cholesterol, baseline body mass index, hypertension, diabetes mellitus, and statin usage.

RESULTS

The postrandomized LDL cholesterol level until the last observation were 104.1±19.3 mg/dL in the pravastatin group and 126.1±20.6 mg/dL in the control group. The adjusted HRs for stroke and transient ischemic attack and all vascular events decreased in the postrandomized LDL cholesterol level of 80 to 100 mg/dL (=0.23 and 0.25 for the trend, respectively). The adjusted HR for atherothrombotic infarction significantly reduced with the usage of statin after adjusting baseline LDL cholesterol levels (HR, 0.39; 95% confidence intervals, 0.19-0.83). The adjusted HR for atherothrombotic infarction and intracranial hemorrhage were similar among the postrandomized LDL-cholesterol-level subgroups (=0.50 and 0.37 for the trend, respectively). The adjusted HR for lacunar infarction decreased in the postrandomized LDL cholesterol level of 100 to 120 mg/dL (HR, 0.45; 95% confidence intervals, 0.20-0.99; =0.41 for the trend).

CONCLUSIONS

The composite risk of stroke and transient ischemic attack reduced in the postrandomized LDL cholesterol level of 80 to 100 mg/dL after adjusting for statin usage.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00221104.

摘要

背景与目的

为了明确预防中风复发时理想的目标低密度脂蛋白胆固醇(LDL-C)水平,我们对 J-STARS 研究(日本他汀类药物治疗复发性中风研究)进行了事后分析。

方法

根据随机分组后 LDL-C 水平的平均值,将受试者(n=1578)分为每组 20mg/dL 的亚组。使用调整后的风险比(HR)和 95%置信区间对每个亚组进行分析,调整了基线 LDL-C、基线体重指数、高血压、糖尿病和他汀类药物的使用。

结果

在普伐他汀组和对照组中,最后一次观察时的随机 LDL-C 水平分别为 104.1±19.3mg/dL 和 126.1±20.6mg/dL。在 80 至 100mg/dL 的随机 LDL-C 水平下,中风和短暂性脑缺血发作及所有血管事件的调整后 HR 呈下降趋势(趋势的 HR 分别为 0.23 和 0.25)。在调整了基线 LDL-C 水平后,他汀类药物的使用使动脉粥样硬化血栓形成性梗死的调整后 HR 显著降低(HR,0.39;95%置信区间,0.19-0.83)。在随机 LDL-C 水平亚组中,动脉粥样硬化血栓形成性梗死和颅内出血的调整后 HR 相似(趋势的 HR 分别为 0.50 和 0.37)。在随机 LDL-C 水平为 100 至 120mg/dL 时,腔隙性梗死的调整后 HR 下降(HR,0.45;95%置信区间,0.20-0.99;趋势的 HR 为 0.41)。

结论

在调整了他汀类药物的使用后,在随机 LDL-C 水平为 80 至 100mg/dL 时,中风和短暂性脑缺血发作的复合风险降低。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00221104。

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