Callahan Alfred, Amarenco Pierre, Goldstein Larry B, Sillesen Henrik, Messig Mike, Samsa Gregory P, Altafullah Irfan, Ledbetter Lucy Y, MacLeod Mary J, Scott Russell, Hennerici Michael, Zivin Justin A, Welch K Michael A
Vanderbilt University, Nashville, TN, USA.
Arch Neurol. 2011 Oct;68(10):1245-51. doi: 10.1001/archneurol.2011.146. Epub 2011 Jun 13.
To perform a secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial, which tested the effect of treatment with atorvastatin in reducing stroke in subjects with a recent stroke or transient ischemic attack, to explore the effects of treatment in subjects with type 2 diabetes mellitus or metabolic syndrome (MetS).
The 4731 subjects enrolled in the SPARCL trial were classified as having type 2 diabetes mellitus at enrollment (n = 794), MetS retrospectively (n = 642), or neither diabetes nor MetS (n = 3295, the reference group) based on data collected at baseline. Cox regression models were used to determine whether the effect of treatment on the primary end point (combined risk of nonfatal and fatal stroke) and secondary end points (major coronary events, major cardiovascular events, any coronary heart disease event, and any revascularization procedure) varied based on the presence of type 2 diabetes mellitus or MetS.
Subjects with type 2 diabetes mellitus had increased risks of stroke (hazard ratio [HR] = 1.62; 95% confidence interval [CI], 1.33-1.98; P < .001), major cardiovascular events (HR = 1.66; 95% CI, 1.39-1.97; P < .001), and revascularization procedures (HR = 2.39; 95% CI, 1.78-3.19; P < .001) compared with the reference group. Subjects with MetS were not at increased risk for stroke (P = .78) or major cardiovascular events (P = .38) but more frequently had revascularization procedures (HR = 1.78; 95% CI, 1.26-2.5; P = .001). There were no treatment × subgroup interactions for the SPARCL primary end point (P = .47).
The SPARCL subjects with type 2 diabetes were at higher risk for recurrent stroke and cardiovascular events. This exploratory analysis found no difference in the effect of statin treatment in reducing these events in subjects with or without type 2 diabetes or MetS. Trial Registration clinicaltrials.gov Identifier: NCT00147602.
对强化降脂预防卒中（SPARCL）试验进行二次分析，该试验检测了阿托伐他汀治疗对近期发生卒中或短暂性脑缺血发作的受试者降低卒中风险的效果，以探讨治疗对2型糖尿病或代谢综合征（MetS）受试者的影响。
根据基线收集的数据，将SPARCL试验纳入的4731名受试者在入组时分为患有2型糖尿病（n = 794）、回顾性诊断为MetS（n = 642）或既无糖尿病也无MetS（n = 3295，参照组）。采用Cox回归模型确定治疗对主要终点（非致死性和致死性卒中的联合风险）和次要终点（主要冠状动脉事件、主要心血管事件、任何冠心病事件和任何血运重建术）的影响是否因2型糖尿病或MetS的存在而有所不同。
与参照组相比，2型糖尿病受试者发生卒中（风险比[HR]=1.62；95%置信区间[CI]，1.33 - 1.98；P<.001）、主要心血管事件（HR = 1.66；95%CI，1.39 - 1.97；P<.001）和血运重建术（HR = 2.39；95%CI，1.78 - 3.19；P<.001）的风险增加。MetS受试者发生卒中和主要心血管事件的风险未增加（P = 0.78和P = 0.38），但更频繁地接受血运重建术（HR = 1.78；95%CI，1.26 - 2.5；P = 0.001）。SPARCL主要终点无治疗×亚组交互作用（P = 0.47）。
SPARCL试验中患有2型糖尿病的受试者复发性卒中和心血管事件风险更高。这项探索性分析发现，他汀类药物治疗对有或无2型糖尿病或MetS的受试者降低这些事件的效果无差异。试验注册 clinicaltrials.gov标识符：NCT00147602。
