Effects of intense low-density lipoprotein cholesterol reduction in patients with stroke or transient ischemic attack - The stroke prevention by aggressive reduction in cholesterol levels (SPARCL) trial
Effects of intense low-density lipoprotein cholesterol reduction in patients with stroke or transient ischemic attack - The stroke prevention by aggressive reduction in cholesterol levels (SPARCL) trial
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DOI：
10.1161/strokeaha.107.493106
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发表时间：
2007-12-01
期刊：
影响因子：
8.3
通讯作者：
Welch, K. Michael A.
中科院分区：
文献类型：
--
作者：
Amarenco, Pierre;Goldstein, Larry B.;Welch, K. Michael A.
背景和目的--对安慰剂对照的通过积极降低胆固醇水平预防中风(SPARCL)试验的数据进行意向治疗分析发现，在最近中风或短暂性脑缺血发作的患者中，每天80毫克阿托伐他汀可降低中风和主要冠状动脉事件的风险。尽管在试验过程中随机治疗的依从性只有78%的净差异，但这一益处仍然存在。在这项探索性分析中，我们的目的是评估在基线的基础上实现低密度脂蛋白胆固醇(LDL-C)降低50%的益处和风险。方法--这项特殊分析基于4731名SPARCL患者(平均每名患者11.6次测量)在平均4.9年的随访期间进行的55 045次低密度脂蛋白胆固醇(LDL-C)测量。结果：与低密度脂蛋白胆固醇无变化或升高相比，随时间变化的低密度脂蛋白胆固醇变化分析显示，低密度脂蛋白胆固醇与基线无变化或升高的情况相比，患者的低密度脂蛋白胆固醇水平降低了32.7%。低密度脂蛋白胆固醇降低50%，卒中风险降低31%(危险比，0.69，95%CI，0.55~0.87，P=0.0016)，缺血性卒中降低33%(P=0.0018)，出血性卒中无统计学意义增加(P=0.8864)，主要冠状动脉事件减少37%(P=0.0323)。肌痛或横纹肌溶解的发生率没有增加。在低密度脂蛋白胆固醇降低50%的组中，持续的肝酶升高更为常见。结论：与低密度脂蛋白无变化或升高相比，低密度脂蛋白降低50%与中风和主要冠状动脉事件的风险降低更大，而脑出血没有增加。
Background and Purpose - The intention-to-treat analysis of data from the placebo-controlled Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial found 80 mg atorvastatin per day reduced the risk of stroke and major coronary events in patients with recent stroke or transient ischemic attack. This benefit was present despite only a 78% net difference in adherence to randomized treatment over the course of the trial. In this exploratory analysis, our aim was to evaluate the benefit and risks associated with achieving a >= 50% low-density lipoprotein cholesterol (LDL-C) reduction from baseline.Methods - This post hoc analysis was based on 55 045 LDL-C measurements among the 4731 patients enrolled in SPARCL (average, 11.6 measurements per patient) during a mean follow-up of 4.9 years. At each postrandomization LDL-C assessment, percent change in LDL-C from baseline for each patient was classified as no change or increase from baseline (32.7% of measurements), < 50% LDL-C reduction (39.4%), or >= 50% reduction (27.9%).Results - Compared with no change or an increase in LDL-C, analysis of time-varying LDL-C change showed that patients with < 50% LDL-C reduction had a 31% reduction in stroke risk (hazard ratio, 0.69, 95% CI, 0.55 to 0.87, P=0.0016), a 33% reduction in ischemic stroke (P=0.0018), no statistically significant increase in hemorrhagic stroke (P=0.8864), and a 37% reduction in major coronary events (P=0.0323). There was no increase in the incidence of myalgia or rhabdomyolysis. Persistent liver enzyme elevations were more frequent in the group with < 50% LDL-C reduction.Conclusions - As compared with having no change or an increase in LDL-C, achieving a >= 50% lowering was associated with a greater reduction in the risk of stroke and major coronary events with no increase in brain hemorrhages.