Effect and Safety of Rosuvastatin in Acute Ischemic Stroke.
Effect and Safety of Rosuvastatin in Acute Ischemic Stroke.
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DOI：
10.5853/jos.2015.01578
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发表时间：
2016-01
影响因子：
8.2
通讯作者：
EUREKA Investigators
中科院分区：
文献类型：
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作者：
Heo JH;Song D;Nam HS;Kim EY;Kim YD;Lee KY;Lee KJ;Yoo J;Kim YN;Lee BC;Yoon BW;Kim JS;EUREKA Investigators
他汀类药物对急性卒中的益处仍不确定。他汀类药物可通过多效性作用预防中风急性期的复发。然而，他汀类药物可能会增加脑出血的风险。我们观察了瑞舒伐他汀对急性卒中患者的疗效和安全性。这项随机、双盲、多中心试验比较了在症状出现后48小时内接受弥散加权成像(DWI)的他汀类单纯中风患者中瑞舒伐他汀20毫克和安慰剂的疗效。主要结果是在5天或14天的弥散加权成像上出现新的缺血灶。由于登记缓慢，这项试验在316名患者随机后提前停止。在289名至少有一次随访的患者中，磁共振弥散加权成像显示新的缺血性病变的频率在两组间没有差异(瑞舒伐他汀：27/137，19.7%与安慰剂：36/152，23.6%)(相对危险度0.83，95%可信区间0.53-1.30)。第5天的脑梗塞体积增长(对数转换体积变化，瑞舒伐他汀：0.2±1.0mm3与安慰剂组：0.3±1.3mm3；P=0.784)也没有差别。然而，梯度回波磁共振成像显示，瑞舒伐他汀组出血性脑梗塞或脑实质/蛛网膜下腔出血的发生率(6/137，4.4%)低于安慰剂组(22/152，14.5%，P=0.007)。在服用至少一剂研究药物的314名患者中，瑞舒伐他汀组中风的进展或临床复发的发生率较低(1/155，0.6%vs.7/159，4.4%，P=0.067)。不良事件在不同组之间没有差异。瑞舒伐他汀在减少急性卒中复发方面的疗效尚不确定。然而，他汀类药物的使用是安全的，并减少了出血性转化。
The benefit of statins in acute stroke remains uncertain. Statins may prevent stroke recurrence during the acute stage of stroke via pleiotropic effects. However, statins may increase the risk of intracerebral hemorrhage. We investigated the effect and safety of rosuvastatin in acute stroke patients. This randomized, double-blind, multi-center trial compared rosuvastatin 20 mg and placebo in statin-naïve stroke patients who underwent diffusion-weighted imaging (DWI) within 48 hours after symptom onset. The primary outcome was occurrence of new ischemic lesions on DWI at 5 or 14 days. This trial was stopped early after randomization of 316 patients due to slow enrollment. Among 289 patients with at least one follow-up imaging, the frequency of new ischemic lesions on DWI was not different between groups (rosuvastatin: 27/137, 19.7% vs. placebo: 36/152, 23.6%) (relative risk 0.83, 95% confidence interval 0.53–1.30). Infarct volume growth at 5 days (log-transformed volume change, rosuvastatin: 0.2±1.0 mm3 vs. placebo: 0.3±1.3 mm3; P=0.784) was not different, either. However, hemorrhagic infarction or parenchymal/subarachnoid hemorrhage on gradient-recalled echo magnetic resonance imaging occurred less frequently in the rosuvastatin group (6/137, 4.4%) than the placebo group (22/152, 14.5%, P=0.007). Among 314 patients with at least one dose of study medication, progression or clinical recurrence of stroke tended to occur less frequently in the rosuvastatin group (1/155, 0.6% vs. 7/159, 4.4%, P=0.067). Adverse events did not differ between groups. The efficacy of rosuvastatin in reducing recurrence in acute stroke was inconclusive. However, statin use was safe and reduced hemorrhagic transformation.