Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.
Foundation for Biomedical Research and Innovation Translational Research Informatics Center, Kobe, Japan.
EBioMedicine. 2015 Aug 6;2(9):1071-8. doi: 10.1016/j.ebiom.2015.08.006. eCollection 2015 Sep.
Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients.
This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints.
Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events.
Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis.
This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.
尽管他汀类药物治疗有益于预防首发卒中，但在亚洲人群中，其对复发性卒中和其亚型的益处仍有待确定，因为亚洲人群的卒中类型与高加索人群不同。本研究旨在探讨小剂量普伐他汀是否可预防缺血性卒中患者的卒中复发。
这是一项多中心、随机、开放标签、盲终点、平行组研究，纳入了经历非心源性缺血性卒中的患者。所有患者在入组时的总胆固醇水平为 4.65 至 6.21mmol/L，且未使用他汀类药物。普伐他汀组患者接受 10mg 普伐他汀/天治疗；对照组患者未接受他汀类药物治疗。主要终点为卒中及短暂性脑缺血发作（TIA）的发生，每种卒中亚型的发生均设为次要终点之一。
虽然目标患者人数为 3000 例，但纳入了 1578 例患者（491 例女性，年龄 66.2 岁），并随机分至普伐他汀组或对照组。在 4.9±1.4 年的随访期间，两组的总卒中及 TIA 发生率相似（2.56%与 2.65%/年），但普伐他汀组的动脉粥样硬化性血栓性脑梗死发生率较低（0.21%与 0.64%/年，p=0.0047，校正后风险比 0.33[95%CI 0.15 至 0.74]）。两组其他卒中亚型的发生率及不良事件的发生无显著组间差异。
尽管小剂量普伐他汀是否可预防亚洲人群的总卒中或 TIA 复发仍有待研究，但本研究提出了一个假设，即普伐他汀可能通过减少大动脉粥样硬化性卒中的发生而发挥作用。
本研究最初由日本厚生劳动省资助。在政府资助结束后，本研究由广岛大学与生物医学研究与创新基金会合作进行。
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