普伐他汀对颈动脉内膜中层复合体厚度的长期影响：J-STARS回声研究（日本他汀类药物治疗复发性卒中研究）
Long-Term Effect of Pravastatin on Carotid Intima-Media Complex Thickness: The J-STARS Echo Study (Japan Statin Treatment Against Recurrent Stroke).
作者信息
Koga Masatoshi, Toyoda Kazunori, Minematsu Kazuo, Yasaka Masahiro, Nagai Yoji, Aoki Shiro, Nezu Tomohisa, Hosomi Naohisa, Kagimura Tatsuo, Origasa Hideki, Kamiyama Kenji, Suzuki Rieko, Ohtsuki Toshiho, Maruyama Hirofumi, Kitagawa Kazuo, Uchiyama Shinichiro, Matsumoto Masayasu
机构信息
From the Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan (M.K., K.T., K.M., R.S.); Department of Cerebrovascular Medicine and Neurology, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan (M.Y.); Clinical & Translational Research Center, Kobe University Hospital, Japan (Y.N.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences, Japan (S.A., T.N., N.H., T.O., H.M., M.M.); Foundation for Biomedical Research and Innovation, Translational Research Informatics Center, Kobe, Japan (T.K.); Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences, Japan (H.O.); Department of Neurosurgery and Stroke Center, Nakamura Memorial Hospital, Sapporo, Japan (K.K.); Stroke Center, Kinki University, Osakasayama, Japan (T.O.); Department of Neurology, Tokyo Women's Medical University, Japan (K.K.); International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan (S.U.); and Japan Community Healthcare Organization Hoshigaoka Medical Center, Hirakata (M.M.).
出版信息
Stroke. 2018 Jan;49(1):107-113. doi: 10.1161/STROKEAHA.117.018387. Epub 2017 Nov 30.
BACKGROUND AND PURPOSE
The effect of statins on progression of carotid intima-media complex thickness (IMT) has been shown exclusively in nonstroke Western patients. This study aimed to determine the effect of low-dose pravastatin on carotid IMT in Japanese patients with noncardioembolic ischemic stroke.
METHODS
This is a substudy of the J-STARS trial (Japan Statin Treatment Against Recurrent Stroke), a multicenter, randomized, open-label, parallel-group trial to examine whether pravastatin reduces stroke recurrence. Patients were randomized to receive pravastatin (10 mg daily, usual dose in Japan; pravastatin group) or not to receive any statins (control group). The primary outcome was IMT change of the common carotid artery for a 5-year observation period. IMT change was compared using mixed-effects models for repeated measures.
RESULTS
Of 864 patients registered in this substudy, 71 without baseline ultrasonography were excluded, and 388 were randomly assigned to the pravastatin group and 405 to the control group. Baseline characteristics were not significantly different, except National Institutes of Health Stroke Scale scores (median, 0 [interquartile range, 0-2] versus 1 [interquartile range, 0-2]; =0.019) between the 2 groups. Baseline IMT (mean±SD) was 0.887±0.155 mm in the pravastatin group and 0.887±0.152 mm in the control group (=0.99). The annual change in the IMT at 5-year visit was significantly reduced in the pravastatin group as compared with that in the control group (0.021±0.116 versus 0.040±0.118 mm; =0.010).
CONCLUSIONS
The usual Japanese dose of pravastatin significantly reduced the progression of carotid IMT at 5 years in patients with noncardioembolic stroke.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00361530.
背景与目的
他汀类药物对颈动脉内膜中层复合体厚度（IMT）进展的影响仅在非卒中的西方患者中得到证实。本研究旨在确定低剂量普伐他汀对日本非心源性缺血性卒中患者颈动脉IMT的影响。
方法
这是J-STARS试验（日本他汀类药物预防卒中复发试验）的一项子研究，该试验是一项多中心、随机、开放标签、平行组试验，旨在研究普伐他汀是否能降低卒中复发率。患者被随机分为接受普伐他汀（每日10 mg，日本常用剂量；普伐他汀组）或不接受任何他汀类药物（对照组）。主要结局是5年观察期内颈总动脉IMT的变化。使用重复测量的混合效应模型比较IMT变化。
结果
在该子研究登记的864例患者中，71例无基线超声检查结果被排除，388例被随机分配至普伐他汀组，405例被分配至对照组。除两组间美国国立卫生研究院卒中量表评分（中位数，0[四分位间距，0 - 2]对1[四分位间距，0 - 2]；P = 0.019）外，基线特征无显著差异。普伐他汀组基线IMT（均值±标准差）为0.887±0.155 mm，对照组为0.887±0.152 mm（P = 0.99）。与对照组相比，普伐他汀组在5年随访时IMT的年变化显著降低（0.021±0.116对0.040±0.118 mm；P = 0.010）。
结论
日本常用剂量的普伐他汀可显著降低非心源性卒中患者5年时颈动脉IMT的进展。
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