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.).
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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]; P=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 (P=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; P=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.