Naohisa Hosomi1, Yoji Nagai2, Kazuo Kitagawa3, Yoko Nakagawa4, Shiro Aoki1, Tomohisa Nezu1, Tatsuo Kagimura4, Hirofumi Maruyama1, Hideki Origasa5, Kazuo Minematsu6, Shinichiro Uchiyama7, Masayasu Matsumoto1,8. 1. Department of Clinical Neuroscience and Therapeutics, Hiroshima University Graduate School of Biomedical and Health Sciences. 2. Center for Clinical Research, Kobe University Hospital. 3. Department of Neurology, Tokyo Women's Medical University School of Medicine. 4. Division of Medical Statistics, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation. 5. Division of Biostatistics and Clinical Epidemiology, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences. 6. National Cerebral and Cardiovascular Center. 7. International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center. 8. Hoshigaoka Medical Center, Japan Community Healthcare Organization (JCHO).
Abstract
AIMS: The J-STARS study examined whether pravastatin (10 mg/day) reduces recurrence of stroke in non-cardioembolic ischemic stroke patients who were enrolled within 1 month to 3 years after initial stroke events (ClinicalTrials.gov, NCT00221104). The main results showed that the frequency of atherothrombotic stroke was low in pravastatin-treated patients, although no effect of pravastatin was found for the other stroke subtypes. We evaluated differences of early (within 6 months) or late (after 6 months) pravastatin treatment benefits on the incidence of stroke or transient ischemic attack (TIA), as well as atherothrombotic stroke and the other subtypes. METHODS: Subjects in the J-STARS study were classified into two cohorts, depending on whether they enrolled early (1 to 6 months) or late (6 months to 3 years) following initial stroke events. RESULTS: A total of 1578 patients (491 female, 66.2±8.5 years) were randomly assigned to either the pravastatingroup (n=793; n=426in the early cohort, n=367 in the late cohort) or the control group (n=785; n=417in the early cohort, n=368 in the late cohort). During the follow-up of 4.9± 1.4 years, the rate of atherothrombotic stroke was lower in the pravastatin group compared to controls in the early cohort (0.24 vs. 0.88%/year, p=0.01) but not in the late cohort (0.17 vs. 0.39%/year, p=0.29). However, this difference of pravastatin effect on atherothrombotic stroke was not significantly interacted by the early or late cohort (p=0.59). The incidence rates of other stroke subtype were not different in between pravastatin and control groups despite the timing of entry. CONCLUSIONS:Pravastatin is likely to reduce atherothrombotic stroke in patients enrolled within 6 months after stroke onset. However, the clinical efficacy for prevention of recurrent stroke was not conclusive with earlier statin treatment.
RCT Entities:
AIMS: The J-STARS study examined whether pravastatin (10 mg/day) reduces recurrence of stroke in non-cardioembolic ischemic strokepatients who were enrolled within 1 month to 3 years after initial stroke events (ClinicalTrials.gov, NCT00221104). The main results showed that the frequency of atherothrombotic stroke was low in pravastatin-treated patients, although no effect of pravastatin was found for the other stroke subtypes. We evaluated differences of early (within 6 months) or late (after 6 months) pravastatin treatment benefits on the incidence of stroke or transient ischemic attack (TIA), as well as atherothrombotic stroke and the other subtypes. METHODS: Subjects in the J-STARS study were classified into two cohorts, depending on whether they enrolled early (1 to 6 months) or late (6 months to 3 years) following initial stroke events. RESULTS: A total of 1578 patients (491 female, 66.2±8.5 years) were randomly assigned to either the pravastatin group (n=793; n=426 in the early cohort, n=367 in the late cohort) or the control group (n=785; n=417 in the early cohort, n=368 in the late cohort). During the follow-up of 4.9± 1.4 years, the rate of atherothrombotic stroke was lower in the pravastatin group compared to controls in the early cohort (0.24 vs. 0.88%/year, p=0.01) but not in the late cohort (0.17 vs. 0.39%/year, p=0.29). However, this difference of pravastatin effect on atherothrombotic stroke was not significantly interacted by the early or late cohort (p=0.59). The incidence rates of other stroke subtype were not different in between pravastatin and control groups despite the timing of entry. CONCLUSIONS:Pravastatin is likely to reduce atherothrombotic stroke in patients enrolled within 6 months after stroke onset. However, the clinical efficacy for prevention of recurrent stroke was not conclusive with earlier statin treatment.
Authors: Pierre Amarenco; Julien Bogousslavsky; Alfred Callahan; Larry B Goldstein; Michael Hennerici; Amy E Rudolph; Henrik Sillesen; Lisa Simunovic; Michael Szarek; K M A Welch; Justin A Zivin Journal: N Engl J Med Date: 2006-08-10 Impact factor: 91.245