Background Statins reduce the incidence of strokes among patientsat increased risk for cardiovascular disease; whether they reducethe risk of stroke after a recent stroke or transient ischemicattack (TIA) remains to be established.
Methods We randomly assigned 4731 patients who had had a strokeor TIA within one to six months before study entry, had low-densitylipoprotein (LDL) cholesterol levels of 100 to 190 mg per deciliter(2.6 to 4.9 mmol per liter), and had no known coronary heartdisease to double-blind treatment with 80 mg of atorvastatinper day or placebo. The primary end point was a first nonfatalor fatal stroke.
Results The mean LDL cholesterol level during the trial was73 mg per deciliter (1.9 mmol per liter) among patients receivingatorvastatin and 129 mg per deciliter (3.3 mmol per liter) amongpatients receiving placebo. During a median follow-up of 4.9years, 265 patients (11.2 percent) receiving atorvastatin and311 patients (13.1 percent) receiving placebo had a fatal ornonfatal stroke (5-year absolute reduction in risk, 2.2 percent;adjusted hazard ratio, 0.84; 95 percent confidence interval,0.71 to 0.99; P=0.03; unadjusted P=0.05). The atorvastatin grouphad 218 ischemic strokes and 55 hemorrhagic strokes, whereasthe placebo group had 274 ischemic strokes and 33 hemorrhagicstrokes. The five-year absolute reduction in the risk of majorcardiovascular events was 3.5 percent (hazard ratio, 0.80; 95percent confidence interval, 0.69 to 0.92; P=0.002). The overallmortality rate was similar, with 216 deaths in the atorvastatingroup and 211 deaths in the placebo group (P=0.98), as werethe rates of serious adverse events. Elevated liver enzyme valueswere more common in patients taking atorvastatin.
Conclusions In patients with recent stroke or TIA and withoutknown coronary heart disease, 80 mg of atorvastatin per dayreduced the overall incidence of strokes and of cardiovascularevents, despite a small increase in the incidence of hemorrhagicstroke. (ClinicalTrials.gov number, NCT00147602
[ClinicalTrials.gov]
.)
Source Information
Pierre Amarenco, M.D. (Denis Diderot University, Paris), Julien Bogousslavsky, M.D. (University of Lausanne, Lausanne, Switzerland), Alfred Callahan, III, M.D. (Neurologic Consultants, Nashville), Larry B. Goldstein, M.D. (Duke University Medical Center, Durham, N.C.), Michael Hennerici, M.D., Ph.D. (Universitat Heidelberg, Mannheim, Germany), Amy E. Rudolph, Ph.D. (Pfizer, New York), Henrik Sillesen, M.D., D.M.Sc. (University of Copenhagen, Copenhagen), Lisa Simunovic, M.S. (Pfizer, New York), Michael Szarek, M.S. (Pfizer, New York), K.M.A. Welch, M.B., Ch.B., (Rosalind Franklin University of Medicine and Science, North Chicago), and Justin A. Zivin, M.D., Ph.D. (University of California, San Diego) assume full responsibility for the overall content and integrity of the article.
Address reprint requests to Dr. Welch at the Rosalind Franklin University of Medicine and Science, 3333 Green Bay Rd., North Chicago, IL 60064, or at michael.welch{at}rosalindfranklin.edu.
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