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Original Article
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Volume 355:549-559 August 10, 2006 Number 6
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High-Dose Atorvastatin after Stroke or Transient Ischemic Attack
The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators

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 by Kent, D. M.
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ABSTRACT

Background Statins reduce the incidence of strokes among patients at increased risk for cardiovascular disease; whether they reduce the risk of stroke after a recent stroke or transient ischemic attack (TIA) remains to be established.

Methods We randomly assigned 4731 patients who had had a stroke or TIA within one to six months before study entry, had low-density lipoprotein (LDL) cholesterol levels of 100 to 190 mg per deciliter (2.6 to 4.9 mmol per liter), and had no known coronary heart disease to double-blind treatment with 80 mg of atorvastatin per day or placebo. The primary end point was a first nonfatal or fatal stroke.

Results The mean LDL cholesterol level during the trial was 73 mg per deciliter (1.9 mmol per liter) among patients receiving atorvastatin and 129 mg per deciliter (3.3 mmol per liter) among patients receiving placebo. During a median follow-up of 4.9 years, 265 patients (11.2 percent) receiving atorvastatin and 311 patients (13.1 percent) receiving placebo had a fatal or nonfatal 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 group had 218 ischemic strokes and 55 hemorrhagic strokes, whereas the placebo group had 274 ischemic strokes and 33 hemorrhagic strokes. The five-year absolute reduction in the risk of major cardiovascular events was 3.5 percent (hazard ratio, 0.80; 95 percent confidence interval, 0.69 to 0.92; P=0.002). The overall mortality rate was similar, with 216 deaths in the atorvastatin group and 211 deaths in the placebo group (P=0.98), as were the rates of serious adverse events. Elevated liver enzyme values were more common in patients taking atorvastatin.

Conclusions In patients with recent stroke or TIA and without known coronary heart disease, 80 mg of atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events, despite a small increase in the incidence of hemorrhagic stroke. (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.

Full Text of this Article


Related Letters:

Statin Therapy after Stroke or Transient Ischemic Attack
Cohen J. S., East J. E., Elkind M. S.V., Khan N. A., Mascitelli L., Pezzetta F., Welch K.M.A., the SPARCL Investigators , Kent D.
Extract | Full Text | PDF  
N Engl J Med 2006; 355:2368-2371, Nov 30, 2006. Correspondence

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