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Odkazy a zdroje - Studie - SPARCL


Stroke Prevention by Aggressive Reduction in Cholesterol Levels

(a) The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators

(a) High-Dose Atorvastatin after Stroke or Transient Ischemic Attack

(a) N Engl J Med 2006;355:549-59.

Cerebrovascular disease

To test whether 5 years of treatment with 80mg of atorvastatin would reduce the risk of stroke in patients who had had a stroke or TIA within the previous six months.

Study design
Randomised, double-blind, placebo-controlled

4.9 years

4731 patients (male and female) 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.

Treatment regimen
Atorvastatin 80 mg per day, or placebo

Concomitant therapy

The primary end point was a first nonfatal or fatal stroke. The mean LDL cholesterol level during the trial was 73 mg per deciliter (1.9 mmolper 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.