SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial

• 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 2.6 to 4.9 mmol per litre, and had no known coronary heart disease were randomly assigned to double-blind treatment with 80 mg of atorvastatin per day or placebo
• primary end point was a first nonfatal or fatal stroke
• there was a median follow-up of 4.9 years
• trial results
  • mean LDL cholesterol level during the trial was1.9 mmol per litre among patients receiving atorvastatin and 3.3 mmol per litre among patients receiving placebo
  • 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)
    • atorvastatin group had 218 ischemic strokes and 55 hemorrhagic strokes
    • the placebo group had 274 ischemic strokes and 33 hemorrhagic strokes
    • 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)
    • 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
    • NNT
      • 46 patients required to be treated for 5 years in order to prevent one stroke (95% CI 24-243)
      • 29 patients required to be treated for 5 years in order to prevent one major cardiovascular event (95% CI 18-75)
      • 32 patients required to be treated for 5 years in order to prevent one revascularization procedure (95% CI 22-59)
  • the study authors concluded that, 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

Reference:

1. N Engl J Med. 2006 Aug 10;355(6):549-59