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Amerenco P, et al. High-dose atorvastatin after stroke or transient ischemic stroke. N Engl J Med 2006;355(6):549-59. PubMed
| Study Design |
Prospective, Randomized, Multicenter, Double Blind, Placebo Controlled Trial |
| Sample Size |
n = 4,731 |
| Patients |
Patients who had had a stroke or TIA within one to six months before study entry, had LDL-c levels of 100 to 190 mg per deciliter (2.6 to 4.9 mmol per liter), and had no known CHD. |
| Groups |
Atorvastatin 80 mg daily or Placebo |
| Follow Up |
Median of 4.9 years |
| Results |
- During a median follow-up of 4.9 yrs, 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 HR, 0.84; 95% Cl, 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 ARR of major CV events was 3.5% (HR, 0.80; 95% CI, 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.
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| Conclusion |
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 |
NCT00147602 |
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