The Atorvastatin During Ischemic Stroke Study: A Pilot Randomized Controlled Trial

Clinical Neuropharmacology, 07/19/2011

Muscari A et al. – This pilot study was unable to show any short–term benefit of atorvastatin during the acute phase of ischemic stroke. However, it suggested a possible favorable functional effect at 3 months in the least severe strokes, which could be the primary end point for a future multicenter trial.

Methods

  • 62 patients with ischemic stroke, aged 75.3 (SD, ±11.9) years (68% women), were randomized into a placebo (n = 31) and an atorvastatin 80 mg/d (n = 31) group.
  • Double–blind treatment lasted 7 days.
  • Primary end point was a decrease of National Institutes of Health Stroke Scale score of 4 points or higher after 7 days.
  • Infarct volume measured on computed tomographic scan after 3 days and a modified Rankin Scale of less than 2 at 3 months were secondary end points.

Results

  • There was no difference in the primary end point between the 2 groups (odds ratio, atorvastatin vs placebo, 0.74; 95% confidence interval, 0.26–2.17).
  • Infarct volume also was similar in the 2 groups.
  • Instead, there were more patients with modified Rankin Scale of less than 2 at 3 months in the atorvastatin than in the placebo group (adjusted odds ratio, 6.7; 95% confidence interval, 1.0–45.0; P = 0.05).
  • This prevalence concerned only the subgroup with mild strokes (National Institutes of Health Stroke Scale, ≤10; 53.8% vs 15.4%, respectively; P = 0.04).
  • Atorvastatin was well tolerated.

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