BACKGROUND AND PURPOSE: Experimental evidence has indicated the benefits of 
simvastatin for the treatment of subarachnoid hemorrhage. Two randomized 
placebo-controlled pilot trials that used the highest clinically approved dose 
of simvastatin (80 mg daily) gave positive results despite the fact that a lower 
dose of simvastatin (40 mg daily) did not improve clinical outcomes. We 
hypothesized that a high dose of 80 mg of simvastatin daily for 3 weeks would 
reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage 
compared with a lower dose (40 mg of simvastatin daily) and lead to improved 
clinical outcomes.
METHODS: The study design was a randomized controlled double-blinded clinical 
trial. Patients with aneurysmal subarachnoid hemorrhage (presenting within 96 
hours of the ictus) from 6 neurosurgical centers were recruited for 3 years. The 
primary outcome measure was the presence of delayed ischemic deficits, and 
secondary outcome measures included a modified Rankin disability score at 3 
months and an analysis of cost-effectiveness.
RESULTS: No difference was observed between the groups treated with the higher 
dose or the lower dose of simvastatin in the incidence of delayed ischemic 
deficits (27% versus 24%; odds ratio, 1.2; 95% confidence interval, 0.7-2.0; 
P=0.586) or in the rate of favorable outcomes (modified Rankin Scale score, 0-2) 
at 3 months (73% versus 72%; odds ratio, 1.1; 95% confidence interval, 0.6-1.9; 
P=0.770).
CONCLUSIONS: High-dose simvastatin treatment should not be prescribed routinely 
for aneurysmal subarachnoid hemorrhage.
CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique 
identifier: NCT01077206.