A randomized, double-blind, placebo-controlled pilot study of simvastatin in aneurysmal subarachnoid hemorrhage.
OBJECTIVE
Studies suggest statins ameliorate aneurysmal subarachnoid hemorrhage (SAH)-induced cerebral vasospasm and ischemic complications. We tested safety and feasibility of simvastatin 80 mg/d for vasospasm prevention in SAH patients.


METHODS
Thirty-nine statin-naïve Fisher grade 3 SAH subjects were double-blind randomized to receive simvastatin 80 mg/d (n=19) or placebo (n=20), stratified by Hunt and Hess grade. Primary end points were death and drug morbidity.


RESULTS
Mortality was 3/20 in the placebo and 0/19 in the simvastatin group. Study drug was withdrawn in 1 subject in each treatment group for reversible liver enzyme or creatine phosphokinase elevation. Angiographically-confirmed vasospasm occurred in 8/20 placebo and 5/19 simvastatin-treated subjects. Vasospasm-related ischemic infarcts developed in 5/20 placebo and 2/19 simvastatin-treated subjects.


CONCLUSIONS
Simvastatin for the prevention of delayed cerebral ischemia is safe and feasible after SAH. A larger study is needed to test its efficacy.
Chou
Sherry H-Y
SH
Smith
Eric E
EE
Badjatia
Neeraj
N
Nogueira
Raul G
RG
Sims
John R
JR
Ogilvy
Christopher S
CS
Rordorf
Guy A
GA
Ayata
Cenk
C
D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D019821:Simvastatin / Q000627:therapeutic use*; D013345:Subarachnoid Hemorrhage / Q000150:complications / Q000188:drug therapy*; D020301:Vasospasm, Intracranial / Q000209:etiology / Q000517:prevention & control*
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin