A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Simvastatin in Aneurysmal Subarachnoid Hemorrhage

Abstract

Background and Purpose— 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 Study drug was withdrawn in 1 subject in each treatment group for reversible liver enzyme or creatine phosphokinase elevation.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. Conclusion— Simvastatin for the prevention of delayed cerebral ischemia is safe and feasible after SAH. A larger study is needed to test its efficacy.