Published Online
on July 24, 2008

A more recent version of this article appeared on October 1, 2008

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Submitted on January 15, 2008
Accepted on February 15, 2008

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

Sherry H.-Y. Chou MD, CM; Eric E. Smith MD, MPH, FRCPC; Neeraj Badjatia MD, MSc; Raul G. Nogueira MD; John R. Sims II MD; Christopher S. Ogilvy MD; Guy A. Rordorf MD; and Cenk Ayata MD^*

From the Department of Neurology (S.H.-Y.C.), Brigham and Women's Hospital, Harvard Medical School, and the Departments of Neurology (E.E.S., R.G.N., J.R.S., G.A.R., C.A.), Radiology (R.G.N., J.R.S., C.A.), and Neurosurgery (C.S.O.), Massachusetts General Hospital, Harvard Medical School, Charlestown, Mass; and the Department of Neurology and Neurosurgery (N.B.), Columbia University College of Physicians and Surgeons, New York.

^* To whom correspondence should be addressed. E-mail: cayata{at}partners.org.

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 Study drug was withdrawn in 1 subject in each treatment group for reversible liver enzyme or creatine phosphokinase elevation.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.

Key words: vasospasm • delayed cerebral ischemia • clinical trial

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