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Randomized Controlled Trial Multicenter Study
High-dose simvastatin for aneurysmal subarachnoid hemorrhage: multicenter randomized controlled double-blinded clinical trial.
- George K C Wong, David Y C Chan, Deyond Y W Siu, Benny C Y Zee, Wai S Poon, Matthew T V Chan, Tony Gin, Michael Leung, and HDS-SAH Investigators.
- From the Division of Neurosurgery (G.K.C.W., D.Y.C.C., W.S.P.), Department of Anaesthesia and Intensive Care (M.T.V.C., T.G.), Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China; Department of Diagnostic Imaging, Kwong Wah Hospital, Hong Kong, China (D.Y.W.S.); and Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China (B.C.Y.Z., M.L.). georgewong@surgery.cuhk.edu.hk.
- Stroke. 2015 Feb 1;46(2):382-8.
Background And PurposeExperimental 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.MethodsThe 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.ResultsNo 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).ConclusionsHigh-dose simvastatin treatment should not be prescribed routinely for aneurysmal subarachnoid hemorrhage.Clinical Trial Registration Urlhttp://www.clinicaltrials.gov. Unique identifier: NCT01077206.© 2014 American Heart Association, Inc.
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