Simvastatin in the acute phase of ischemic stroke: a safety and efficacy pilot trial.

Author(s): Montaner J, Chacon P, Krupinski J, Rubio F, Millan M, Molina CA, Hereu P, Quintana M, Alvarez-Sabin J

Affiliation(s): Neurovascular Research Laboratory, Neurovascular Unit, Hospital Universitario Vall d'Hebron, Barcelona, Spain. 31862jmv@comb.es

Publication date & source: 2008-01, Eur J Neurol., 15(1):82-90. Epub 2007 Dec 7.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Although statins are being used for secondary prevention of ischemic stroke, recent experimental data have shown new pleiotropic effects of these drugs responsible for their role in neuroprotection. We conducted a pilot, double-blind, randomized, multicenter clinical trial to study for the first time safety and efficacy of simvastatin in the acute phase of ischemic stroke. Simvastatin/placebo was given at 3-12 h from symptom onset to 60 patients with cortical strokes. Efficacy on the evolution of several inflammation markers [interleukin (IL)-6, IL-8, IL-10, monocyte chemoattractant protein-1, intercellular adhesion molecule-1, vascular cell adhesion molecule-1, C-reactive protein, sApo/Fas, tumor necrosis factor-alpha, E-selectin, L-selectin and nitrites+nitrates] and neurological outcome was evaluated at baseline, day 1, 3, 5, 7 and 90. No differences were found amongst the biomarkers studied regarding treatment allocation. Although simvastatin patients improved significantly by the third day (46.4% vs. 17.9%, P = 0.022), a non-significant increase in mortality and greater proportion of infections (odds ratio 2.4, confidence interval 1.06-5.4) in the simvastatin group were the main safety concerns. Therefore, a larger clinical trial is needed to confirm the net benefit of this therapeutic approach.