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Statins Effective for Treating Acute Ischemic Stroke: Presented at ESC

By Michael J. Worthington

MANNHEIM-HEIDELBERG, GERMANY -- May 18, 2004 -- Treatment with statins initiated in the acute phase of ischemic stroke may improve neurological outcomes, according to researchers reporting the findings here on May 14^th at the 13^th European Stroke Conference.

Recent evidence shows that statins have pleiotropic effects beyond their lipid-lowering effects, said Dr. Julio Montaner, Neurovascular Research Laboratory, Hospital Vall d'Hebron, Barcelona, Spain. Animal studies have shown that statins prevent against stroke in stroke-prone hypertensive rats (Kawashima, et al. Stroke. 2003 Jan;34(1):157-163) and reduce the extent of damage when given within 48 hours after a stroke (Sironi, et al. Arterioscler Thromb Vasc Biol. 2003 Feb 1;23(2):322-327).

To test the efficacy and safety of simvastatin for treatment of acute stroke and to assess surrogate markers that may point to the mechanism of benefit, Dr. Montaner and colleagues conducted the pilot MISTICS (Markers of Inflammation in Simvastatin Treatment of Ischemic Cortical Stroke) trial.

They enrolled 60 patients with ischemic stroke (3 to 6 hours after onset) with cortical involvement and a National Institutes of Health Stroke Score (NIHSS) of 6 to 20. Patients were randomized to treatment with simvastatin or placebo. The initial dose of simvastatin was 40 mg given 3 to 6 hours after stroke onset (emergency setting), lowered to 20 mg for the acute phase (7 days), and maintained during the subacute phase (3 months).

The researchers carried out NIHSS and magnetic resonance imaging assessments at regular time points for 3 months. They also assessed several inflammation markers, including cytokines, adhesion markers, chemokines, and apoptosis.

Patients treated with simvastatin had significantly better neurological outcome compared with placebo by the third day of treatment (46.4% vs. 17.9%, P =.022). Simvastatin was also associated with a smaller decrease in NIHSS score, which was evident at the first day of treatment and maintained throughout the 3 months of follow-up(-9 points simvastatin vs. -5 points placebo at 3 months).

A higher proportion of patients treated with simvastatin showed dramatic improvement in the NIHSS at day 90 (i.e. decrease of <10 points or NIHSS=0; 11 vs. 4 patients, P =.035), Dr. Montaner reported. However, the statin group had a greater incidence of infection (odds ratio 2.4), which was parallel to an increase in the cytokine interleukin-6 (i19.4 vs. 9.0, P =.041, first day).

Although patient numbers were small, those with diabetes appeared to have more significant benefit with simvastatin treatment, Dr. Montaner said.

"This pilot trial shows us that statins are safe drugs for the treatment of acute stroke," Dr. Montaner concluded. "They may offer rapid, short-term efficacy, but unfortunately, the mechanisms remain unknown after this trial. All together, these promising findings encourage us to plan to for a larger clinical trial."


[Presentation title: Safety and Efficacy of Statins in the Acute Phase of Ischemic Stroke: MISTICS Trial]

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