However, the high-dose regimen was associated with significantly more frequent adverse events (8.1% versus 5.8%), higher rate of discontinuation of treatment due to treatment-related adverse events (7.2% versus 5.3%), and greater incidence of persistent elevations in liver enzymes (1.2% versus 0.2%). 1 In the Treating to New Targets (TNT) trial, high-dose atorvastatin significantly reduced total cholesterol and triglycerides levels compared with the 10-mg dose. There is randomized evidence that atorvastatin at 80 mg/day provides significant reductions in the risks of cardiovascular events and stroke beyond that afforded by a 10-mg dose in patients with coronary disease. The doseвЂ“response analyses in the North Dublin Population Stroke Study were exploratory, and the observed association between atorvastatin's dose and outcome was largely driven by worse outcome in atorvastatin-untreated patients. Although the Medical Research Council/British Heart Foundation Heart Protection Study (HPS) showed no obvious reduction in stroke recurrence among those with a history of stroke with simvastatin at 40 mg/day, these results do not necessarily imply that atorvastatin in doses <80 mg/day would have been less effective in SPARCL given the differences in medical comorbidities between HPS and SPARCL participants. It is, however, unclear in the absence of randomized comparisons in patients with stroke if lower doses of atorvastatin are equally or less effective than the high-dose regimen. The SPARCL study reliably showed that high-dose atorvastatin at 80 mg/day reduces the risk of recurrent stroke and other cardiovascular events in patients with stroke without known coronary disease, classified as having large-vessel disease, small-vessel disease, or stroke of unknown cause. Should all patients with stroke be started on high-dose statins? Is there an association between dose and response? The answers are presently unknown. In another pilot study, randomization to simvastatin at 40 mg/day within 12 hours and for 72 hours after stroke onset was associated with improvement in neurological function by Day 3 compared with placebo, but this did not persist at Day 90. However, patients in SPARCL began their treatment within 30 to 60 days after the stroke. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial, while it demonstrated the benefit of high-dose atorvastatin for secondary stroke prevention, it did not provide evidence of neuroprotective benefits. Few randomized trials of statins in acute stroke have been performed with inconclusive results. Is there sufficient evidence that statins have neuroprotective effects in patients with stroke? First, we point out that interpretation of clinical studies linking statins to improved stroke outcome, which were mostly retrospective, is difficult due to variability in patient population and follow-up periods and insufficient power to fully adjust for confounding variables. So, let us address the following questions. Our experts firmly hold opposing and widely divergent views. This prompted an ongoing debate as to whether statins should be used in every patient with ischemic stroke regardless of the stroke mechanism and whether maximum doses should be used on initiation of therapy. Observational studies show that statin use is associated with improved outcome in patients with ischemic stroke, presumably a result of the pleiotropic effects suggested in animal studies. These are seen at the highest doses with a doseвЂ“response effect. Statins exert neuroprotective, microvascular, and anti-inflammatory beneficial effects in animal stroke models, independent of their lipid-lowering capabilities. Customer Service and Ordering Information.Stroke: Vascular and Interventional Neurology.Journal of the American Heart Association (JAHA).Circ: Cardiovascular Quality & Outcomes.Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB).

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