Statins and poststroke intracerebral hemorrhage: Concern but increasing reassurance

Post hoc analyses of data from randomized controlled trials can generate useful hypotheses, but need to be considered exploratory. When conducted, such evaluations should adhere to specified criteria and test for a treatment by subgroup interaction for the trial's primary endpoint.1 The best way to proceed if unexpected but potentially important outcomes occur is less clear. Concern that treatment with HMG-CoA reductase inhibitors (i.e., statins) might increase the risk of poststroke intracerebral hemorrhage (ICH) arose from an unanticipated observation in the Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) trial.2 In SPARCL, patients who had a noncardioembolic ischemic stroke (67%) or TIA (31%) or hemorrhagic stroke (2%) within the prior 1 to 6 months were randomized to high-dose atorvastatin or placebo. SPARCL found an overall reduction in the risk of the primary outcome (fatal or nonfatal stroke; adjusted hazard ratio [HR] 0.84; 95% confidence interval [CI] 0.71–0.99) despite an increase in hemorrhagic stroke (HR 1.66, 95% CI 1.08–2.55) in the atorvastatin group with statistical heterogeneity based on the type of stroke occurring during the trial (ischemic, hemorrhagic, or unclassified stroke). In addition to atorvastatin treatment, subsequent exploratory analyses using multivariable regression revealed higher hemorrhagic stroke risk in those having a hemorrhagic stroke as the entry event (HR 5.65, 95% CI 2.82–11.30), in men (HR...
Source: Neurology - Category: Neurology Authors: Tags: All Cerebrovascular disease/Stroke, Intracerebral hemorrhage EDITORIALS Source Type: research