Expanding indications for statins in cerebral ischemia: A quantitative study

Background: New US Food and Drug Administration labeling in 2003 recognizes stroke and evidence of cerebrovascular disease as indicator conditions for initiating statin (simvastatin) therapy, based on results of the Heart Protection Study, thereby extending the indications for statins in stroke beyond current US and European guidelines. Objective: To assess the impact on clinical practice of broadening indications for statins in patients with stroke. Design: Observational study. Setting: University hospital stroke service. Patients: One hundred consecutive patients with ischemic stroke and transient ischemic attack. Interventions: Development and application of algorithms for initiating statin therapy in patients with stroke and transient ischemia abstracted from recent national and international guidelines (National Cholesterol Education Program Adult Treatment Panel III, European Joint Task Force II), Heart Protection Study entry criteria, and Heart Protection Study-based US Food and Drug Administration labeling. Main Outcome Measures: Percentages of patients who met clinical trial-validated and US Food and Drug Administration-approved criteria for initiation of statin therapy. Results: Patient age averaged 74 years (range, 35-96 years); 64% were female, and 74% were white. Stroke sub-type was large-vessel atherosclerosis in 24%, cardioembolic in 44%, small-vessel atherosclerosis in 22%, and other in 10%. Twenty of 100 patients were already taking statins on admission. Guidelines for definite initiation of statin treatment were met by 48% of patients for the National Cholesterol Education Program III, 38% for the European Joint Task Force II, 92% for the Heart Protection Study, and 100% for the Food and Drug Administration. Conclusions: Most clinically encountered patients with ischemic stroke meet clinical trial-validated criteria for initiation of statin therapy. Rigidly applying current national and international guidelines may deprive up to one half of these patients of advantages of statin therapy.