Safety Profile of High-Dose Statin Therapy in Geriatric Patients with Stroke

Objectives: Use of high-dose statin therapy (HDST) in patients with stroke became standard clinical practice after the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study, in which the mean age of the study population was approximately 63 years. Little data are available on the adverse effects of statins when used in high doses in adults older than 65 years. The objective of this study was to assess the magnitude of adverse effects of HDST in geriatric patients. Methods: This single-center, retrospective, case-control study was conducted at Upstate Medical University, Syracuse, New York. All patients older than 65 years admitted between 2008 and 2011 to the hospital's Upstate Stroke Center with acute stroke were eligible. Electronic medical records of 200 eligible patients were reviewed to collect demographic, clinical, and laboratory data. Patients on HDST (cases) were compared with those on low doses (controls) using the chi(2), Fisher exact (two-sided), and Student t tests. Results: One hundred cases (mean age 80.5 +/- 7.7 years) were compared with 100 controls (mean age 78.9 +/- 6.4 years). Sixty-seven percent were taking simvastatin. Ninety percent of the cases compared with 81% of the controls had ischemic stroke. The prevalence of elevated alanine aminotransferase (13%) and myositis (4%) was significantly higher in the cases than in the controls. Fourteen percent of the cases reported myalgias, 9% had nausea, and 6% had diarrhea. Seventy-three cases had low-density lipoprotein levels <100 mg% and 41% of the cases had mean glycated hemoglobin levels >= 6.5%. Conclusions: The use of HDST in older adult patients with acute stroke is associated with a significantly increased burden of liver enzyme elevation and myalgias.