Title : Quantitative evaluation of safety ofstatins

November '09

Statins have well-documented adverse effects related to two system organ classes (SOCs), musculoskeletal and renal. In this paper we wish to statistically compare adverse events (AEs) that belong to these two SOCs across three Statins: Atorvastatin, Rosuvastatin and Simvastatin, using the United States Food and Drug Administration (US FDA) adverse events reporting system (AERS) data from the first quarter of 2004 through the second quarter of 2008. The objective is to investigate if the reported incidence of AEs in each of the 2 SOCs varies across the 3 Statins. In order to do this comparison, we select one widely used brand of each of the 3 Statins. We evaluate statistical significance of differences in reported incidences using a linear model.