Efficacy and Safety of Ezetimibe/Simvastatin Compared with Intensified Lipid-lowering Treatment in Diabetic Subjects With and Without Metabolic Syndrome

Abstract

age with CVD and diabetes mellitus with low-density lipoprotein cholesterol (LDL-C) $70 and #160 mg/dL. The percent change in LDL-C and other lipids was estimated within each subgroup separately with the use of a constrained longitudinal data analysis model with terms for treatment, time, time-by-treatment interaction, stratum, and time-by-stratum interaction. Safety was also assessed. Results: In obese subjects, percent changes in LDL-C and other lipids were greater with E/S compared with doubling the baseline statin dose or switching to rosuvastatin, except HDL-C and Apo A1. In nonobese subjects, percent changes in LDL-C, total cholesterol non-HDL-C, Apo B and Apo A1 were greater with E/S compared with doubling the baseline statin dose or switching to rosuvastatin. Also in nonobese subjects, treatment with E/S resulted in greater reductions in triglycerides compared with rosuvastatin and greater changes in HDL-C vs doubling the baseline statin dose (Table 1). There were no clinically significant safety concerns in any of the treatment subgroups. Conclusions: Regardless of baseline body mass index, in this population of high-risk diabetic subjects, switching to E/S 10/20 was more effective at reducing LDL-C, total cholesterol and Apo B compared with doubling the baseline statin dose to simvastatin 40 mg or atorvastatin 20 mg or switching to rosuvastatin 10 mg. The safety