Abstract 3730: Ezetimibe/simvastatin More Favorably Influences Lipoprotein/ Apolipoprotein Ratios than Atorvastatin Monotherapy in Patients with Type 2 Diabetes
BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) are at high risk for coronary heart disease (CHD). LDL-C levels are recommended as the primary guide for cholesterol-lowering therapy in patients at risk, including those with diabetes. However, high non-HDL-C and low HDL-C are also risk factors for CHD. A variety of lipoprotein and apolipoprotein ratios have been proposed that may reflect the balance of cholesterol delivery and removal at the arterial wall, and provide a supplemental assessment of CHD risk.
METHODS: This randomized, double-blind, parallel-group study enrolled T2DM patients with LDL-C ≥100 mg/dL for 6-week treatments either with the usual daily starting doses of atorvastatin (A) (10 or 20 mg) or ezetimibe/simvastatin (E/S) 10/20mg, or with alternative starting doses: A 40 mg, E/S 10/40 mg. The primary efficacy endpoint was % change from baseline in LDL-C. Lipoprotein/ apolipoprotein ratio exploratory endpoints (LDL/HDL, ApoB/ApoA-I, non-HDL-C/HDL-C and Total C/HDL-C) were analyzed using an ANOVA model with terms for treatment and baseline LDL-C stratum.
RESULTS: Efficacy results were based on 1198 patients with sufficient data among 1229 patients randomized. Baseline characteristics were comparable. As reported elsewhere, E/S was more effective at lowering LDL-C than A at each dose comparison, P<0.001. Effects on the prespecified ratios are shown in the table⇓; E/S produced significantly greater reductions in each ratio at each dose comparison.
CONCLUSION: Treatment with E/S resulted in greater improvements in each lipoprotein/apolipoprotein ratio examined compared with treatment with A at all usual and alternative starting doses compared.