Abstract 437: Simvastatin/Ezetimibe 20/10 mg Versus Atorvastatin 20 mg in Patients with Type 2 Diabetes: Results of Single-Center, Randomized Controlled Trial
Introduction Though the efficacy on traditional lipid parameters of simvastatin/ezetimibe and atorvastatin has been studied extensively, ApoB/ApoA1 ratio which has better predictive value for cardiovascular event has not been compared as a primary endpoint in these two treatment groups before, especially in diabetes.
Methods This study was a single center, open label, randomized phase 4 study to compare the efficacy and safety of simvastatin/ezetimibe 20/10mg versus atorvastatin 20mg once daily in subjects with type 2 diabetes. One hundred thirty-two well controlled diabetic patients (HbA1C <8.5%) with high LDL cholesterol levels (≥ 100mg/dL) were randomized to two groups. The primary endpoint was the difference in percent change of ApoB/ApoA1 ratio at 12 weeks and secondary endpoints were changes in conventional lipid profiles and apolipoproteins.
Results In total, 132 patients (66 for each group; 60 males; mean age, 64.6±7.6 years) were enrolled and 125 patients were included in the full analysis set (62 for simvastatin/ezetimibe; 63 for atorvastatin). Baseline characteristics including lipid profiles were comparable between two groups. After 12 weeks of treatment ApoB/ApoA1 ratio was significantly reduced in both groups, however the differences of % changes between two groups were statistically not significant (-38.1±17.9% vs. -34.2±16.2%, p=0.279) and the changes in conventional lipid profiles including total cholesterol, LDL cholesterol and triglyceride also showed no significant difference. However, HDL cholesterol and ApoA1 levels increased significantly in the simvastatin/ezetimibe group, whereas decreased in the atorvastatin group (HDL cholesterol 4.2±12.7% vs. -0.2±14.8% and ApoA1 2.8±10.0% vs. -1.8±9.8%, p=0.041 and 0.002). In per-protocol analysis, improvement of ApoB/ApoA1 was significantly greater in the simvastatin/ezetimibe group (-42.3±11.9% vs. -36.5±14.1%, p=0.031). The changes of HOMA index and hsCRP were comparable between two groups in full analysis set. But in per-protocol analysis, HOMA index and hsCRP decreased in the simvastatin/ezetimibe group whereas increased in the atorvastatin group although there was no statistic significance. The frequency of adverse reaction was comparable between two groups.
Conclusion Based on the results of this randomized controlled trial, simvastatin/ezetimibe 20/10mg might be preferable to atorvastatin 20mg for management of dyslipidemia in the patients with type 2 diabetes.
- © 2012 by American Heart Association, Inc.