Introduction: Though the efficacy of traditional lipid parameters of simvastatin/ezetimibe and atorvastatin has been studied extensively, ApoB/A1 ratio which has better predictive value for cardiovascular event has not been compared as a primary endpoint in these two treatment groups.
Methods: This study was a single center, open label, randomized controlled trial to compare simvastatin/ezetimibe 20/10mg versus atorvastatin 20mg once daily in subjects with type 2 diabetes. One hundred thirty-two diabetic patients with high LDL cholesterol levels (��� 100mg/dL) were randomized to two groups. The primary endpoint was changes in ApoB/ApoA1 at 12 weeks and secondary endpoints were changes in lipid profiles and apolipoproteins.
Results: In total, 132 patients (66 for each group) were included in the intention-to-treat analysis (60 males; mean age, 64.6짹7.6 years). Baseline characteristics including lipid profiles were comparable between two groups. After 12 weeks of treatment, the changes in total cholesterol, LDL-cholesterol and triglyceride showed no significant difference between two groups. The changes in ApoB/ApoA1 were not significantly different between the simvastatin/ezetimibe and atorvastatin group (-38.2짹17.8% vs. -34.0짹16.2%, p=0.720). However, HDL-cholesterol and ApoA1 levels were significantly increased in the simvastatin/ezetimibe group, whereas decreased in the atorvastatin group (4.3짹12.8% and 3.0짹10.1% vs. -0.4짹15.2% and -2.0짹10.1%, p=0.041 and 0.002). In per-protocol analysis, improvement of ApoB/ApoA1 was significantly greater in the simvastatin/ezetimibe group (-42.3짹11.9% vs. -35.7짹14.6%, p=0.010). The frequency of adverse reaction and the changes in HbA1C and HOMA index were comparable between two groups.
Conclusion: Based on results of this randomized controlled trial, simvastatin/ezetimibe 20/10mg might be preferable to atorvastatin 20mg for management of dyslipidemia in type 2 DM patients.