Comparison of Efficacy and Safety of Statin-ezetimibe Combination Therapy With Statin Monotherapy in Patients With Diabetes: A Meta-analysis of Randomised Controlled Studies
Abstract Background and aims: Diabetic dyslipidaemia is characterised by very high levels of triglycerides, low high-density lipoprotein (HDL), and slightly elevated low-density lipoprotein (LDL) cholesterol. Additionally, the potentially increased risk of morbidity and mortality following atherosclerotic cardiovascular diseases should be considered in the treatment of dyslipidaemia in patients with diabetes. Methods: We performed a meta-analysis of the published data to compare the effects of statin-ezetimibe combination therapy and statin monotherapy on lipid and glucose parameters in patients with diabetes. Additionally, the safety based on the reported adverse events was compared between the two groups. Results: Seventeen articles were included in this meta-analysis. In the efficacy assessment, the combination treatment afforded a significantly greater reduction in LDL cholesterol than did statin monotherapy (standard difference in means = 0.894; 95% confidence interval 0.598–1.191). A significantly greater improvement effect was observed in the levels of HDL cholesterol, total cholesterol, triglyceride, and apolipoprotein B, but not apolipoprotein A1, with combination therapy than with statin monotherapy. Additionally, combination therapy reduced the fasting blood glucose levels more significantly than did statin monotherapy. In terms of safety, there were no significant differences in treatment-related adverse events between the two treatments. Conclusions: Statin-ezetimibe combination therapy appears to enhance LDL cholesterol and other lipid levels without an increased risk of adverse events, compared with statin monotherapy. The present meta-analysis presents valid evidence for appropriate drug regimens to treat dyslipidaemia in patients with diabetes.