Lipid-altering efficacy of switching to ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg in high-risk patients with and without metabolic syndrome

Abstract

Metabolic syndrome (MetS) is a clustering of atherosclerotic coronary heart disease risk factors. This post-hoc analysis compared the effects of switching to ezetimibe/simvastatin 10/20 mg or rosuvastatin 10 mg in a cohort of 618 high-risk hypercholesterolaemic patients with (n=368) and without (n=217) MetS who had previously been on statin monotherapy. Patients were randomised 1:1 to double-blind ezetimibe/simvastatin 10/20 mg or rosuvastatin 10 mg for 6 weeks. Least squares mean percent change from baseline and 95% confidence intervals in lipid efficacy parameters were calculated for the population and within subgroups. Treatment with ezetimibe/simvastatin was significantly more effective than rosuvastatin at lowering low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, and apolipoprotein B (all p<0.001). No significant differences in treatment effects were seen between the presence and absence of MetS. In this post-hoc analysis of high-risk hypercholesterolaemic patients the lipid-reducing effects of ezetimibe/simvastatin or rosuvastatin were not altered significantly by the presence of MetS.

The efficacy and safety of ezetimibe/simvastatin combination compared with intensified lipid‐lowering treatment strategies in diabetic subjects with and without metabolic syndrome

“…These were consistent with the expectations for the dyslipidaemia profiles in patients with diabetes and/or the MetS. Of note, greater lipid responses and/or target attainment were achieved with the combination of ezetimibe/simvastatin treatment regimen compared with statin monotherapy in all of the previous studies as well as the current analysis [14][15][16], supporting the premise that it may be necessary to use combination therapies or to intensify current statin therapy in patients with elevated cardiometabolic risk in order to achieve recommended treatment targets [6][7][8]. Whether these baseline differences impacted the magnitude of change in the lipids is unknown.…”

“…Moreover, these characteristics were generally similar to the baseline characteristics observed in subjects with MetS included in other post hoc analyses that assessed ezetimibe/simvastatin 10/20 mg versus rosuvastatin 10 mg [14]. The safety and tolerability profiles were generally similar between treatments in both subgroups.…”

“…The safety and tolerability profiles were generally similar between treatments in both subgroups. In contrast, the subjects with MetS in the analysis by Averna et al experienced slightly greater changes in lipids compared with subjects without MetS, although these differences were not statistically significantly different [14]. These were consistent with the expectations for the dyslipidaemia profiles in patients with diabetes and/or the MetS.…”

Ezetimibe combined with standard diet and exercise therapy improves insulin resistance and atherosclerotic markers in patients with metabolic syndrome

“…Several clinical studies have reported that combination therapy with ezetimibe and statin strongly reduces LDL-c, remnant-like particle cholesterol (RLP-c) and triglycerides, and increases high-density lipoprotein cholesterol (HDL-c) in patients with metabolic syndrome or diabetes2–10. In particular, in patients with metabolic syndrome, combination therapy with ezetimibe and mild statin was significantly more effective than strong statin alone in reducing LDL-c11. It has also been reported that ezetimibe has some pleiotropic effects, such as improvement of inflammatory markers, insulin sensitivity, liver dysfunction, endothelial function and metabolic disorders12–15.…”

Adjuvant Therapy for Incremental Low-Density Lipoprotein Cholesterol Reduction With Ezetimibe

“…10 In patients with metabolic syndrome (with or without diabetes) and high LDL-C levels, ezetimibe (combined with simvastatin, atorvastatin, or fenofibrate or alone) has demonstrated beneficial changes in lipid profiles (total cholesterol, LDL-C, apolipoproteins A-I and A-II, triglycerides, and high-sensitivity C-reactive protein) in a similar magnitude than in patients without metabolic syndrome. [19][20][21][22][23][24][25][26][27][28][29][30] These trials are included in meta-analysis concerning cholesterol-lowering interventions in all chronic situations, in high-risk patients with or without LDL-C elevation, in patients with related disease, and in patients with renal insufficiency (on hemodialysis or transplant) and niacin in all types of patients (summarized in Table 1). 10-31…”