Abstract
PurposeThis post hoc analysis assessed switching to ezetimibe/simvastatin 10/20 mg vs doubling the baseline statin dose to simvastatin 40 mg or atorvastatin 20 mg or switching to rosuvastatin 10 mg in subgroups of obese (BMI ≥30 kg/m2) and non-obese (BMI <30 kg/m2) diabetic subjects.MethodsThis was a randomized, double-blind, 12-week study of adults 18–79 years with cardiovascular disease with low-density lipoprotein cholesterol (LDL-C) ≥70 and ≤160 mg/dl. Percent change in LDL-C and other lipids was estimated.ResultsIn obese subjects (n = 466), percent changes in LDL-C and most other lipids were greater with ezetimibe/simvastatin vs doubling the baseline statin dose or switching to rosuvastatin. In non-obese subjects (n = 342), percent changes in LDL-C, total cholesterol, non-HDL-C, Apo B and Apo A-I were greater with ezetimibe/simvastatin vs doubling the baseline statin dose or switching to rosuvastatin; and treatment with ezetimibe/simvastatin resulted in greater changes in triglycerides vs rosuvastatin and HDL-C vs doubling the baseline statin dose. The safety profiles were generally similar.ConclusionsRegardless of baseline obesity status, switching to ezetimibe/simvastatin was more effective at reducing LDL-C, total cholesterol, non-HDL-C, and Apo B vs doubling the baseline statin dose to simvastatin 40 mg or atorvastatin 20 mg or switching to rosuvastatin 10 mg.
Highlights
The presence of diabetes and obesity is associated with an increased risk of cardiovascular disease (CVD) [1,2,3]
Efficacy endpoints In this post hoc analysis, the primary evaluation was the consistency of the treatment effect between ezetimibe/ simvastatin 10/20 mg vs. doubling the baseline statin dose across subgroups and the secondary evaluation was the consistency of the treatment effect between ezetimibe/simvastatin 10/20 mg vs. rosuvastatin 10 mg across subgroups
There was a higher proportion of Hispanics or Latinos in the non-obese subgroup (23.2% in the doubling statin group, 24.2% in the rosuvastatin 10 mg group and 31.9% in the ezetimibe/simvastatin 10/20 mg group) compared with the obese subgroup (9.7% in the doubling statin group, 10.5% in the ezetimibe/simvastatin 10/20 mg group and 11.5% in the rosuvastatin group)
Summary
In non-obese subjects (Figure 4b) changes in triglycerides were numerically greater in the ezetimibe/simvastatin 10/ 20 treatment group compared with the rosuvastatin 10 mg group, while the subjects whose baseline statin dose was doubled showed similar decreases to subjects treated. In non-obese subjects, changes in HDL-C were similar between treatment groups, and increases in Apo A-I were greater in the ezetimibe/simvastatin 10/20 mg vs the doubling the baseline statin dose group (Figure 4b). In both obese and nonobese subjects changes in hs-CRP were numerically greater with rosuvastatin 10 mg vs ezetimibe/simvastatin 10/20 mg (Figures 4a and 4b). No clinically meaningful differences in change from baseline in blood pressure between the treatment groups were observed in any subgroup
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