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Randomized Controlled Trial
. 2013 Jul 16:12:103.
doi: 10.1186/1476-511X-12-103.

Consistency of effect of ezetimibe/simvastatin compared with intensified lipid-lowering treatment strategies in obese and non-obese diabetic subjects

Jeffrey B Rosen, Jose G Jimenez, Valdis Pirags, Hella Vides, Rachid Massaad, Mary E Hanson, Philippe Brudi, Joseph Triscari
Randomized Controlled Trial

Consistency of effect of ezetimibe/simvastatin compared with intensified lipid-lowering treatment strategies in obese and non-obese diabetic subjects

Jeffrey B Rosen et al. Lipids Health Dis. .

Abstract

Purpose: This 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.

Methods: This 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.

Results: In 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.

Conclusions: Regardless 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.

Trial registration: ClinicalTrials.gov NCT00862251.

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Figures

Figure 1
Figure 1
Flow of subjects through the study.
Figure 2
Figure 2
Least squares mean percent change from baseline in LDL-C in obese and non-obese subjects after 6 weeks of treatment. Bars represent standard error. (FAS population).
Figure 3
Figure 3
Percent of subjects achieving specified targets after 6 weeks of treatment (FAS population).
Figure 4
Figure 4
Least squares mean percent change from baseline in lipids, lipoproteins and hs-CRP after 6 weeks of treatment. Bars represent standard error. (FAS population). a. Obese subjects. b. non-obese subjects.
Figure 5
Figure 5
Least squares mean percent change from baseline in lipid ratios after 6 weeks of treatment. Bars represent standard error. (FAS population). a. obese subjects. b. non-obese subjects.
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