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Open Access Research

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

Jeffrey B Rosen1*, Jose G Jimenez2, Valdis Pirags3, Hella Vides4, Rachid Massaad5, Mary E Hanson6, Philippe Brudi6 and Joseph Triscari6

Author Affiliations

1 Clinical Research of South Florida, Coral Gables, FL, USA

2 Hospital CIMA San Jose, Escazu, San Jose, Costa Rica

3 University of Latvia, Riga, Latvia

4 Viljandi Hospital, Vildjandimaa, Estonia

5 MSD Belgium, Brussels, Belgium

6 Merck & Co, Inc., Whitehouse Station, NJ, USA

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Lipids in Health and Disease 2013, 12:103  doi:10.1186/1476-511X-12-103

Published: 16 July 2013

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.

Keywords:
Atorvastatin; Ezetimibe; Diabetes; Obesity; Rosuvastatin; Statin