Efficacy and Safety of EzetimibeSimvastatin Co- Administered with Fenofibrate in Mixed Hyperlipidemic Patients with Metabolic Syndrome.

Autor: Blas Gil-Extremera, Gustavo Mendez, Michelle Zakson, Alan Meehan, Arvind Shah, Jianxin Lin, Yale Mitchel
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Zdroj: Metabolic Syndrome & Related Disorders; Dec2007, Vol. 5 Issue 4, p305-314, 10p
Abstrakt: BackgroundWe compared the lipid-altering effects of ezetimibesimvastatin (EZESIMVA) co-administered with fenofibrate (FENO) in mixed hyperlipidemic patients with (MetS) versus those without MetS.MethodsA total of 611 patients, 20 to 79 years old, with LDL-C 130–220 mgdL (100–180 mgdL for patients with type 2 diabetes [T2D]), triglycerides (TG) 150–500 mgdL, and no history of CHD or other CHD risk equivalent disease (except for T2D), were randomized in a 1333 ratio into one of the following four treatments for 12 weeks placebo; EZESIMVA 1020 mg; FENO 160 mg; or EZESIMVAFENO. MetS status was determined in 607 patients using National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria. Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non–HDL-C, total cholesterol (TC), TG, apolipoproteins A-I and B, and C-reactive protein was assessed in these patients with or without MetS. The primary objective was to evaluate the lipid-altering efficacy of EZESIMVAFENO versus FENO monotherapy in the MetS versus non-MetS subgroups.ResultsAt baseline, patients with MetS had a higher body mass index (BMI) and TG and lower HDL-C. At Week 12, treatment with EZESIMVA, FENO, and EZESIMVA FENO led to similar improvements in lipid parameters in patients with MetS compared to those without MetS. Treatment with EZESIMVA FENO and FENO also led to an increase in LDL particle-size pattern after 12 weeks in both subgroups of patients.ConclusionsThis post-hoc analysis suggested that co-administration of EZESIMVAFENO had consistent benefits on the lipid profile in mixed hyperlipidemic patients with or without MetS. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index