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Lipid-altering efficacy and safety of ezetimibe/simvastatin versus atorvastatin in patients with hypercholesterolemia and the metabolic syndrome (from the VYMET study)
The American Journal of Cardiology, 06/22/09

Robinson JG et al. – Ezetimibe/simvastatin (E/S) is more likely to result in lipid treatment endpoints than atorvastatin and was generally well tolerated at the compared doses.

Methods

• Double-blind, randomized, 6-week study of lipid-lowering efficacy of E/S 10/20 mg vs atorvastatin 10 or 20 mg, and E/S 10/40 mg vs atorvastatin 40 mg
• Subjects: 1,128 pts with hypercholesterolemia and the metabolic syndrome
• Primary endpoint: percentage of change from baseline in low-density lipoprotein (LDL) cholesterol
• Additional endpoints: changes in other lipids, lipoprotein ratios, high-sensitivity C-reactive protein, and attainment of pre-specified lipid levels

Results

• Significantly greater improvements in levels of LDL cholesterol, non–high-density lipoprotein cholesterol, apolipoprotein B, and lipid/lipoprotein ratios with E/S vs atorvastatin at all dose comparisons
• Attainment of prespecified LDL cholesterol and non–high-density lipoprotein cholesterol levels significantly greater with E/S vs atorvastatin at all dose comparisons
• High-density lipoprotein cholesterol increases significantly greater with E/S 10/20 mg vs atorvastatin 10 mg and E/S 10/40 mg vs atorvastatin 40 mg
• Changes in triglycerides, very low-density lipoprotein cholesterol, and high-sensitivity C-reactive protein similar for both treatments
• Low incidence of liver, muscle, and gastrointestinal-, hepatitis- and allergic reaction/rash-related adverse events, generally similar to those in previous studies of E/S and/or atorvastatin