Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
Summary
A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.
Timeline
- Start
- 2007-01
- Primary completion
- 2008-07
- Completion
- 2008-07
Outcome
Met primary endpoint
registry analysis (unspecified test); Atorva 10 mg vs EZ/Simva 10 mg/20 mg; p <0.001; Mean Difference (Final Values) -13.1 (95% CI -16.5 to -9.8); ANOVA; NCT00409773 ↗
registry analysis (unspecified test); EZ/Simva 10 mg/40 mg vs Atorva 40 mg; p <0.001; Mean Difference (Final Values) -8.0 (95% CI -11.3 to -4.6); ANOVA; NCT00409773 ↗
paper Ezetimibe/simvastatin produced significantly greater reductions in evaluated lipids than atorvastatin for most prespecified dose comparisons. PMID 22108151 ↗
Publications
- Rosen JB, Ballantyne CM, Hsueh WA, Lin J, Shah AK, Lowe RS, Tershakovec AM. Influence of metabolic syndrome factors and insulin resistance on the efficacy of ezetimibe/simvastatin and atorvastatin in patients with metabolic syndrome and atherosclerotic coronary heart disease risk. Lipids Health Dis. 2015 Sep 4;14:103. doi: 10.1186/s12944-015-0075-5.
- Robinson JG, Ballantyne CM, Hsueh W, Rosen J, Lin J, Shah A, Lowe RS, Hanson ME, Tershakovec AM. Achievement of specified low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol apolipoprotein B, and high-sensitivity C-reactive protein levels with ezetimibe/simvastatin or atorvastatin in metabolic syndrome patients with and without atherosclerotic vascular disease (from the VYMET study). J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 10 mg | — |
| Subject | Atorvastatin | Small molecule | 20 mg | — |
| Subject | Atorvastatin | Small molecule | 40 mg | — |
| Subject | Ezetimibe | Unknown | 10 mg | — |
| Subject | Simvastatin | Small molecule | 20 mg | — |
| Subject | Simvastatin | Small molecule | 40 mg | — |