Comparison of Effects of Morning Versus Evening Administration of Ezetimibe/Simvastatin on Serum Cholesterol in Patients with Primary Hypercholesterolemia
Annals of Pharmacotherapy, 06/24/2011
Yoon HS et al. – Morning administration of ezetimibe/simvastatin 10 mg/20 mg is noninferior to evening administration with respect to LDL–C– lowering ability.Methods
- In this multicenter, open–label, randomized, 2–sequence, 2–period crossover study, patients with primary hypercholesterolemia randomly received ezetimibe/simvastatin 10 mg/20 mg once daily, either in the morning (within 1 hour of breakfast) or in the evening (within 1 hour of dinner) for 6 weeks.
- Data on 171 patients (87 in the morning administration group and 84 in the evening administration group) were analyzed.
- A significant reduction (p 0.001) in the total cholesterol, triglyceride, high–density lipoprotein cholesterol, LDL–C, apo–lipoprotein B, and high–sensitivity C–reactive protein (hs–CRP) from baseline was achieved after each treatment.
- Noninferiority of morning administration versus evening administration was shown in the percentage reduction of the LDL–C level from baseline (difference, –1.62%; 90% CI –4.94 to 1.70).
- No significant difference was found between groups with respect to the percentage of changes in other lipid parameters from baseline.
- Furthermore, there was no significant difference in the percentage of change in hs–CRP as an antiinflammatory marker between the morning and evening administration groups.
- The frequency of adverse events was similar between groups.