Objective: To determine whether co-administering ezetimibe with on-going simvastatin treatment was more effective than placebo plus on-going simvastatin in achieving an LDL-C treatment target of ≤2.60 mmol/l (100 mg/dl) in hypercholesterolemic patients with coronary heart disease (CHD). Methods: Men and women (age ≥18 years) with documented CHD and on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks were recruited for this study. After a 4-week simvastatin 10 or 20 mg plus placebo and diet run-in period, patients were eligible for randomization if LDL-C > 2.60 and ≤4.20 mmol/l and triglycerides (TG) ≤4.00 mmol/l. Eligible patients were randomized to a double-blind comparative study with ezetimibe 10 mg co-administered with on-going simvastatin 10 mg or 20 mg (n = 181) versus placebo to match ezetimibe co-administered with simvastatin 10 mg or 20 mg (n = 191) for 6 weeks. Results: At baseline, mean LDL-C was comparable between the ezetimibe (3.14 mmol/l) and placebo (3.19 mmol/l) groups. With the addition of ezetimibe or placebo to on-going simvastatin therapy, the percentage of patients achieving the LDL-C goal of ≤2.60 mmol/l after 6 weeks of treatment was significantly (p ≤ 0.001) greater in the ezetimibe group (74.3%) than in the placebo group (16.7%). The addition of ezetimibe to on-going simvastatin treatment also resulted in a significantly (p ≤ 0.001) larger mean percent reduction in LDL-C from baseline (25.2%) compared with placebo (0.9%). Ezetimibe was generally well tolerated compared to placebo when added to on-going simvastatin treatment. Conclusions: Co-administering ezetimibe with on-going simvastatin 10 or 20 mg treatment allowed more hypercholesterolemic patients with CHD to reach the LDL-C treatment target of ≤2.60 mmol/l.
- Cholesterol absorption inhibitor
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine