LDL-C goal attainment with the addition of ezetimibe to on-going simvastatin treatment in coronary heart disease patients with hypercholesterolemia

Objective: To evaluate the addition of ezetimibe or placebo to on-going simvastatin treatment on attaining the LDL-C treatment target of <= 2.60 mmol/L (100 mg/dL) in coronary heart disease (CHD) patients with hypercholesterolemia. Methods: Patients with documented CHD were recruited if they were on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks, had LDL-C > 2.60 mmol/L and: <= 4.20 mmol/L (> 100 mg/dL and <= 160 mg/dL), triglycerides <= 4.00 mmol/L (355 mg/dL) and hepatic transaminases and creatine kinase: 50% above the upper limit of normal. After a 4-week placebo and diet run-in period, eligible patents were randomized to a double-blind, placebo-controlled comparative study with ezetimibe 10 mg co-administered with on-going simvastatin 10 mg or 20 mg (n = 208) versus placebo to match ezetimibe co-administered with simvastatin 10 mg or 20 mg for 6 weeks (n = 210). Results: When ezetimibe was added to on-going simvastatin therapy, a significantly greater percentage of patients attained the LDL-C target of <= 2.60 mmol/L after 6 weeks of treatment compared to placebo added to ongoing simvastatin (80.4% vs. 17.4%, respectively; p! 0.001). When co-administered with on-going simvastatin therapy, mean percentage reduction in LDL-C from baseline was significantly larger in the ezetimibe group compared to placebo (27.1% vs. 4.1%, respectively; p <= 0.001). The co-administration of ezetimibe or placebo to ongoing simvastatin treatment was generally well tolerated. Conclusions: Ezetimibe co-administered with on-going simvastatin 10 mg or 20 mg treatment enabled more CHD patients with hypercholesterolemia to attain the LDL-C treatment target of <= 2.60 mmol/L.