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

ABSTRACTObjective: 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 patients 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 on-going 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 on-going 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. Key words: : Cholesterol absorption inhibitorCo-administrationEfficacyHypercholesterolemiaStatin