IngentaConnect LDL-C goal attainment with the addition of ezetimibe to ongoing s...

Abstract:

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 10mg or 20mg for at least 6 weeks, had LDL-C > 2.60mmol/L and ≤ 4.20mmol/L (> 100mg/dL and ≤ 160mg/dL), triglycerides ≤ 4.00mmol/L (355mg/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 10mg co-administered with on-going simvastatin 10mg or 20mg (n = 208) versus placebo to match ezetimibe co-administered with simvastatin 10mg or 20mg 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.

Keywords: CHOLESTEROL ABSORPTION INHIBITOR; CO-ADMINISTRATION; EFFICACY; HYPERCHOLESTEROLEMIA; STATIN

Document Type: Research article

DOI: 10.1185/030079905X382004

Affiliations: 1: Saint-Luc Hospital-Catholic University of Louvain, Brussels, Belgium

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