-
Randomized Controlled Trial Multicenter Study Clinical Trial
LDL-C goal attainment with the addition of ezetimibe to ongoing simvastatin treatment in coronary heart disease patients with hypercholesterolemia.
- C Brohet, S Banai, A M W Alings, R Massaad, M J Davies, and C Allen.
- Saint-Luc Hospital-Catholic University of Louvain, Brussels, Belgium. brohet@card.ucl.ac.be
- Curr Med Res Opin. 2005 Apr 1; 21 (4): 571578571-8.
ObjectiveTo 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.MethodsPatients 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 10mg co-administered with on-going simvastatin 10mg or 20 mg (n = 208) versus placebo to match ezetimibe co-administered with simvastatin 10mg or 20mg for 6 weeks (n = 210).ResultsWhen 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.ConclusionsEzetimibe 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.
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