Ezetimibe/simvastatin 10/20 mg versus simvastatin 40 mg in coronary heart disease patients

BACKGROUND: Reducing low-density lipoprotein cholesterol (LDL-C) is the primary goal of therapyin patients with hypercholesterolemia and coronary heart disease (CHD).METHODS: This double blind placebo-controlled study enrolled patients 18 to 75 years of age with primaryhypercholesterolemia and establishedCHDwhowere taking a stable daily dose of simvastatin 20 mg.Patients were randomized to ezetimibe/simvastatin 10/20 mg (eze/simva; n 5 56) or simvastatin 40 mg(simva; n 5 56) for 6 weeks. Percent change from baseline in LDL-C, total cholesterol, high-density lipoproteincholesterol (HDL-C), and triglycerides were assessed by use of the Student t test. The percent ofpatients achieving LDL-C less than 100 mg/dL (,2.6mmol/L) or less than 80 mg/dL (,2.0 mmol/L) wasanalyzed via logistic regression with terms for treatment, baseline LDL-C, age, and gender.RESULTS: Baseline characteristics were similar between groups. Treatment with eze/simva combinationresulted in significantly greater reductions in LDL-C, total cholesterol, and triglycerides versusdoubling the dose of simva to 40 mg (all P , .01). Significantly more patients achieved LDL-C lessthan 100 mg/dL (,2.6mmol/L) and less than 80 mg/dL (,2.0mmol/L) with ezetimibe/simvastatin versusdoubling the dose of simva to 40 mg (73.2% vs 25.0%; P,.001) for simvastatin. Changes in HDL-C weresimilar between treatments. Both treatments were generally well tolerated.CONCLUSION: In high-risk CHD patients with hypercholesterolemia, treatment with eze/simva combinationresulted in significantly greater reductions inLDL-C, total cholesterol and triglycerides, as well asgreater achievement of recommended LDL-C targets, compared with doubling the simvastatin dose to 40mg over the 6-week period.