LDL-C Goal Attainment With Ezetimibe Plus Simvastatin Coadministration vs Atorvastatin or Simvastatin Monotherapy in Patients at High Risk of CHD

James McKenney, PharmD; Christie M. Ballantyne, MD; Theodore A. Feldman, MD; William E. Brady, MS; Arvind Shah, PhD; Michael J. Davies, PhD; Joanne Palmisano, MD; Yale B. Mitchel, MD

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Abstract and Introduction

Aims: To compare the proportion of patients at high risk for coronary heart disease (CHD) achieving the recommended low-density lipoprotein cholesterol (LDL-C) treatment goal of < 100 mg/dL and the optional LDL-C target of < 70 mg/dL with coadministration of ezetimibe and simvastatin (EZE/SIMVA) vs either atorvastatin or simvastatin monotherapy.
Patients: Patients with established CHD or CHD risk equivalent according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria with baseline LDL-C ≥ 130 mg/dL and triglycerides (TG) ≤ 350 mg/dL.
Methods: A post hoc analysis from 2 separate studies assessed the percentage of high-risk patients achieving the LDL-C targets (< 100 and < 70 mg/dL) after 6 weeks on the usual recommended starting doses of the following treatments: EZE/SIMVA (10/20 mg) vs atorvastatin (10 mg) or simvastatin (20 mg). Depending on the study, EZE/SIMVA 10/10 or 10/40 mg was also compared with either atorvastatin 10 mg or simvastatin 20 mg. Percent change in other lipid parameters from baseline to study endpoint was also examined.
Results: In both studies, the proportions of patients achieving an LDL-C of < 100 mg/dL were significantly (P < .001) greater for EZE/SIMVA 10/10, 10/20, or 10/40 mg vs either atorvastatin 10 mg or simvastatin 20 mg after 6 weeks. The percentage reaching the optional LDL-C treatment target of < 70 mg/dL was also significantly higher with EZE/SIMVA compared with either atorvastatin or simvastatin. Percent reduction in LDL-C was significantly (P < .001) larger with all doses of EZE/SIMVA (46% to 59%) compared with either atorvastatin 10 mg (37%) or simvastatin 20 mg (38%) monotherapy after 6 weeks. Changes in other lipid parameters consistently favored EZE/SIMVA vs statin monotherapy. All treatments were well tolerated in both studies.
Conclusion: Patients at high risk for CHD are more likely to attain LDL-C treatment targets with the usual recommended starting dose of EZE/SIMVA (10 or 20 mg) therapy than with that of atorvastatin (10 mg) or simvastatin (20 mg) monotherapy.

Despite the wealth of clinical trial data and treatment guidelines describing the clinical benefits of lipid-lowering treatments, many patients at high risk for CHD do not reach low-density lipoprotein cholesterol (LDL-C) treatment goal (<100 mg/dL) on lipid-lowering therapies.[1,2] Selection of therapies, inadequate efficacy of starting doses of lipid-lowering therapies, poor patient compliance, and patient/physician reluctance to titrate to higher doses of statins or other lipid-lowering drugs because of safety concerns are among the explanations for the shortfall in LDL-C goal attainment.[3,4,5,6] Furthermore, the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) recently recommended a lower and more aggressive LDL-C target of less than 70 mg/dL as a therapeutic option for patients at very high risk.[7] Thus, more effective lipid-lowering therapies are needed to reach the established LDL-C goal (< 100 mg/dL) and the new, optional LDL-C treatment target (< 70 mg/dL).

The combination tablet containing ezetimibe and simvastatin (EZE/SIMVA) is a cholesterol-lowering agent that affects cholesterol metabolism through two different mechanisms of action: inhibition of cholesterol absorption in the intestine and inhibition of cholesterol synthesis in the liver. Coadministration of EZE/SIMVA has been demonstrated to be more effective in lowering LDL-C and increasing the proportion of patients achieving NCEP-ATP III LDL-C treatment targets than comparable or higher doses of atorvastatin or simvastatin monotherapy.[8,9,10,11,12]

Therefore, the purpose of this analysis was to compare the proportion of patients at high risk for CHD achieving LDL-C targets on the usual recommended starting dose of the dual therapy of EZE/SIMVA vs that of atorvastatin or simvastatin monotherapy.

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