When added to a statin, the cholesterol absorption inhibitor ezetimibe (Zetia) results in additional lowering of blood cholesterol. In this community-based, manufacturer-sponsored, randomized trial, researchers assessed the cholesterol-lowering effect of ezetimibe as add-on therapy. Three of the six authors were employed by the manufacturer.
The trial included 3030 patients who had been taking statins (mostly atorvastatin, pravastatin, and simvastatin, at doses of 10–40 mg daily) for at least 6 weeks but who had not achieved LDL cholesterol target levels recommended by the National Cholesterol Education Program (NCEP). Patients received ezetimibe (10 mg daily) or placebo for 6 weeks, while they continued their current statin brands and doses.
Overall, mean LDL cholesterol levels (129 mg/dL on statin monotherapy) decreased by 26% in the ezetimibe group and by 3% in the placebo group — a significant difference. LDL cholesterol was lowered to a similar extent among patients in all NCEP risk categories, among patients who took each of the three statin brands, and at all statin doses. The target LDL was reached by 71% of ezetimibe recipients and by 21% of placebo recipients. No serious adverse events were reported.
Ezetimibe lowers LDL cholesterol levels to a similar extent when it is added to statin therapy, at any statin dose. A limitation of this study was its short 6-week duration. Moreover, some patients might have achieved sufficient additional cholesterol lowering by increasing statin doses rather than by adding ezetimibe to low-dose statin. Finally, no ezetimibe trials with clinical endpoints have been completed.
References:
1. Pearson TA et al. A community-based, randomized trial of ezetimibe added to statin therapy to attain NCEP ATP III goals for LDL cholesterol in hypercholesterolemic patients: The Ezetimibe Add-On to Statin for Effectiveness (EASE) trial. Mayo Clin Proc 2005 May; 80:587-95.
2. Hurley DL and Isley WL. Getting there: Statin plus ezetimibe for low-density lipoprotein cholesterol goals. Mayo Clin Proc 2005 May; 80:585-6.