Efficacy and safety of ezetimibe coadministered with statins: randomised, placebo-controlled, blinded experience in 2382 patients with primary hypercholesterolemia

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Abstract
We assessed pooled safety and lipid‐regulating efficacy data from four similarly designed trials of ezetimibe coadministered with statins in 2382 patients with primary hypercholesterolemia. Patients were randomised to one of the following double‐blind treatments for 12 weeks: placebo; ezetimibe 10 mg; statin; or statin + ezetimibe. Statin doses tested were 10, 20, 40 mg/day (atorvastatin, simvastatin, pravastatin or lovastatin) or 80 mg/day (atorvastatin, simvastatin). Treatment with ezetimibe + statin led to significantly greater reductions in low‐density lipoprotein cholesterol (LDL‐C), total cholesterol, triglycerides, non‐high‐density lipoprotein cholesterol (non‐HDL‐C), apolipoprotein B and increases in HDL‐C, compared to statin alone. At each statin dose, treatment with ezetimibe + statin led to a greater LDL‐C reduction compared to the next highest statin monotherapy dose. Ezetimibe + statin had a safety profile similar to statin monotherapy. Coadministration of ezetimibe + statin offers a well‐tolerated, highly efficacious new treatment strategy for patients with hypercholesterolemia.