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

Author(s): Davidson MH, Ballantyne CM, Kerzner B, Melani L, Sager PT, Lipka L, Strony J, Suresh R, Veltri E, Ezetimibe Study Group

Affiliation(s): Radiant Research, Chicago, IL 60610-4324, USA. michaeldavidson@radiantresearch.com

Publication date & source: 2004-08, Int J Clin Pract., 58(8):746-55.

Publication type: Clinical Trial; Clinical Trial, Phase I; Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial

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.