Ezetimibe coadministered with statin therapy significantly reduces LDL-C and improves goal attainment in patients with hypercholesterolemia.

Ezetimibe (EZE), coadministered with a statin, offers a dual mechanism for lowering LDL-C. In this randomized community-based clinical trial, we examined the effectiveness and safety of coadministering EZE 10 mg or placebo (pbo) with ongoing statin in 3030 patients with LDL-C levels above NCEP ATP III goals. Patients receiving marketed statins (40% atorvastatin, 29% simvastatin, 22% pravastatin, 10% other) were randomized 2:1 to EZE or pbo for 6 weeks. Efficacy endpoints included percent change from baseline in LDL-C (total population and within NCEP ATP III CHD risk category) and percent of patients reaching NCEP ATP III LDL-C goal. Study population included men (52%) and women (48%) of all races (9% black, 82% white, 5% Hispanic, 3% Asian), diabetics (38.4%) and metabolic syndrome (60%) from 299 US sites. Mean age was 62 years. Coadministration of EZE + statin significantly improved LDL-C and other measures: 71% of patients not at goal at baseline reached goal. EZE + statin was well tolerated. Results across prespecified subgroups will be presented. The coadministration of EZE with ongoing statin therapy in a large and diverse population of patients, regardless of race, risk category, age, sex or statin brand, resulted in significantly greater reductions in LDL-C and improvements in achieving ATP III goal attainment compared with adding placebo to a statin.

Thomas Pearson, MD, PhD, Margo Denke, MD, Patrick McBride, MD, MPH, Wendy P. Battisti, PhD, William E. Brady, MS, and Joanne Palmisano, MD. University of Rochester School of Medicine and Dentistry, Rochester, NY. University of Texas San Antonio Health Science Center, San Antonio, TX. University of Wisconsin Medical School, Madison, WI. Merck & Co, Inc, Rahway, NJ.