FDA: Ezetimibe/simvastatin (Vytorin) effective in lowering LDL

After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.

After 2 years of treatment, patients in the ezetimibe/simvastatin group demonstrated carotid artery thickness increases of 0.011 mm compared with 0.006 mm in the simvastatin group (difference not statistically significant). Patients treated with ezetimibe/simvastatin demonstrated decreases in LDL cholesterol of 56% versus 39% among simvastatin-treated patients, a statistically significant difference.

FDA stated that these results reaffirm the agency’s position that an elevated LDL cholesterol level is a risk factor for cardiovascular disease and that lowering LDL cholesterol levels will reduce this risk. The agency said that patients should not stop taking ezetimibe/simvastatin or other cholesterol-lowering agents and should speak with their physician if they have any questions about the study results.

An ongoing trial (Improved Reduction of Outcomes: Vytorin Efficacy International Trial [IMPROVE-IT]) is assessing whether ezetimibe/simvastatin reduces the risk for cardiovascular events compared with simvastatin alone. The composite end point of this study is cardiovascular death, major coronary events, and stroke.