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 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.
Employers Face Barriers With Adopting Biosimilars
March 1st 2022Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.