placebo + simvastatin

Placebo + simvastatin refers to the control arm of the Phase 3 ENHANCE (Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression) trial. In this study, patients with heterozygous familial hypercholesterolemia (HeFH) were randomized to receive either a combination of ezetimibe and simvastatin or simvastatin monotherapy. The control arm consisted of 80 mg of simvastatin daily plus a matching placebo to maintain the double-blind design. Simvastatin is a well-established small molecule HMG-CoA reductase inhibitor (statin) that lowers LDL cholesterol by competitively inhibiting the enzyme 3-hydroxy-3-methylglutaryl coenzyme A reductase, which is the rate-limiting step in hepatic cholesterol biosynthesis. This inhibition leads to an upregulation of LDL receptors on the surface of hepatocytes, increasing the clearance of LDL from the blood. The trial was sponsored by Organon & Co. (with support from Merck and Schering-Plough) and evaluated the change in carotid artery intima-media thickness (CA IMT) over 24 months.

Other names

simvastatin plus placebosimvastatin monotherapysimvastatin alone