The Randomized Evaluation of the Effects of Anacetrapib Through Lipid Modification (REVEAL) outcomes study of anacetrapib (Merck) has met its primary endpoint, significantly reducing major coronary events (defined as the composite of coronary death, myocardial infarction, and coronary revascularization) compared with placebo in patients at risk for cardiac events who are already receiving an effective low-density lipoprotein-cholesterol (LDL-C)–lowering regimen.
Anacetrapib is an investigational cholesteryl ester transfer protein (CETP) inhibitor. CETP inhibitors block a protein that transfers high-density lipoprotein-cholesterol (HDL-C) to LDL-C, resulting in higher levels of HDL and lower LDL levels. Statins, by contrast, work by reducing the liver’s production of cholesterol.
During the past decade, three experimental CETP inhibitors from Pfizer, Roche, and Eli Lilly have failed in tests, according to Reuters.
The REVEAL trial was a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of adding anacetrapib to effective LDL-lowering treatment with atorvastatin for a median period of at least four years in approximately 30,000 patients at high risk of cardiovascular events.
Merck plans to review the results of the study with external experts and will consider whether to file a new drug application with the FDA.