Merck Inc. announces positive outcomes of REVEAL study of anacetrapib (MK 0859) showing a reduction of coronary events.

Merck Inc. , known as MSD outside of the United States and Canada, announced that the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events (defined as the composite of coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen. The safety profile of anacetrapib in the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue, as has been previously reported.

Merck plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the FDA and other regulatory agencies. The results of the REVEAL study will be presented at the European Society of Cardiology meeting on 29 August 2017. Anacetrapib is Merck�s investigational cholesteryl ester transfer protein (CETP) inhibitor.

The REVEAL study is a randomized, double-blind placebo-controlled clinical trial to assess the efficacy and safety of adding anacetrapib to effective LDL-lowering treatment with atorvastatin for a median duration of at least 4 years among approximately 30,000 patients at high risk of cardiovascular events. REVEAL was designed and independently conducted by investigators at the Clinical Trial Service Unit (CTSU) at the University of Oxford, the trial�s regulatory sponsor, in collaboration with the TIMI Study Group based at Brigham and Women�s Hospital in Boston and Merck. Merck provided funding for REVEAL. Details on the REVEAL study design are available at clinicaltrials.gov: https://clinicaltrials.gov/show/NCT01252953.

Comment: The outcomes are a surprise after earlier mixed results with a class of drugs, cholesteryl ester transfer protein (CETP) inhibitors, that have posted negative results at Pfizer, Roche and Eli Lilly due to safety issues.