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REVEAL: Anacetrapib plus atorvastatin reduces coronary events in high-risk patients
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Merck announced anacetrapib, its investigational cholesteryl ester transfer protein inhibitor, significantly reduced major coronary events vs. placebo when added to statin therapy in the REVEAL trial.
The randomized, double blind, placebo-controlled clinical trial was designed to assess the efficacy and safety of adding anacetrapib to atorvastatin in approximately 30,000 patients at high risk for cardiac events despite effective LDL lowering, according to a press release from the company.
According to the release, the study met its primary endpoint of reduction of major coronary events, defined as coronary death, MI and coronary revascularization. Median follow-up was more than 4 years.
An early safety analysis of anacetrapib was consistent with results of previous studies of the drug, the company stated in the release.
Full results from the REVEAL study will be presented at the European Society of Cardiology meeting in August, and Merck is considering whether to file an application with the FDA and other regulatory agencies for an approval of the drug, according to the release.
Anacetrapib is the first CETP inhibitor to have a positive pivotal trial; trials of three others were stopped for harm or futility.