Merck's CETP inhibitor may miss the mark for CV benefit

Merck & Co. Inc. (NYSE:MRK) reported additional data from the Phase III REVEAL cardiovascular outcomes trial showing that anacetrapib (MK-0859) reduced major coronary events -- the primary endpoint defined as a composite of coronary death, myocardial infarction or coronary revascularization -- by 9% compared to placebo (1,640 vs. 1,803 events, p=0.004). That 9% relative risk reduction may not be enough to convince doctors to use anacetrapib in the second-line setting for hyperlipidemia over generic ezetimibe.

First announced in June, the REVEAL data are the first to show a CV outcomes benefit for a cholesteryl ester transfer protein (CETP) inhibitor. However, in the initial top-line report Merck said anacetrapib met the primary endpoint but did not disclose specific data, leaving the lingering question of whether the relative risk reduction is large enough for an approval, and would doctors to be willing to use anacetrapib over generic ezetimibe. At the time, three cardiologists told BioCentury that anacetrapib would have to show at least a 10% relative risk reduction for them to consider the benefit clinically meaningful (see BioCentury, July 7)...