MSD has revealed that its CETP inhibitor anacetrapib reduced the risk of major coronary events by 9 percent versus placebo in patients with cardiovascular disease already taking LDL-C lowering therapy alongside atorvastatin.
Data from the 30,000 patient REVEAL trial, published in the New England Journal of Medicine and presented at the European Society of Cardiology congress in Barcelona, show a significantly lower incidence of the composite endpoint of coronary death, myocardial infarction, and coronary revascularisation compared to placebo in patients at risk for cardiac events.
Compared with placebo, the addition of anacetrapib further reduced the mean level of non-HDL cholesterol by 18 percent and increased HDL cholesterol level by 104 percent at the study midpoint.
The difference in the key secondary composite outcome of major atherosclerotic events (myocardial infarction, coronary death or presumed ischaemic stroke) did not reach statistical significance, but according to the firm this was possibly due to a lack of observed benefit of the drug on presumed ischaemic stroke.
“Despite treatment advances in recent years, patients with cardiovascular disease remain at risk of major coronary events. We are pleased with these findings which show that adding anacetrapib to statin therapy resulted in a further reduction of coronary events in REVEAL,” said Louise Houson, UK managing director, MSD, commenting on the data.
Jules Payne, chief executive of charity HEART UK, highlighted the increase in HDL as interesting and also the fact that the drug was shown to be “well tolerated”, and noted that the 9 percent proportionate reduction in adverse events “could increase with patients being treated for longer.”
MSD says it is reviewing the results of the study with external experts and will consider whether to file new drug applications with the US Food and Drug Administration and European Medicines Agency.
However, according to Reuters, Bernstein analyst Tim Anderson believes it unlikely that the firm will go ahead with filing anacetrapib for approval, while Berenberg’s Alistair Campbell described the results as lacklustre.
Anacetrapib works by inhibiting a protein called cholesterol ester transfer protein (CETP), which is designed to lift HDL - or good - cholesterol. However, the class of drugs has been hit with a series of high-profile failures because of safety issues and mediocre efficacy.