Eli Lilly announced Thursday that it accepted a recommendation by the ACCELERATE study academic executive committee to extend the late-stage study of the investigational CETP inhibitor for the treatment of high-risk atherosclerotic cardiovascular disease (ASCVD) by about six months. The company said that as such, a futility analysis previously anticipated in the first quarter of the year, is now expected to occur in the third quarter of 2015.
The drugmaker noted that the recommendation was not based on study results, as both academic committee and the company remain blinded to efficacy data, but on what it called "emerging science in the cardiovascular field." Eli Lilly explained that the committee based its recommendation on an analysis of the results of other studies of therapies designed to reduce major adverse cardiovascular events (MACE).
In November last year, Merck & Co. announced that the IMPROVE-IT study of Vytorin, which combines Zetia (ezetimibe) with the statin simvastatin, met its primary endpoint, demonstrating a 6.4-percent reduction in cardiovascular events in patients with high cholesterol. At the time, study author Christopher Cannon remarked "this is the first time that something added to statins has been shown to be beneficial." For related analysis, see ViewPoints: IMPROVE-IT may remove regulatory risk for PCSK9 agents, while raising commercial questions.
Eli Lilly and the academic committee indicated Thursday that the longer treatment duration in the ACCELERATE study will permit appropriate testing of the hypothesis that the addition of evacetrapib to statins can reduce MACE compared to statins alone in patients with high-risk ASCVD. The trial's main goal is time to first occurrence of any component of the composite cardiovascular events of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or hospitalization for unstable angina. The drugmaker noted that the last patient visit in the study, which includes 12 095 patients, is not expected to occur in July 2016.
Meanwhile, Merck is also developing the CETP inhibitor anacetrapib.
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