AstraZeneca is discontinuing a phase 3 trial evaluating Epanova (omega-3 carboxylic acids) in patients with mixed dyslipidemia who are at high risk of cardiovascular disease (CVD), as findings from the study showed the treatment was unlikely to be beneficial.
The recommendation to stop the STRENGTH trial came from an Independent Data Monitoring Committee. The large-scale study evaluated the effect of Epanova, a fish oil-derived mixture of free fatty acids, vs placebo in 13,086 patients who were on optimal statin therapy. The primary end point of the study was the time to first occurrence of any major adverse CV event (MACE), which included nonfatal myocardial infarction, nonfatal stroke, emergent/elective coronary revascularization, hospitalization for unstable angina, or cardiovascular death. Full data from the study will be presented at a future medical conference.
“The academic leadership of the STRENGTH trial is obviously disappointed in this result, but we are very proud to have had the opportunity to answer this important scientific question,” said Steven E. Nissen MD, Study Chair for the STRENGTH trial and Chief Academic Officer for the Heart and Vascular Institute, Cleveland Clinic, US.
Epanova, which is primarily composed of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), is currently approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia.
Recently, the FDA approved Vascepa (icosapent ethyl; Amarin), an ethyl ester of EPA, as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride levels (≥150mg/dL) and established CVD or diabetes mellitus and 2 or more additional risk factors for CVD.
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