A daily dose of a novel omega-3 carboxylic acid (EPA+DHA) compound did not reduce the risk of heart attacks, stroke, revascularization (stenting or bypass surgery), hospitalization for unstable angina, or cardiovascular (CV) death compared with a daily dose of corn oil, according to findings from the STRENGTH trial. The results stand in stark contrast to the positive results from the REDUCE-IT trial, which reported a reduction in cardiovascular events—including death—for icosapent ethyl, an EPA ethyl ester. One likely explanation can be found in the design of the two trials. The STRENGTH trial “deliberately chose corn oil as its comparator because it has a neutral effect on the clinical parameters, whereas mineral oil has a negative effect,” said the presenting author. REDUCE-IT, as well as other earlier trials that demonstrated benefits of omega-3 compounds, used mineral oil. Additionally, “REDUCE-IT enrolled more patients with established CAD.” The STRENGTH trial recruited 13,078 statintreated patients who were at high risk for CV events, with triglycerides 180-500 mg/dL, and HDL <42 mg/dL (men) or <47 mg/dL (women). Participants were randomized to 4 g of omega-3 CA or an identical corn oil placebo. The outcome for the combined efficacy endpoint was virtually the same between the groups, with a hazard ratio of 0.89. Looking at the primary prevention endpoint, the findings were also disappointing (HR, 1.16). Among patients with established CV disease, the HR was 0.94.
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