REDUCE-IT Cardiovascular Outcomes Trial Reveals Significant Reduction in Major Cardiovascular Events

Last Updated: Saturday, 10-Nov-2018 23:00:00 EST

Nov. 10, 2018

CHICAGO The REDUCE-IT cardiovascular outcomes trial results, announced today at the American Heart Association Scientific Sessions in Chicago, met its primary composite endpoint and revealed a reduction in major adverse cardiovascular events (MACE) of 25%.

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According to the REDUCE-IT results, 8,179 patients were randomized on statin plus VASCEPA 4g/day or statin plus placebo over a median 4.9 years. The LDL of range for enrolled patients was between 41-100 mg/dL (median baseline of 75 mg/dL) with various cardiovascular risk factors including elevated triglycerides between 150-499 md/dL (median baseline of 216 mg/dL) and either established cardiovascular disease (secondary prevention) or diabetes mellitus and at least one other CV risk factor (primary prevention). In addition to the reduction in MACE, the data showed a median reduction in triglyceride level of 18.3% (-39 mg/dL) versus an increase of 2.2% in the placebo group from baseline to one year.

According to the trial results, VASCEPA was well tolerated by the enrolled patients with a safety profile consistent with omega-3 fatty acids and current FDA-approved labeling.

“The NLA is excited to about the impact of another beneficial therapy in the clinician’s toolbox to safely treat cardiovascular disease and proud of its many members of the NLA participated in the trial as leaders and investigators,” said Alan S. Brown, MD, FNLA, National Lipid Association president.

The NLA 2019 Spring Clinical Update, scheduled for Feb. 22-24, 2019 in Portland, Ore., will feature Michael Miller, MD, and Peter Jones, MD, FNLA, discussing the REDUCE-IT results and the implications of REDUCE-IT on other trials in progress.

VASCEPA (icosapent ethyl), commercialized by Amarin Corporation, is the first eicosapentaenoic acid (EPA) treatment approved by the United States Food & Drug Administration (FDA) to lower triglycerides.

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