REDUCE-IT omega-3 study results show efficacy of EPA-only drug for heart disease

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Amarin Corp., maker of Vascepa, a high-concentration EPA-only omega-3 drug for heart health, published the topline results from its large-scale Reduction of Cardiovascular Events with EPA Intervention Trial (REDUCE-IT). Results showed a statistically significant relative risk reduction of 25% in the first occurrence of major adverse cardiovascular events in individuals who took the 4 g/day of Vascepa, compared to placebo.

The randomized, double-blind, placebo-controlled trial included 8,179 statin-treated adults with elevated cardiovascular risk-specifically, LDL-C levels between 41-100 mg/dL, persistent elevated triglycerides between 150-499 mg/dL, and either established cardiovascular disease or diabetes mellitus and at least one other cardiovascular risk factor. The global study began in 2011 and included subjects from 11 countries across 450 clinical sites. Treatment and placebo were administered in combination with statin.

Amarin says it plans to present the results in more detail at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018. The Global Organization for EPA and DHA Omega-3 (GOED; Salt Lake City, UT), an association representing manufacturers and marketers of EPA and DHA omega-3 fatty acids, points out that just prior to Amarin’s presentation at the AHA event, results will be presented from another significant omega-3 study, the Vitamin D and Omega-3 Trial (VITAL). VITAL is a large-scale trial study investigating whether taking an omega-3 dietary supplement can help reduce the risk of developing cancer, heart disease, and stroke.

The presentation of results from both the drug and supplement trials should be an interesting dichotomy considering that as a pharmaceutical company producing an EPA-only drug, Amarin is positioning these results and the product in contrast to omega-3 supplements. While omega-3 supplements are not made or marketed as treatments for cardiovascular disease, they are a well-established preventative measure that have gotten negative press recently, most notably from a recently published Cochrane Review (1), whose authors concluded that EPA and DHA omega-3 supplementation has “little or no effect” on mortality or heart health.

And although the REDUCE-IT trial results focus on the efficacy of a drug, not a supplement, the positive results are a good thing says Ellen Schutt, executive director of GOED. “We were pleased to see the results of the REDUCE-IT because it supports the body of evidence about the benefits of omega-3s and cardiovascular health,” she told Nutritional Outlook. “GOED looks at the nutrients EPA and DHA, rather than just one industry such as supplements, seafood, or pharma. So, to us, this is good news overall. We are interested to hear more about the nuances of their research-as well as the upcoming VITAL study.”

References:

1.Abdelhamid AS et al. “Omega-3 fatty acids for the primary and secondary prevention of cardiovascular disease.” The Cochrane Database of Systematic Reviews. Published online July 18, 2018.