Therapy with icosapent ethyl, a purified stable eicosapentaenoic acid (EPA), could help prevent more than 70,000 cardiovascular events per year in US adults with a history of cardiovascular disease (CVD) or diabetes mellitus. This is the conclusion of a multinational clinical trial called REDUCE-IT conducted at the University of California, Irvine (UCI), US, that will be presented at the upcoming ACC.20/World Congress of Cardiology conference. As heart health remains a constant national concern, this study provides a promising avenue for further research on long-term preventive measures to cardiovascular events via supplementation.

“I was not surprised by the findings given the unprecedented results showed an overall 25 percent reduction in CVD event risk. These results apply to many patients with CVD or diabetes who are on statin therapy,” lead study author Dr. Nathan Wong, Professor and Director, Heart Disease Prevention Program and Division of Cardiology at the UCI tells.

The study identified 319 US adults with prior CVD and diabetes mellitus with available REDUCE-IT inclusion criteria from the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) surveys 1999-2016. The researchers estimated that if the test subjects are given icosapent ethyl for the REDUCE-IT median trial period of 4.9 years, it could potentially prevent a total of 349,817 primary CVD outcomes, or 71,391 per year. Common primary CVD events include CVD death, nonfatal myocardial infarction, stroke, revascularization or unstable angina.

Metrics of the REDUCE-IT study.Market positioning
The heart health benefits associated with omega 3 supplements have the nutrition industry booming. Over the past four years, global supplement launches featuring omega 3 (EPA, docosahexaenoic acid (DHA) or fish oil) as an ingredient have witnessed an average annual growth of 8.7 percent between 2016 and 2019, according to Innova Market Insights.

Moreover, the market researcher further notes omega 3 inclusion has the highest penetration in Asia, with nearly 8 percent of all supplement launches tracked feature omega 3 as an ingredient (Asia, 2019). Omega 3 also ranked second in Top 5 positionings for supplement launches tracked with marine oils alone (Global, 2019).

However, Dr. Wong stresses that icosapent ethyl is not meant for broader supplement usage. “The purity and processing of the icosapent ethyl product is very different from nutritional supplement omega 3 products. The findings of REDUCE-IT must not and should not be extrapolated to any other fish oil product. Vascepa is also the only fish oil product that is US Food and Drug Administration (FDA)-approved to reduce the risk of cardiovascular events. No other prescription or dietary supplementary fish oil product can make that claim,” Dr. Wong underscores.

Vascepa produced by Amarin Pharma was used as the basis of the REDUCE-IT analysis. Besides lowering cardiovascular events, icosapent ethyl is FDA-approved to reduce very high triglycerides. It can also reduce cardiovascular events in patients with multiple CVD risk factors who have moderately elevated triglycerides and are on maximally tolerated statin therapy.

What’s next?
As the most used omega 3 fatty acids, both EPA and DHA are touted for their heart health benefits. However, DHA was not used in the REDUCE-IT trial. “There is much we still need to understand about the differences between EPA and DHA,” explains Dr. Wong. “There is data suggesting differences in the ability to stabilize cell membranes that could affect lipid transport. In addition, DHA is known to raise LDL-cholesterol.”

“We hope that similar analyses can be done in other real-world populations, ideally those with follow-up for actual cardiovascular events and mortality that will help to further validate the impact of this therapy in different patient populations,” Dr. Wong concludes.