02 Apr ACC2020: REDUCE-IT Trial of a Unique Prescription Fish Oil to Prevent Cardiovascular Events
MedicalResearch.com Interview with:
Nathan D. Wong, PhD, FACC, FAHA, FNLA
Professor and Director
Heart Disease Prevention Program
Division of Cardiology, University of California, Irvine
MedicalResearch.com: What is the background for this study?
Response: Many higher risk persons, despite guideline-recommended therapy such as statins, still suffer from cardiovascular disease events. There are few therapies available to reduce this persistent risk. The REDUCE-IT trial led by Brigham and Women’s Hospital in Boston researchers originally published in November of 2018 was landmark in showing for the first time a highly purified, stable, prescription fish oil product, icosapent ethyl (an EPA only compound marketed as Vascepa®) if given to high risk persons with either cardiovascular disease or diabetes and two or more risk factors who were on statin therapy and had elevated triglyceride levels, achieved an unprecedented 25 percent reduction in the risk of time to first cardiovascular disease events. Given that many persons often experience multiple cardiovascular events, a follow-up analysis showed that TOTAL cardiovascular events were reduced by 30 percent.
MedicalResearch.com: What are the main findings?
Response: Not established is how many cardiovascular events (including heart attacks and strokes) could be prevented if all US adults similar to those in the REDUCE-IT trial took this therapy. Our project at UCI involved a statistical analysis applying the REDUCE-IT treatment and placebo cardiovascular event rates to US adults in the National Health and Nutrition Examination Survey who fit REDUCE-IT eligibility criteria. Such persons had to have either cardiovascular disease or diabetes and two other risk factors, triglyceride levels of 135-499 mg/dL, as well as be on a statin and have well-controlled LDL-cholesterol levels of between 40 and 100 mg/dL.
We estimated that on an annual basis, 71,391 total cardiovascular events could be prevented if such eligible US adults were given this therapy. This included 29,798 first events and 41,593 repeat events.
MedicalResearch.com: What should readers take away from your report?
Response: It is important for people to be aware, especially if they have a history of heart attack, stroke, or other cardiovascular disease, or diabetes, along with elevated triglyceride levels that despite statins and other evidence-based therapies, that the likelihood of suffering future cardiovascular events remains significant. Icosapent ethyl is the only FDA-approved highly purified, stable, prescription product shown to significantly reduce this “persistent risk” in such persons.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: It will be important to further examine the impact of this therapy in other real-world patient populations and the extent to which the findings may apply to lower risk populations. Moreover, we need to better understand what possible mechanisms, such as potential antioxidant and anti-inflammatory mechanisms, are most responsible for the beneficial effects of this therapy. A late-breaking scientific presentation scheduled to be presented at the American College of Cardiology meeting suggests that it may be the blood levels of EPA achieved from icosapent ethyl that is associated with most of the cardiovascular benefits.
MedicalResearch.com: Is there anything else you would like to add?
Response: It is important patients understand that the beneficial effects of this highly purified, stable, prescription EPA product cannot be extrapolated to other fish oil products which have not been shown in clinical trials to reduce cardiovascular risk. Moreover, dietary fish oil products often contain significant impurities such as saturated fat and are not FDA-approved.
Disclosures: This research was supported by a contract from Amarin Pharma to the University of California, Irvine.
REDUCE-IT eligibility and preventable first and total cardiovascular events in the US population: an analysis of the national health and nutrition examination survey (NHANES)
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Last Updated on April 2, 2020 by Marie Benz MD FAAD