By William S. Harris, Ph.D.
As a retailer, omega-3 fatty acids (EPA and DHA) probably represent a large part of your business. If that’s the case, then you should be highly interested in two new studies — Reduce-IT and VITAL — that were presented at the American Heart Association Meeting this past Saturday, Nov. 10.
Both were also published in the Nov. 10 online edition of the New England Journal of Medicine. And both are receiving very high profile media attention, which means your customers are likely to have questions about the omega-3s they purchase as a result.
Reduce-IT is the highest-dose study with omega-3s ever performed, and VITAL is the largest, making these two critical studies in the evolving omega-3 story. From a very high level, the former evaluated a high dose of EPA only (4 g/day) in statin-treated adults (with mildly elevated blood triglyceride levels) to see if it would work better than statins alone in preventing issues related to cardiovascular disease. The latter evaluated whether or not omega-3s and vitamin D could prevent cancer, heart disease or stroke in otherwise healthy people.
REDUCE-IT, which stands for Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial, followed more than 8,000 people, all of whom were at elevated risk for heart disease and were taking statins. Half were assigned to take 4 g/day of Vascepa, a fish oil-based drug from Amarin, and the other half got placebo. They were followed for about five years.
Taking Vascepa in conjunction with statins lowered the chances of having a cardiovascular event by 25%, while the risk of death went down 20%.
The lead author in the study — Dr. Deepak L. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston — said he thinks this is the biggest development in cardiovascular prevention since statins were introduced. And he hopes that these results will be practice-changing for doctors who deal with heart patients.
The VITAL study, which stands for VITamin D and OmegA-3 TriaL (VITAL), followed more than 25,000 people over a period of five years to see if 1 gram of fish oil (providing 840 mg EPA+DHA; Lovaza, GSK) or 2000 IU of vitamin D could prevent cardiovascular disease, cancer or stroke. Lovaza was the first FDA-approved fish oil-based drug. It differs from Vascepa in that it contains DHA as well as EPA.
People in the omega-3 arm of VITAL experienced significantly reduced risk for having a myocardial infarction (MI; 28% lower) and for dying from an MI (50% lower). On the other hand, there was no effect on risk for stroke.
Together, these studies highlight the fact that dose matters. The more omega-3s EPA and DHA you get, the lower your chances are for experiencing a cardiovascular event. One way to achieve this is by focusing on taking enough EPA and DHA to get to an Omega-3 Index of >8%.
Strictly speaking, the REDUCE-IT findings only apply to heart disease patients and to the use of 4 grams of EPA, but in my opinion, the overall tale they tell is that higher amounts of omega-3s produce better outcomes.
Bottom line: Both Vascepa and Lovaza are FDA-approved drugs, even though they are derived from fish oil. If your customers ask about these studies, it would be wise to make sure they understand this. HOWEVER, since the Lovaza dose is very similar to a dietary supplement dose, and since it has both EPA+DHA like most supplements, and since many supplements provide omega-3s EPA and DHA in ethyl ester form (as they are in Lovaza), extrapolating the findings from VITAL’s omega-3 arm to dietary supplements will be much more easily done than it is from REDUCE-IT.
About the author: William S. Harris, PhD, is the president of OmegaQuant, a fatty acid testing lab. He has been researching omega-3s EPA and DHA for the last 35 years. To date Dr. Harris has published more than 300 papers on fatty acids. He also created the Omega-3 Index test, which measures the amount of omega-3s EPA and DHA in the blood. He is also the author on two American Heart Association scientific statements on fatty acids: “Fish Consumption, Fish Oil, Omega-3 Fatty Acids and Cardiovascular Disease” (2002), and “Omega-6 Fatty Acids and Risk for Cardiovascular Disease” (2009) both published in the journal Circulation. He can be reached at firstname.lastname@example.org