Success of Amarin trial could jumpstart further omega 3s research, expert says
William S. Harris, PhD, of the Sanford School of Medicine at the University of South Dakota, has spent his career researching the effects of these ingredients. He said the recently reported results of the REDUCE-IT trial conducted by Amarin on its Vascepa drug (which is almost pure EPA) could open up a new era of high dose trials for omega-3s.
High doses open door
“The thing that opened the eyes of a lot of people was the success of REDUCE-IT with cardiovascular disease when you finally step up to four grams a day, just of EPA in this case,” Harris said.
“We’ve done 20 years of research on one gram a day and you find it doesn’t do what you what you expected it to do. Then someone comes along with a really high dose product and gets results like these,” Harris told NutraIngredients-USA.
“It works better than any cardiovascular drug has in the past 15 years. Maybe we need to revisit trials in arthritis or vision and use higher doses,” he said.
The results of Amarin’s trial, which included more than 8,000 patients and stretched over 8 years, were formally published in January in the New England Journal of Medicine. The trial showed an approximately 25%, reduction in the risk of major adverse cardiovascular events (“MACE”) (a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization) in at risk patients after statin therapy.
In addition to his work at Sanford, Harris is also the cofounder of the Omega 3 Index, a simple blood test to verify the levels of omega 3s in red blood cells. Harris is the president and CEO of OmegaQuant, a company that markets a kit for the test.
The first work done on the health benefits of omega-3s was informed by epidemiological evidence from Greenland gathered in the 1970s. Researchers looked at the incidences of cardiovascular disease among ethnic Greenlanders living in Greenland where they ate a lot of fish versus those who had moved to Denmark. The Greenlanders living in Denmark had cardiovascular disease rates similar to those of their Danish neighbors, whereas in Greenland the malady was all but unknown.
High doses almost impossible to achieve through diet alone
Harris said when looking at the data from those earlier studies, the Greenlanders eating their traditional diet, which included lots of fish and fats from whales and seals, were probably consuming up to 7 to 8 grams of omega 3s per day. Researchers did measure omega 3 levels in plasma, but Harris’ test had not yet been invented. The Omega 3 Index expresses omega 3 levels as a percentage, with 4% being an average of the North American population and 8% or higher being a level at which these ingredients start to have more cardioprotective effects.
If in fact it proves that higher dosages are the thing to shoot for to achieve the greatest health benefit, Harris said it would make a strong case for supplementation. Current dietary recommendations call for eating fatty fish a couple of times a week, but that wouldn’t go nearly far enough, Harris said.
“Four grams a day is something that is almost impossible to do through the diet,” Harris said. The Greenlanders achieved this through a diet that would be highly impractical to replicate in another setting. Few consumers could afford to or would want to eat more than one serving of fatty fish per day, and of course no one will be gnawing on seal or whale blubber.
“We can’t assume the benefits the Greenlanders where getting were only from their omega 3 intake,” he said.
New era in research
Even if some companies may have gone overboard in touting the results of this drug trial and what it means for dietary supplements, Harris said the high dose evidence could open a new door in research in the field.
“I think before REDUCE IT the science in the field was kind of in the doldrums,” he said.
“There have been hints at lower dosages that these fatty acids could be beneficial, but now I think it’s a whole new world. What would happen if you gave 4 grams a day of just DHA alone, for example?
“I would be excited if I were a young researcher in this field. This is a very low risk intervention, and I think it is something that the NIH would go for,” he said.
The Future of Omega 3s
Harris will be a panelist on an upcoming webinar titled Omega 3s 2019 scheduled for 9:30 Central Time on July 2, 2019. Joining the panel will be Ellen Schutt, executive director of the Global Organization for EPA and DHA Omega 3s (GOED), Sam Wiley, CEO of finished goods brand Wiley’s Finest, and attorney Katie Bond of the firm Amin Talati Wasserman. The panel will look at the latest market data, delve into what recent research means for the field, as well as legal questions, including the implications of Amarin’s vigorous defense of the market for its drug Vascepa.