Supplements industry welcomes positive results from Amarin's omega-3 study
The dietary supplement industry welcomed these positive results from the seven-year, 8,175-patient large Amarin-funded study, also known as the Reduce-It trial. Its principal investigator was Dr. Deepak L. Bhatt, MPH, a professor of medicine at Harvard Medical School.
It will be presented in November at the 2018 Scientific Sessions of American Heart Association in Chicago. (Details about the authors and other disclosures can be found HERE, though the abstract is currently embargoed.)
In a press release, Amarin stated that patients using 4 grams of Vascepa (the company’s branded EPA drug) had a 25% relative risk reduction of different endpoints, including cardiovascular death, nonfatal myocardial infaction, nonfatal stroke, coronary revascularization, and unstable angina requiring hospitalization, compared to the placebo group.
All patients were also administered statin, a lipid-lowering medication.
“Given Vascepa is affordably priced, orally administered and has a favorable safety profile, REDUCE-IT results could lead to a new paradigm in treatment to further reduce the significant cardiovascular risk that remains in millions of patients with LDL-C controlled by statin therapy, as studied in REDUCE-IT," said John F. Thero, president and CEO of Amarin.
Dietary supplement industry welcomes results
Steve Mister, president and CEO of the Council for Responsible Nutrition, a trade group representing the dietary supplement industry, told NutraIngredients-USA that the study’s positive result “is welcomed news that’s worth applauding.”
“It will be even more interesting to see how the doctors who were ready to declare a time of death for the omega 3 market will respond to this news from a gold standard trial that EPA fish oil has a benefit for cardiovascular health,” he said.
It has been a bumpy ride for fish oil’s reputation in 2018. The cardiovascular benefits of omega-3s have been under mass media scrutiny this year when results from null studies published in influential papers, JAMA Cardiology and Cochrane Review, made it into headlines such as BBC’s “Fish oil supplements for a healthy heart 'nonsense'” or Gizmodo’s “More Evidence That Fish Oil Supplements Might Be Useless.”
“[We] and others in the industry have cautioned that the previously reported studies supposedly showing no benefit were flawed,” he added. “This new study would seem to reinforce CRN’s admonitions that it’s too soon to close the door on the preventative effects of omega 3s for cardiovascular disease.”
Amarin and dietary supplements industry on same side of fence
These positive results put Amarin and the dietary supplement industry on the same side of the fence despite an ongoing complaint filed by Amarin, alleging that a wide array of dietary supplement finished goods manufacturers and suppliers are violating its patent for high concentrate ethyl esters and re-esterified triglyceride forms of omega-3 fish oils.
Related Article
Department of Justice joins chorus asking court to turn down Amarin appeal
Originally published March 28, 2018.
The complaint was first filed to the US International Trade Commission (ITC) in the August 2017, though the ITC declined the case. Amarin appealed the ITC decision and in June this year, oral arguments were heard in the US Court of Appeals for the Federal Circuit, said Ellen Schutt, executive director of the Global Organization for EPA and DHA Omega-3 (GOED).
“According to GOED’s legal counsel, Amin Talati Upadhye, the oral arguments went longer than normal at 54 minutes, indicating this is an important issue for the law in determining future jurisdiction over similar cases,” she told us.
“The overall sentiment seemed to be that FDA rather than ITC has jurisdiction over the decision on whether the defendants’ products are dietary supplements rather than prescription drugs.”
“Importantly, during the U.S. attorney argument portion, he said that FDA has not decided whether the accused omega-3 products are prescription drugs or dietary supplements, and does not plan on doing so via specific guidance in the near future,” she added.
“Our legal counsel expects that there will be a judgement in the next 2-3 months.”
CRN: Hard to tell what effects Reduce-It results will have on Amarin’s complaint
CRN’s Mister said that it’s difficult to tell whether or not the positive Reduce-It results will have any effect on Amarin’s complaint.
“We don’t know enough,” he said. “One would say, they could be even more committed to get a monopoly protection over their product because it has potentially great disease claims that they can make for it.”
He added that another argument might be, now that they have the potential for a ‘blockbuster drug’ in the prescription space, “maybe they won’t care so much if there are omega-3s in the dietary supplements world that have EPA in them.”
What’s different from the other omega-3 studies published earlier this year?
So what stood out in the Reduce-It study that garnered a positive link between omega-3s and cardiovascular benefits?
“Now they’re going to have to say ‘it’s a matter of dose,’ which has always been the case—too low of a dose doesn’t work, yeah, surprise!”
Dr. William Harris, Sanford School of Medicine at the University of South Dakota.
Dr. William Harris is a professor of medicine at the Sanford School of Medicine at the University of South Dakota in Sioux Falls, one of the world’s foremost omega-3s researchers. He is also president of OmegaQuant Analytics, LLC, a company that markets omega-3 assessments via blood test.
“The Ascend study from England and Amarin’s Reduce-It studies are the two studies to contrast,” he said, referring to the study published in JAMA Cardiology earlier this year.
Both found positive links for omega-3s and health, but the significant positive outcomes in the Ascend study were buried under other data, he argued. “Because it was piled in with other clinical endpoints, the whole composite wasn’t different, this one endpoint was different but they just didn’t highlight it.”
Despite the researchers’ conclusions in the JAMA Cardiology paper and how the media covered it after, “I think this was a successful study,” Dr. Harris said.
“I think [the Reduce-It results] will stop anybody from saying, again, that omega-3s don’t work,” he said.
“Now they’re going to have to say ‘it’s a matter of dose,’ which has always been the case—too low of a dose doesn’t work, yeah, surprise!”
"For better or worse, the public (including media) usually formulates its opinion based on the study authors’ published conclusion or a press release,"
"Clearly, the reaction to Amarin’s announcement concerning the topline results from REDUCE-IT was favorable. While I have no reason to doubt the results, which are good for both the pharma and dietary supplement space, the devil’s in the details and without such details, I would classify the reaction as irrational exuberance,"
Dr. Harry B. Rice, vice president of regulatory and scientific affairs at GOED
said Dr. Harry Rice, vice president of regulatory and scientific affairs at GOED. "The details seem to be a bother at best."
"Clearly, the reaction to Amarin’s announcement concerning the topline results from REDUCE-IT was favorable. While I have no reason to doubt the results, which are good for both the pharma and dietary supplement space, the devil’s in the details and without such details, I would classify the reaction as irrational exuberance," he added.
"Likewise, I would classify the reaction to last month’s publication of results from A Study of Cardiovascular Events in Diabetes (ASCEND) as short-sighted, particularly given that the details were available for scrutiny. While the authors concluded no benefit of omega-3s, the omega-3 group had an 18% statistically significant reduction in risk of vascular death, which was defined in the study design as being part of the primary outcome of serious vascular events. So, not only did the results demonstrate a statistically significant and clinically relevant benefit, but these are the first significant results to be reported for primary prevention."
Study should be read in context
Mister added that the Reduce-It study should be read in context. “The group showing a greatest reduction of heart attack risk in the REDUCE IT trial is apparently a group of carefully selected patients already treated with statins to lower their LDL cholesterol, who had particular cardiovascular risk factors, including persistent elevated triglycerides.”
“We know that omega-3s reduce triglycerides. But we also know that marketers have to closely examine and understand the studies they use to support their marketing claims,” he added.
“Studies performed in a narrowly defined diseased population using high dosages of a specific ingredient may not translate to usable structure/function claims in the dietary supplement arena. We will be eager to learn more about the details of the REDUCE IT when it is released in November and what these results may mean for omega 3s more generally.”
