The results of the long-anticipated REDUCE-IT study looking at prescription-level values of omega-3 and their effect on trigylcerides have been released by Amarin Corp. and will be presented at the 2018 Scientific Sessions of the American Heart Association.
Dr. William Harris, an omega-3 expert and creator of the test that allows people to measure their omega-3 levels, called this trial a “milestone.” Recently, he said, omega-3 research has been “languishing”—patients would receive a small amount of DHA/EPA, around 850mg, and the results would be negligible. Giving the correct dosage—over four times what most patients are given in clinical trials—makes all the difference. “This is above and beyond any benefit from statins,” he said.
When asked about its effect on the dietary supplement industry, he said any effects would most likely be in terms of Amarin enforcing its patent.
REDUCE-IT was a global study to test the effects of Vascepa, a prescription product made with the omega-3 acid EPA in ethyl-ester form, on 8,179 adults with elevated cardiovascular risk controlled by statin therapy.
The patients had various cardiovascular risk factors, including persistent elevated triglycerides and either established cardiovascular disease or diabetes mellitus and a minimum of one other cardiovascular risk factor.
Half the patients were given 4 grams of Vascepa daily; the other half received a placebo. The trial took place over the course of five years.
The treatment resulted in a 25% relative risk reduction, with a high degree of statistical significance (p<.001).
Risk reduction was measured in terms of likelihood of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revasculatization, or unstable angina requiring hospitalization.
Vascepa was well tolerated, suggesting the drug is safe.
Ellen Schutt, executive director of GOED, said “GOED was pleased to see the results of the REDUCE-IT study, as it supports the body of evidence showing the benefits of omega-3s for cardiovascular outcomes. We are interested to hear more about the nuances of their research—as well as the upcoming VITAL study—when they are both presented in November at the American Heart Association Conference.”
Amarin Corp. is a pharmaceutical company focused on developing methods of improving cardiovascular health. Vascepa is their first FDA-approved drug, and they are pursuing additional regulatory approvals in Canada, China, and the Middle East.