Two leading cardiologists are divided Sunday during the 70th American College of Cardiology (ACC) Scientific Session on how to interpret contrasting and provocative results from trials involving various formulations of omega-3 fatty acids. In November 2018, Harvard’s Deepak L. Bhatt, MD, MPH, amazed the cardiology community with outcomes that showed a refined form of icosapent ethyl (EPA) had decreased cardiac issues or death by 25%. The fish oil capsules, that had been sold for many years as Vascepa to treat high triglycerides, then got an FDA indication as an add-on to statins to inhibit cardiovascular events. Initial quarter revenues for 2021 for Amarin, based on Vascepa sales, were 141.4 million dollars.
A new posthoc analysis of the STRENGTH trial suggests that omega-3 fatty acids from prescription fish oil may not affect cardiovascular event reduction. Thus, a group of investigators, led by Steven Nissen, MD, MACC, Cleveland Clinic, tried to reconcile the opposing evidence between the studies. Initially, they assessed a subset of the 13,078 individuals from the STRENGTH trial (n = 10,382). Of this subgroup, 5175 had taken omega-3 carboxylic acid, and 5,207 received corn oil. The average age of this population was 62.5 years, a majority (2/3) were men, and a third of cases had diabetes. They found that cardiovascular events such as heart attack, cardiovascular death, stroke, need for procedures to open blocked arteries, or chest pain that required hospitalization happened in 11.1% and 11% of omega-3 and placebo patients.
“In the past, we have gone out to one year on studies, but now our thinking is that most of that risk in the initial 3 months,” Gibson stated. “So from now on, we are beginning to move trials to a 30-90 day endpoint, where we got events we can find, and where the statistical power is greatest as we have higher event rates and we’ve therapies that can hopefully lessen them.”