Deepak L. Bhatt, MD, MPH: My hope is that the trial results of REDUCE-IT will be viewed as practice changing. Certainly we saw large degrees of benefit across a variety of different endpoints, including a 20% risk reduction in cardiovascular death that was statistically significant. We also saw significant reductions in myocardial infarction, stroke, hospitalization for unstable angina, revascularization procedures. The number of events that were preventable, in terms of the population treated, was really quite substantial. Therefore, I think physicians will view the results as practice changing once they become familiar with the trial results.
Whether the results apply to icosapent ethyl, the prescription medication that we studied, or whether they would be generalized to other triglyceride-lowering compounds or omega-3 fatty acids is a question that I’m commonly asked. I think the results of the trial apply to the drug we studied, which was icosapent ethyl, 2 g twice a day. So a total of 4 g per day of that highly purified eicosapentaenoic acid [EPA]. That’s very different from studies such as the ASCEND trial or the VITAL trial, which also examined omega-3s at a lower dosage—1 g a day—and mixed preparations of DHA [docosahexaenoic acid] and EPA, not a pure EPA at a high dosage as we studied. I don’t think the results of our trial could be applied to those drugs, which in fact have been shown to be negative in terms of trials such as VITAL and ASCEND and meta analyses of some of the older trials.
The results that we saw, which I think are quite impressive in terms of magnitude of benefit, really shouldn’t be extrapolated to other compounds—either other prescription compounds that may lower triglycerides, such as the ones I mentioned, or fibrates or niacin—and certainly shouldn’t be extrapolated to over-the-counter supplements, which are not closely regulated and have variable degrees of EPA, DHA ,and other substances, and saturated fats, and so on. Really, the results should be applied to icosapent ethyl. In the most recent update to the guidelines by the American Diabetes Association [ADA], they agreed. They gave a Level A recommendation, their highest level of evidence—2 years of icosapent ethyl in primary and secondary prevention-type patients with elevated triglycerides in the range of 135 to 500 [mg/dL] despite therapy with statins.
That’s really the target population for icosapent ethyl, and those ADA 2019 updated guidelines say that the results really shouldn’t be applied to supplements, niacin, or fibrates. In fact, they say those different compounds shouldn’t be used with statin therapy, because there’s no evidence supporting their use.
Transcript edited for clarity.