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ACC: Improved Outcomes With Icosapent Ethyl in Updated REDUCE-IT Data

Benjamin Morgan Scirica MD

https://www.practiceupdate.com/c/98655/1/2/?elsca1=emc_enews_expert-insight&elsca2=email&elsca3=practiceupdate_cardio&elsca4=cardiology&elsca5=newsletter&rid=MjYwNjcyNjIxNDc3S0&lid=10332481

Dr. Scirica: Hi. This is Ben Scirica. I'm a cardiologist at Brigham and Women's Hospital and Harvard Medical School, and I'm here with PracticeUpdate to talk about some of the recent studies that came from the ACC 2020 virtual conference.

Could you provide an overview of the design and results of the REDUCE-IT trial?

Dr. Scirica: So, the REDUCE-IT trial was a study that looked at over 8000 statin-treated patients who had mildly elevated triglycerides and LDLs that were in a current level between 40 and 100 and a history of atherosclerotic disease and diabetes, and they were randomized either to icosapent ethyl 4 g/day or placebo. And this is a very highly refined pharmaceutical brand of EPA.

How does this subgroup analysis add to the previously published data from the trial?

Dr. Scirica: So, the overall trial showed that icosapent ethyl reduced the risk of cardiovascular events, cardiovascular death, non-fatal MI and stroke, and coronary revascularization in the overall cohort. This study presented at ACC and published simultaneously looked at the 3146 patients from the United States, who were about a third of the patient population, and looked at their outcomes, and there was very consistent results within the United States' cohort such that the key primary endpoint as well as the key secondary endpoints all had reductions that were as good or even a little bit better than the overall trial population.

This is important for a couple reasons. First, there is always concern that in the United States that there may be treatment differences compared to other countries, and if a trial has a lot of ex-US enrollment, those may not be generalizable in the United States; and secondly, patients in the United States do tend to be treated with more therapy, so the fact that this was being demonstrated on top of standard of care in the United States is very encouraging for this agent.

In your opinion, why has icosapent ethyl showed such strong improvement in cardiovascular outcomes while other medications containing EPA have not?

Dr. Scirica: The EPA that was used in the REDUCE-IT trial was a much more concentrated and pure form of EPA, much more, certainly, than we get in fish or in many of the supplemental brands of EPA, and it, I think, is consistent that the degree of purity in the EPA and the reductions in the triglycerides in particular that were seen in this trial are not surprising. It's not surprising that they did result in cardiovascular events. So, I think the combination of a very good potent drug that was studied over a long time period, which is important, in a well-done randomized clinical trial, all led to the benefit that was seen in this trial compared to other trials of lower-dose or shorter studies.

How should icosapent ethyl be used for patients with elevated triglycerides already on statin therapy?

Dr. Scirica: Based on the REDUCE-IT trial, I think icosapent ethyl is an important drug for patients who are on statins, who are at a high risk for atherosclerotic events, and who have triglycerides at least in the 130- to 500-mg/dL range, and, therefore, I think it really should be part of the overall armamentarium of lipid-lowering therapy that we have to use for treating patients.