Considering Cost Effectiveness in Cardiovascular Risk Reduction - Episode 14

Implications for Treating Patients With Icosapent Ethyl

Health care professionals consider how to adopt data demonstrated by trials such as REDUCE-IT into clinical practice when considering icosapent ethyl as treatment for patients with diabetes.

Transcript

Deepak L. Bhatt, MD, MPH: There are lots of guidelines that focus on LDL [low-density lipoprotein] control, but increasingly a number of guidelines have adopted the REDUCE-IT trial data. In fact, the American Diabetes Association [ADA] was the first major organization to incorporate icosapent ethyl for patients with diabetes and also for patients with atherosclerosis. Others have followed: the European Society of Cardiology, the European Atherosclerosis Society, National Lipid Association, and a number of others as well. One thing I might ask Dr Budoff to comment on is some of the more recent analyses from REDUCE-IT, such as the patients with diabetes recently presented at the American Diabetes Association. You were the co-author on that work. What does that tell us that we need to think about in people with diabetes, specifically?

Matthew J. Budoff, MD: Again, going back to the REDUCE-IT design, remember that the primary prevention entry criteria were patients with diabetes, and the secondary prevention included diabetes. I think we learned a lot from that subanalysis. And remember, most of the patients in the REDUCE-IT trial, more than half, ended up having diabetes because they could have been in either the primary or secondary prevention arm. At the ADA meeting just literally days ago, Dr Bhatt presented data that demonstrate that it was as robust a benefit in these patients with diabetes, both for initial events as well as for total events. And the patients who have diabetes and coronary disease have the highest risk and the most absolute benefit, of course.

I want to highlight one other recent study that you presented at another meeting, at the Society for Cardiovascular Angiography and Interventions, because I think understanding what you called REDUCE-IT REVASC was very important in demonstrating both time to PCI [percutaneous coronary intervention] reduced by 32% and time to bypass surgery reduced by 39%. And I do think that’s the first time we’ve seen any therapy reduce the risk of bypass surgery. I think that when we talk about greater than 30% reductions in revascularization on top of that…I know we have experts in cost effectiveness, but those are both expensive and potentially life-threatening interventions. We really have a robust benefit across multiple subgroups in the REDUCE-IT trial.

Deepak L. Bhatt, MD, MPH: I’m glad you brought all that up because beyond the primary results of the trial that we briefly reviewed, there have been subsequent analyses. As you mentioned, REDUCE-IT DIABETES showed robust benefits of icosapent ethyl in those with diabetes, also in those without diabetes who had atherosclerosis. There were essentially 3 subgroups: those with diabetes with cardiovascular risk factors, those with diabetes with cardiovascular disease—that was a really high-risk subgroup with very large absolute risk reductions—and then those without diabetes but with established atherosclerosis. There are 2 that were large risk reductions. I think it’s important to realize that in those patients with diabetes, icosapent ethyl is something to consider if the triglycerides are a bit elevated. But even in those without diabetes, there is benefit.

And the REVASC, as you mentioned, is interesting. I think you’re right. At least in the LDL-lowering era beyond just LDL reduction, I certainly couldn’t find another trial that’s randomized, double-blind, placebo-controlled showing a reduction in the need for coronary artery bypass grafting. I think that shows the large benefit of icosapent ethyl in reducing a substantial amount of atherosclerosis and is really in order with what you showed in EVAPORATE. That is, direct effects on plaque progression rates or even regression of plaque would explain why there would be a reduction in the need for something like bypass surgery. I agree, that is pretty remarkable.