Dr Matthew Budoff Discusses Final EVAPORATE Results

Through EVAPORATE, we've been able to show at 18 months that patients taking icosapent ethyl (Vascepa) have less plaque and that there is some atherosclerosis regression, marking mechanisms of benefit for these patients, said Matthew Budoff, MD, professor of medicine at the David Geffen School of Medicine at UCLA and investigator at The Lundquist Institute.

Transcript:

The American Journal of Managed Care® (AJMC®):Can you introduce yourself and tell us about your work?

Dr. Budoff: My name is Matthew Budoff. I'm a professor of medicine at the David Geffen School of Medicine at UCLA, and I'm a principal investigator at the Lundquist Institute in Torrance, California.

AJMC®: After 18 months, results show icosapent ethyl (Vascepa) is capable of significantly shrinking plaque in patients with high triglycerides who were taking statins. What is the relationship between the presence of plaque and cardiovascular (CV) outcomes?

Dr. Budoff: We know that atherosclerosis, or plaque in the coronary arteries, is associated with plaque rupture and future heart attacks and strokes. So when the REDUCE-IT trial showed a 25% reduction in heart attack and stroke and cardiovascular death using icosapent ethyl, we wanted to investigate why, or by what mechanism icosapent ethyl may benefit patients. So we undertook the EVAPORATE trial.

AJMC®: Could additional mechanisms contribute to reduced CV events among patients taking icosapent ethyl? If so, do you have any indications as to which mechanisms?

Dr. Budoff: There's been a number of studies trying to look at the overall benefits of this therapy. And I do think that we've been able to demonstrate that it has some anti-inflammatory property and antioxidant property. But that really doesn't explain the robust benefits that we saw. Interestingly, while we use icosapent ethyl for patients with high triglycerides, its effect on triglyceride lowering is not the full explanation. So it's not just lowering triglycerides and lowering events. I think now through EVAPORATE we've been able to show at 18 months, that patients have less plaque, and that there's some atherosclerosis regression, or slowing of progression, that is going to be one of the mechanisms of benefit for these patients.

AJMC®: EVAPORATE only included 80 patients and was not powered for long-term outcomes. Are there plans for larger trials down the line?

Dr. Budoff: Certainly, this was considered a relatively small study with only 80 patients. We did hit all of our endpoints at the end of 18 months, so that was good. We'll have simultaneous publication coming out with more details in the European Heart Journal as the study's being presented. Hopefully people can get a little more information about the final results. But I agree with you, we need larger studies. We are starting a larger trial now to look at plaque changes over time. Hopefully that'll provide us with both confirmation of the first study, as well as a larger study to look at some of the subgroups: men versus women, diabetics versus non-diabetics, to try to figure out exactly who benefits the most and how big the benefit really is.