Michael Miller, MD, Discusses the REDUCE-IT Trial

Michael Miller, MD, professor of cardiovascular medicine at the University of Maryland School of Medicine, discusses the REDUCE-IT trial, a ground-breaking study that was the first clinical trial to look at the people with high triglycerides, who were already well-controlled from the standpoint of having a good LDL, being treated with statin therapy.

Transcipt:

First Report Managed Care: To begin, can you tell us a little bit about your background and current position?

Dr Miller: I'm a professor of cardiovascular medicine at the University of Maryland School of Medicine. I've been in the field for 30 years, and my specialty has been in preventive cardiology. I'm a cardiologist by training and with a special interest in lipid disorders.

I've had a long-standing experience and a focus in people with high triglycerides, so I've been around.

First Report Managed Care: Regarding the REDUCE-IT study, can you tell us about the REDUCE-IT trial, the study results that were just presented at AHA Scientific Sessions, and what they mean for preventative cardiovascular care?

Dr Miller: Sure. This is really a ground-breaking, unprecedented study in the sense that this is the first clinical trial to look at the people with high triglycerides, who were already well-controlled from the standpoint of having a good LDL, being treated with statin therapy. We've known for many years that a high triglyceride raises risk of heart disease, but we had no study specifically to evaluate this population.

The study was designed to look at patients that already had established heart disease, or did not have to have established heart disease, but they had to have diabetes and at least one other risk factor associated with that diabetes.

We treat it with a statin so their LDL levels were under control, and all they had was a residual triglyceride. They were then assigned to either this pure EPA compound known as icosapent ethyl, which is a highly purified EPA, or a placebo, and followed for close to five years.

The results of this study indicated significant reductions in the primary end point, which was major adverse cardiovascular events, and that is heart attack, stroke, cardiovascular death, hospitalization for unstable angina, or re-vascularization.

On top of that, they also had significant reduction in secondary end point, the secondary end point being cardiovascular death, non-fatal MI, and stroke. We did a whole bunch of different analyses and virtually everything was positive.

In other words, there was reduction in unstable angina, reduction in cardiovascular death, which was really important because this is the first clinical trial in the statin era to show benefit, on top of a statin, in terms of reducing cardiovascular deaths, so it's a big deal.

First Report Managed Care: Can you tell us more about the patients who would benefit from treatment with VASCEPA? What are their current options for a therapy, and how do they compare with VASCEPA?

Dr Miller: There are, in the United States alone, at least about approximately one out of five men and women have a triglyceride that is viewed as high, which is above 200, somewhere above 200. Right now, we don't have much in the way of options for those individuals.

There are no approved products short of statin therapy, which really doesn't do a whole lot for triglycerides. This icosapent ethyl lower triglycerides by about 20 percent, so we think that there is not only a lot of people that have high triglycerides, but also a lot of people with heart disease and diabetes that might benefit from this drug.

We're looking at millions of people. We're not looking at a few hundred people. We're looking at 10 to 20 million people who might benefit from this drug.

First Report Managed Care: Can you talk about the results related to reduction in hospitalization, and the need for coronary re-vascularization? How do these results impact the overall value of VASCEPA therapy?

Dr Miller: I think that all these end points were improved somewhere approximately 25 percent. The number needed to prevent one of these events, whether it's an episode of hospitalization or a heart attack or stroke is about somewhere in the 20s. Out of every 20 to 25 people you treat, you're going to prevent one event.

This is dramatic because the PCSK9 inhibitors that you inject, you need to treat about 50 people to prevent an event. Here, you're treating somewhere in the mid-20s to prevent an event.

It's a practice-changing medicine. It's a practice-changing study with a practice-changing medication for a patient population that traditionally has not been well-treated.

First Report Managed Care: Did you have any other additional comments or points that you wanted to add about the REDUCE-IT study? Anything of note that you want to mention?

Dr Miller: I will tell you that I think it's going to change the way we practice medicine. I can tell you that at the American Heart meetings, they did a poll before the presentation of REDUCE-IT came out.

There were about 5,000 physicians, cardiologists, in attendance, and they asked, "How many of you would now treat patients with hypertriglyceridemia with medication?" About 20 percent said they would, or they do.

After the presentation, close to 90 percent said they would. It was a dramatic response.

I think once the word gets out...There needs to be a lot of education. A lot of physicians are not as well-versed in this area of hypertriglyceridemia, so I think there is no question that this is a key change in the way we practice medicine.