Name:
FOURIER Delivers Hard Clinical Outcomes
Description:
FOURIER Delivers Hard Clinical Outcomes
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T00H06M27S
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Upload Date:
2022-02-28T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
>> Practice Impact Extra podcasts are derived from Hurst's The Heart Board Review and other online resources available only through accesscardiology.com. >> Eagerly, we've been awaiting the results of the FOURIER trial, which is on a little more than 27,000 patients, which is outcome-based, meaning looking at heart attack, stroke, cardiovascular death, revascularization. Did it make a difference in those individuals in this study, the FOURIER study, which was an international study?
Hi. I'm Dr. Bernie, and welcome again to Practice Impact Extra. I'm just back from attending the really informative ACC National meeting in Washington D.C. I wanted to review a very impressive international trial presented at the ACC National Scientific meetings in Washington, the FOURIER trial. This was a trial on PCKS9 inhibitor and was an outcome study. We've been awaiting these results eagerly for some time now.
The investigators of this study randomized 27,564 high-risk patients with cardiovascular disease and LDL levels of 70 milligrams or higher. These patients were already on maximum statin therapy, and then they were randomized to evolcumab or to placebo. The study was monitored and followed these patients for 2.2 years for both the primary and secondary endpoints.
What were the primary endpoints? Well, they included cardiovascular death, myocardial infarction, stroke, and revascularization. The secondary clinical endpoints included cardiovascular death, myocardial infarction, and stroke. So, what do we have? Well, we have some really impressive hard clinical outcomes. First, there was a significant reduction, a 59% reduction, in LDL cholesterol in the evolcumab-treated patients compared to the placebo.
And indeed, the mean was 92 milligrams before therapy, down to 30 milligrams at one year. And let me stress something I think is very, very important when you look at these drugs. It is important to note that did these values, the LDL low values, remain throughout the entire study? Because you're going to see some -- that this is not a class or group, and in each individual on a PCKS9 inhibitor may indeed have different outcomes related to its effect on LDL cholesterol throughout the entire study.
The secondary primary endpoint demonstrated a 15% reduction. And when you looked at the more serious secondary endpoints, those being the CV death, MI, and stroke, there was a 25% reduction. Those are big numbers. To note, when they looked at the analysis even closer, the CV death, MI, and stroke rate in the first year was 16%. In the second year, it rose to 25%, suggesting that the curves are diverting and we were having sustained benefit in secondary outcomes and clinical hard points that continued to increase with time.
I think that's very, very important. And what about the individual outcomes? Well, the overall mortality was really not different between the two groups, but I think that is because of, number one, a maximum amount of good therapy that was already at baseline. But more important, this was a short study of 2.2 years. That clearly is -- in a lot of the studies that we have on statin trials and outcomes, 2.2 years would be a very short period of time to see dramatic outputs -- dramatic outcomes in the overall mortality.
When we looked at the individual outcome of heart attack, it was reduced 27% in-- in the treated group, stroke was reduced 21%, and revascularization was reduced 22%. So, what about safety? I mean, that's got to be a clear issue here, and we were getting levels that are really way down. And so, what about it? Well, the treatment with the evolcumab did not -- let me repeat -- did not result in a significant increase in adverse events including no new-onset diabetes and no change in neurocognitive events.
I think that's fairly important. So, is there any concern? Well, yeah, there's one big concern, the cost. The cost is approximately $14,000 per year. And so, there's a lot of discussion about, you know, how can we afford this? And really what I think we'll need to do is to see a longer trial. And indeed, there's going to be a longer trial that's ongoing right now and once again an international study, the ODYSSEY trial, and this is going to be a four-year trial that will be reported probably within the next year or so and another study on a PCKS9 inhibitor, but this time in acute coronary syndrome, and I think we'll get a lot more information in relationship to the cost and treatment issue.
And so, we'll wait for that trial. So, what's my take? Well, I believe that patients at high risk are at a significant risk of nearly 5% mortality every year. All the data reinforces lower-is-better LDL cholesterol hypothesis. So, I think adding a PCKS9 inhibitor treatment to those individuals leads to improved clinical outcomes without any major effects or adverse events.
Thanks, and I hope you'll be back for the next Practice Impact Extra. >> We hope you enjoyed this podcast from McGraw-Hill. Subscribers to AccessCardiology have instant access to over 25,000 pages of rich medical content, receive medical updates from trusted experts, and have access to other special features. To subscribe or learn more, please visit accesscardiology.com.
