How alirocumab fared for patients with polyvascular disease in a subset of the major clinical trial.
New data presented at the American College of Cardiology (ACC) 2019 Annual Scientific Sessions this weekend showed more positive results from the large-scale ODYSSEY OUTCOMES trial assessing alirocumab (Praluent).
The assessment showed the Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was associated with fewer deaths in patients with acute coronary syndrome, versus placebo. Patients with greater LDL cholesterol (≤100 mg at baseline) reported even greater benefits for mortality, investigators noted.
In an interview with MD Magazine®, study author and presenter Wouter Jukema, MD, PhD, professor of Cardiology at the Leiden University Medical Center in The Netherlands, explained that the data—which focused on a patient group who often needs a complex therapy regimen—emphasized the value of a therapy that provides simplified care.
MD Mag: What were the findings of the ODYSSEY analysis for post-acute coronary syndrome patients?
Jukema: Today, I presented the data from the sub-study from the ODYSSEY OUTCOMES trial. It's a huge trial of more than 19,000 post acute coronary syndrome patients. They were randomized to alirocumab—a PCSK9 inhibitor—or placebo. And the interesting thing was they were already well-treated. They received their cholesterol-lowering medication as they should, by the guidelines. They were all on statin therapy. And on top of that, they got additional cholesterol-lowering medication—alirocumab lowers your cholesterol by another 60%.
You could really argue for daily practice, "Is this really necessary? Is it really helpful? Is it worth the issue?" And of course, in the main results, we showed with general additional LDL-lowering, if you do not meet your goals, it clearly has added value.
It lowers your future risk of cardiac events, and it even reduces your future risk of death. Having said that, we're always looking for patients for whom this medication is working optimally. You could try to identify these patients with extra-higher risk, which also qualifies them for additional medication, and have additional gain.
And, you can do this in a very complex way—a complex course of adding this, then adding that. But you could also look at easy to recognize patient characteristics. We did this today. We presented that, by looking at the patient—does he only have coronary disease, or does also have cardiovascular disease somewhere else? Peripheral artery disease, or did he suffer from severe vascular disease, like a stroke or carotid disease?
It doesn't need complex testing. You can just ask your patient, "Did you suffer from a stroke? Do you have any pain in your legs from walking?” And today, we clearly showed that if you have more than 1 vascular event, that your risk goes up tremendously. And for those patients, it's also clear that if you lower your cholesterol additionally, if you're on target, it helps a lot.
So your baseline begins with a population patients that have multiple vascular disease, polyvascular disease, much higher. But what you gain is much more. It's a very easily recognizable group which you can easily treat more optimally.