Wouter Jukema, MD, PhD: PCSK9 Inhibitor Potential, Tolerability

March 23, 2019
Kevin Kunzmann

It's been 4 years since the drug class reached the market. Are patients adhering to the therapy, and what more potential does it have?

At about 4 years old, alirocumab (Praluent) is technically the oldest marketed therapy of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor drug class. But in terms of real-world data assessment, the drug is in its infancy stage.

After more positive findings from a sub-study assessment of the large-scale ODYSSEY OUTCOMES trial were presented at the American College of Cardiology (ACC) 2019 Annual Scientific Session in New Orleans, LA, Wouter Jukema, MD, PhD, discussed the drug’s potential growth and current standing with real-world patients.

In an interview with MD Magaizne®, Jukema, professor of Cardiology at the Leiden University Medical Center in The Netherlands, marveled at the positive patient response to the bi-weekly injection therapy in comparison to previous oral therapies.

MD Mag: Where can we expect alirocumab to expand in its uses and indications?

Jukema: I think we all agree that cost-effectiveness is an important issue nowadays. You can spend any dollar only once in healthcare. If you're spending money on healthcare, you can't afford a new house or anything. You have to really look at optimized healthcare. So that's why we strive to focus on easily recognizable subgroups that have a particularly elevated risk, and may benefit a lot.

There's a lot of these patients around. They're easily recognizable—you don't have to do complex lab testing or whatever. You just look at the patient chart, and then you know. And if you know these patients have a clearly elevated risk, and that these patients can benefit a lot, that's easy. In my opinion, for this type of patient, there's a big bang for the buck.

Are these positive adherence rates among PCSK9 inhibitors?

Adherence is always a very good topic. People are less likely to adhere to medications for something they do not feel. You have to swallow medications for years to benefit at all. You don't feel cholesterol. You will get better, yes, years from now, but sometimes it's cumbersome to convince people to stay on the drug.

When we actually designed the ODYSSEY OUTCOMES trial, we said, "Okay, now you don't have to actually only swallow the pills, but you also need an injection every 2 weeks. To be honest, we thought that would be a possible issue—that people would stop taking the injection.

The interesting thing is that it's the reverse. People easily stop ingesting pills, but injections were very well tolerated, and patients didn't bother at all. On the contrary, we had the idea that finally, something really good was done. Adherence was really excellent.

And that's what I also hear in clinical practice from patients outside the study. Most of these patients are very motivated; they have a high burden of disease, and they're very happy that it works that well. And that they have to take an injection every 2 weeks while they're watching an evening sports show, they don't care.

On the contrary, they even have to inject something that's good, and when they come to me the next day and realize their LDL cholesterol is 60% lower, people are extremely happy with that. We thought compliance would be an issue, but in fact, for this type of medication, it's not.

It's much better than regular pills. I'm not saying we should shift from pills, but for the injections, it works fine.