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Ray Kausik Part 7, PCSK9 Inhibitor Side Effects

In part 7, the conclusion of this Exclusive Interview, Dr. Ray Kausik talks with Diabetes in Control Publisher Steve Freed during the ADA 2017 convention in San Diego, CA about the side effects so far of the new inhibitor drug and watching for reactions.

Ray Kausik, MB, ChB, MD, is Professor of Public Health in the Department of Public Health and Primary Care at Imperial College London as well as Honorary Consultant Cardiologist at the Imperial College NHS Trust.

Transcript of this video segment:

Freed: Every drug has side effects.

Kausik: Absolutely.

Freed: What have you seen with these new drugs?

Kausik: So for the monoclonals, they are actually remarkably clean. You see about two or three percent of people that have injection site reactions, but we’re talking about, not big weals in your leg, we’re talking about a little bit of redness which people document as an adverse event but that is actually pretty well tolerated. We haven’t seen any adverse events on cognitive function. We haven’t seen any liver function test abnormalities, any skeletal myalgias, which the statins have…

Freed: And how long has this been in the market? Over time, we have a tendency…

Kausik: Yeah, you’re right. About a year and a half is what we’ve got. But there’s probably globally about a million prescriptions overall…

Freed: But none longer than two years?

Kausik: No. And we’ll have to wait and see over time what happens there. Basically because of the way, unlike a small molecule which is what a statin is, which goes into potentially every cell in the body,  this stays in the blood system. It stays in the vasculature, because it’s a monoclonal antibody and it’s targeted for one thing, it doesn’t cross the blood-brain barrier for example, it won’t go into other tissues. It’s removed by the reticuloendothelial system so we haven’t seen an issue as such with this. I guess the only other thing that people think about are antidrug antibodies. We’ve had two and a half years’ worth of follow up with the fully human monoclonal antibodies and either you see very little or even if you see some, you know it’s like 1%; it doesn’t result in other immune side effects or even an attenuation of the benefit. There was a humanized form called Bococizumab, which has now been withdrawn because with this version, it was 90 percent human, 10 percent mouse, they found over time, antidrug antibodies developed, which increased and that led to a reduction in the efficacy of the drug. So after a couple years, you’re probably not getting anything over and above placebo. So, that’s been taken off, so the only two drugs that we have are the fully human.

Freed: So we can actually put this in our water supply?

Kausik: You need a bit more than that because you have to inject it. Unfortunately it’s a large molecule, if you ingest it, your gut enzymes will break it down. It has to be injected sadly. (Laughs)

Freed: That’s the first time I’ve heard it’s a drug. At this point we haven’t seen any bad reactions from it, but aren’t there always people who have an allergic reaction to it?

Kausik: I mean the early phases, there was only one patient that had some sort of immune reaction, but then we’ve had 5,000 people, with additional information since then, we’ve not seen it. So, if you study a million people, there will be one, the question you’ve got to ask yourself is, what’s the risk-benefit ratio? The risk of adverse side effects is actually really low. Yes, you’re absolutely right, the longer you follow these people up, the more you’re likely to see something but, that’s true of every drug that we’ve ever developed. The longest follow-up of most of these drugs we’ve had is five years or so but we’re going to be offering these treatments for life.

To view other segments in this video series:

Part 1: PCSK9 Inhibitor Treatment For Diabetes

Part 2: PCSK9 Effect On HDL Goal Levels

Part 3: PCSK9 Effect On Lowering Cardiovascular Death

Part 4: PCSK9 And SGLT2 Combination Therapy

Part 5: PCSK9 Inhibitor Cost

Part 6: Good Versus Bad Cholesterol