June 4, 2023

I’m peggy peck medpage today we’ve just been through an extraordinary session at the american college of cardiology negative results for the enhanced trial which we knew since january but explained here in great detail this study is really a negative study provides little new evidence in fact no new evidence to support our use of as etem id and we know that in 2006

Almost one out of six prescriptions for lipid lowering agents where’s atomizer that’s incredible for a drug that was introduced just four years earlier in this study while not definitive in its own right sort of highlights for us reminds us actually how thin the evidence is for is that amide with regard to benefit we know it does great things for the lab result

Whether or not those things translate into benefit for our patients is something that remains not well defined in this study which showed that it did not the progression of atherosclerosis the addition of as edomite to a statin did not the progression of atherosclerosis is surprising and gives us some pause and makes it i think a little less likely that the end

Of the day we’re going to find out that this is a beneficial drug meanwhile the drug makers merck and schering-plough had a very different take on today’s results as dr. robert smigel explained here at a press briefing so speaking for schering-plough and merck i would say that we were very disappointed in today’s acc plenary session it was not the panel discussion

We expected and it was not a balanced discussion and we’re concerned that it did not serve science well and it didn’t serve patients well we know of no safety concerns regarding zetian vytorin and certainly none that were raised by enhanced what we do know a great deal about is the value of lowering ldl and you’ll be hearing more about that from the other panelists

This afternoon i just want to emphasize again that the safety of ezetimibe zetia and when it’s combined with by torrent with joe court to make vytorin can be assured not just because of one comment that was mentioned that the improvement trials data safety monitoring board their dsmb recently looked at the one going data as an independent data safety monitoring

Board and found no signals but we also have experience with over five years and over 10 million patient years of experience with these drugs being very widely utilized and no new safety issues have arisen and continues to perform very well with very good patient tolerance and no signals for new safety concern in my own clinic in amsterdam and i can only speak

For what i do myself we have the largest clinic in the world by far for familial hypercholesterolemia i have eight and a half thousand adults under our care and approximately one and a half thousand children so this is a typical family clinic for them the addition of xena map to statin therapy and this is not load of statin therapy this is the highest dose statin

Therapy is the only way of getting a normal ldl cholesterol so what do i do i wait till i have the results of the improve at trial you know because for many of these families for the first time they come back with their results from the lab and they show me an ldl that’s in the normal range i cannot go back to amsterdam and tell them listen we’ve done a 700 people

Trial and now i’m going to stop as it amide the second part of that question what squatching what you’re going to do for for example primary prevention first prescription secondary prevention i think i have a number of very well distinguished american colleagues who can answer that question much better because i don’t cheat those patients i just treat those patients

With genetic high cholesterol you have a drug that was approved only on the basis of its ldl and for which we really still don’t understand exactly its effect on patients in making the kind of decisions about whether we should be using circus or not i think it has to do with how serious is the underlying disease what kind of alternatives do we have available to

Us and if we are going to end up approving based on these circuit outcomes to what extent are we making sure that people know the strength of the evidence behind it to what extent are we letting patients understand where we stand with regard to our confidence that this drug is eventually going to benefit them and how much do we really know about safety people

May ultimately say i would prefer to try it now i mean i’d john’s patience and by the way i’m my expectation is that you’ve exhausted statin therapy in those patients so he’s talking about a group of patients and who statins have already been used to their grade 6 10 now there’s another medication there’s a probably pretty good bet that many of those patients

With regard to their preferences would say okay i’ll give it a shot but they need to do that with full knowledge of the strength of the evidence so i think it’s a big it would be a big statement to say we should never use surrogate outcomes i mean how long can you wait and how much follow-up do you need but i think they need to be balanced by the understanding how

Serious disease is dr. krumboltz and urinalysis published in the new england journal of medicine he said that the company’s merck and schering-plough spent an estimated 200 million dollars marketing for marketing and advertising of his to draw zetia and vytorin and that currently prescriptions for those drugs account for about 1 in 6 lipid-lowering prescriptions

In the united states for a drug that you’re saying doesn’t have a clear clinical benefit is this an indictment of direct-to-consumer advertising yeah i think that our message together is that people need to turn back to stands we’re all aware that amid the very aggressive marketing campaign the people one is that zetia first came out used it instead of statins

And then as the vytorin came out people are using a combination with a lower dose of statins they hadn’t exhausted the statin option we know that statins are good drugs we know they reduce risk and we believe that in general to get to a five billion dollar-a-year drug there was a lot of movement towards perhaps premature use of ezetimibe before the statin option

Had been exhausted our strongest recommendation is that people need to go back to statins recognize that this is where the evidence is we need to be evidence-based we need to recognize where we’ve got evidence and proof about patient outcomes and that will be all that’s going to best guide us to promote the interests of our patients so that the real message here

Is that we think that there’s probably only a small group of patients who really can’t get the target based on maximizing statins and that’s where we get to this sort of very difficult decision but that everyone should if you were if you were put on this drug before you had an opportunity to be fully treated on statins and you should you should see about things

Were here there actually was resounding applause at the end of your statement and i’m wondering what your sense is that to sense a sense of could a cardiology house yeah i think it was hard to tell when i put together this you know my impressions of this trial and what comments i was going to make but i was i was quite happy to see what really did seem like a

Quite strong round of applause which i think really represented a that my comments resonate with the audience i don’t think it was so much an endorsement of anything in particular except that the themes that were discussed the idea that we really need to stick to evidence the the notion that perhaps amid an aggressive marketing campaign that this may have been

Adopted to a greater extent than the evidence supported resonated with the audience so as we’ve heard negative results for an enormously popular cholesterol-lowering drug for which americans have spent an estimated five billion dollars more to come on this at future meetings i’m peggy peck medpage today

Transcribed from video
ACC: ENHANCE Data on Ezetimibe/Simvastatin (Vytorin) By MedPage Today