Unpacking what Positive Headline Results Mean in a Repatha Study

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Dr. Michael Koren joins Kevin Geddings to discuss the positive headline results from a clinical study on the cholesterol medication Repatha. Dr. Koren explains what "headline results" are and how they differ from results presented in a full scientific format. He talks about how these findings are being released due to market regulations to keep the parent company of Repatha, Amgen, from violating financial laws. Dr. Koren also explains that these results are encouraging for people with high cholesterol. The study was using Repatha as a potential preventative medication and preliminary results are looking good!

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Episode Transcript

Announcer (00:00):
Welcome to the Me dEvidence! Monday Minute Radio
Show, hosted by Kevin Geddingsof WSOS St.
Augustine Radio and powered byEncore Research Group.
Each Monday morning, Dr.
Michael Koren calls in to bringyou the latest medical updates
with insightful discussions.
MedEvidence is where we helpyou navigate the real truth
behind medical research withboth a clinical and research

(00:21):
perspective.
So sit back, relax, and getready to learn about the truth
behind the data in medicine andhealthcare.
This is MedEvidence!

Kevin Geddings (00:31):
Very interesting early preliminary results from
a study that involved folksright here in St.
Augustine, right, Dr.
Koren?

Dr. Michael Koren (00:37):
Yeah, yeah.
This past week there was therelease of what we call top-line
results for a study called theVesalius Study, which is a study
of a drug called Repatha.
People may have heard thatbecause it's a drug that's
actually been on the market fora while.
In fact, our group has workedvery extensively on developing
this drug, approved by the FDAin 2015.

(01:00):
But what we didn't know aboutthe drug, Kevin, was whether or
not it helped prevent the onsetof a first heart attack or a
first stroke.
So previous study showed thatin fact this drug Repatha
reduced heart attacks andstrokes in people who are known
to have had previous problemswith either heart disease or
stroke or peripheral arterialdisease.

(01:20):
But this study was actuallylooking at people, and it was
conducted in St.
Augustine, as you mentioned,looked at people who are
actually not yet diagnosed witha heart attack or stroke.
And what it found, again, justthe top line, is that indeed the
drug was effective, that whenyou use this drug on top of
statins by and large, that itprevents the development of a
first-time heart attack andstroke.

(01:42):
So we're excited about that,but there's there's some nuances
here.
Which is one, when they releasethe results, they didn't
release it in a full scientificformat.
In fact, we're all waiting forthat full scientific format to
be released at the AmericanHeart Association meeting, which
is coming up next month.
But because the sponsor forthis program is Amgen, they have

(02:05):
an obligation based onsecurities law to release what
they know about a major study assoon as they know about it,
even if they don't give all thedetails.
So it's fascinating is thathere here I am just at my
computer and all of a sudden Iget this notification that in
fact the top line of this studyhas come out and it is positive

(02:25):
for the drug Repatha.
And this is driven actually byfinancial market issues, not
scientific issues.
But we'll get a lot moreinformation about it in a
scientific forum next month atthe American Heart Association
meeting.

Kevin Geddings (02:38):
Right.
And Dr.
Koren, not to get too much intothe weeds, but what does
Repatha actually do in ourbodies?
I mean, what's it doing to helpus out?

Dr. Michael Koren (02:45):
Sure.
Well, Repatha is a cholesteroldrug that's called a PCS K9
inhibitor.
And what that does is it helpsour liver cells remove
cholesterol from thecirculation.
And it's extremely effective.
So when you use this drug,it'll lower your LDL cholesterol
by about 60%.

Kevin Geddings (03:03):
Wow.

Dr. Michael Koren (03:04):
So uh we've known that it's an extremely
effective drug.
As I mentioned, we've knownthat it works really well with
statin drugs, and for somepeople they can't take statins.
But what we did not know waswhether or not it can prevent a
first heart attack and stroke,but now we know that.

Kevin Geddings (03:18):
Right.
Well, and this uh data thatwe're sharing with folks this
morning, of course, does involvefolks who participated here in
the St.
Augustine office ofENCORE Research Group, right?
And that's that's exciting.
That points to all sorts ofother opportunities for our
local listeners to participatein leading edge clinical
research, correct?

Dr. Michael Koren (03:35):
Yeah, it it it's it's definitely one of
those things that I considerpart of the value proposition
for participating in research.
So when you're in a study likethis, it's a longer term study.
So this has been been going onfor 4 or 5 years.
You get a lot of attention,obviously, all this is free of
charge, and we actually pick upsome expenses for you.
And uh during this, you kind ofhear the story about this drug

(03:56):
and why we're studying it, andget little tidbits about your
health along the way.
And then lo and behold, theanswer to the story comes out,
and everybody gets super excitedabout it.
So we'll of course have to havesome sort of celebration.
But uh to your point, um, theseopportunities exist as we
speak.
And there are other studiesthat are doing similar things
that are also trying to see whathappens to people, what

(04:17):
benefits can they expect whenyou get your cholesterol levels
down to really, really lowlevels, or when you get that
lipoprotein little A down tovirtually nothing.
Right.

Kevin Geddings (04:26):
Well, once again, if you have uh an
interest in this, but reallyjust about any health care issue
you may have, any chroniccondition you may be dealing
with, uh odds are there is astudy going on or there is a way
for you to participate.
So we encourage you, really, uhif you've been listening to us
all these Mondays and youhaven't made this phone call,
call and learn how you canparticipate uh in some of this

(04:47):
research and benefit from it.
And to be honest, get some ofthe best health care you'll ever
experience.
Both myself and also Karen andour team here have participated
in studies atENCORE Research Group.
Go to Encoredocs.com,E-N-C-O-R-E, Encore Docs.com.
And we can't let you go withouttalking a little bit about
MedEvidence, right?
Go to medevidence.com.
What do they go to find, Dr.

(05:07):
Koren, on that platform?

Dr. Michael Koren (05:09):
Oh, you're gonna find literally hundreds of
interviews with leadingphysicians from around the
world.
And it's an interesting formatwhere two knowledgeable
physicians just chat about amedical issue.
And we basically tell you whatwe know about a particular
issue, the things we don't knowabout the issue, and then how
we're gonna learn about thisissue through clinical trials

(05:30):
and other types of research.
So uh it's a fascinatingformat.
I'm getting tremendouslypositive feedback on it.
People love sort of the laidback, honest approach to medical
issues rather than just tryingto sell you something.
We really help you analyze itso you can make good decisions
for yourself and your family.

Kevin Geddings (05:46):
Yeah, well, this is great.
Well, once again, check outthat website, medevidence.com,
and check it out before you relyon what you're gonna see on
Snapchat or Instagram orFacebook.
Go to medevidence.com, theTruth Behind the Data,
Encoredocs.com.
And if you're interested inthis research that we've been
talking about and you have ahealth condition, we encourage
you once again to call thisnumber here locally in St.

(06:07):
Augustine.
They're located next door to UFFlagler Hospital, 904-730-0166,
904-730-0166.
Dr.
Koren, thank you for all yourtime and good luck to the Jags
tonight, right?

Dr. Michael Koren (06:23):
Absolutely.
Go Jags.

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