[HN Gopher] EpiPen For Heart Attacks? Idorsia Launches Phase III...
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EpiPen For Heart Attacks? Idorsia Launches Phase III Study Of
Selatogrel (2021)
Author : bookofjoe
Score : 86 points
Date : 2024-03-28 12:27 UTC (10 hours ago)
(HTM) web link (scrip.citeline.com)
(TXT) w3m dump (scrip.citeline.com)
| jdawg777 wrote:
| > will be supplied with an auto-injector, containing either 16mg
| of selatogrel or a placebo liquid formulation.
|
| Its unfortunate that half the trial patients are getting a
| placebo, especially when it is life or death, but I suppose
| that's how drug trials work.
| crubier wrote:
| This is how all drug trial works.
|
| And it regularly ends up being not-so-unfortunate, when the
| drug turns out to have dangerous side effects that overshadow
| its benefits.
| throwup238 wrote:
| Not all. The need for a placebo control is weighed against
| ethics and whether a placebo is even realistic.
|
| Chemotherapy drug trials often just use standard treatments
| as a control group. They're likely using placebo here because
| there's no other drug in its class yet. Normally emergency
| life or death trials don't have placebos unless the treatment
| is the first of its kind.
| ano-ther wrote:
| Yes. And placebo control is actually quite a weak standard
| (= better than nothing). Ideally, there should be more
| head-to-head studies.
|
| Alas, they are also more likely to fail (and give the
| competition data) so developers avoid them, at least for
| the initial approval.
| LorenPechtel wrote:
| And it's something the FDA shouldn't be allowing.
|
| You want to bring a new drug to market, you should be
| required to demonstrate that it's not strictly inferior
| to existing options in at least some patients. I'm fine
| with a head-to-head that comes out a tie (competition is
| good for the marketplace) and I'm fine with a drug that
| only works in a subset if that subset can be identified.
| And I'm fine with a drug that doesn't work as well but is
| more tolerated. I'm not fine with a drug that loses in
| all respects in a head-to-head.
| stephencanon wrote:
| The standard joke here is that the researcher objects to the
| need for a trial, saying "that would be condemning half my
| patients to death!" and a medical student asks "which half?"
| bookofjoe wrote:
| FWIW, often a trial is halted before being completed if
| statistical analysis of the preliminary results definitively
| indicate a positive outcome, or unexpected negative/life-
| threatening side effects emerge at an unacceptably high
| incidence.
|
| If the trial is halted prematurely because the drug is deemed
| effective, immediately all individuals who received placebo are
| given the real thing. If the trial is completed and it shows
| the drug is effective, all those who received placebo are given
| the real thing.
|
| Know also that all participants are paid for participating.
| Temporary_31337 wrote:
| So are they going to wait with their heart attack until trial
| is over? Maybe read the article first? This makes sense for
| long term medicine like diabetes drugs etc but this one is
| for heart attack
| bookofjoe wrote:
| Yes. That is how clinical trials work. I have run many
| clinical trials. I read the article twice before I
| submitted it.
| epcoa wrote:
| I think the charitable interpretation of who you are
| replying to is that it would be silly to give this drug
| for an acute event to people that received control (a
| life-long standard anti-platelet) weeks after they had an
| MI event. You're not going to say, oh that guy that had a
| heart attack and PCI 4 weeks ago who is on DAPT, oh now
| we're going to give this drug, the horse has already left
| the barn so to speak and the intervention is no longer
| indicated. That's how I interpreted the point at least.
| LorenPechtel wrote:
| Suspect heart attack--you head to the hospital pronto. The
| trial involves injecting the drug immediately, then going
| to the hospital. The placebo arm gets exactly the same
| treatment everyone would get now--rush to the hospital.
| This drug is purely about trying to keep the heart alive
| long enough to reach the hospital. A hospital with a cath
| lab is a far better treatment than this drug--but you can't
| put that in your pocket.
| jprete wrote:
| The alternative is to see later studies like [1], which finds
| that several popular heart interventions don't actually improve
| all-cause mortality in the population of "severe but stable"
| heart disease patients.
|
| If stents and coronary bypasses don't increase life expectancy
| (or quality of life!) for that population, then a lot of people
| from that population took the risks of major surgery for no
| benefit.
|
| [1] https://med.stanford.edu/news/all-news/2019/11/invasive-
| hear...
| sp332 wrote:
| Off the top of my head, maybe the shock of being jabbed with a
| needle would have an effect on people's symptoms that should be
| controlled for.
| bookofjoe wrote:
| It IS controlled for: ALL participants get jabbed with a
| needle.
| sp332 wrote:
| Right, that's why you need to load some needles with a
| placebo.
| bookofjoe wrote:
| Participants receiving placebo get the placebo through a
| needle.
| sp332 wrote:
| Yes. I'm in favor of this.
| LorenPechtel wrote:
| But you don't know if the new drug is going to be better or
| worse. Sometimes the placebo arm has a better outcome than the
| drug arm.
|
| And, unfortunately, sometimes they really mess up the
| statistics. Consider that huge trial from some years ago that
| declared hormone replacement for menopause symptoms definitely
| bad. No, despite the huge size of the study they made a
| fundamental mistake in recruiting participants--all that study
| actually proved is what was long known: fat women shouldn't be
| on hormone replacement.
| binarymax wrote:
| Here's the ongoing trial info:
| https://clinicaltrials.gov/study/NCT04957719
| bedobi wrote:
| pretty sure at least in Sweden they use EpiPens for a bunch of
| stuff, including heart attacks already?
| percutaneous wrote:
| Ahh yes, nothing treats heart hypo perfusion quite like forcing
| the heart into overdrive and massive vasoconstriction. Why is
| the US so far behind on this???
|
| Edit: sorry I was getting technical. Yes it absolutely has a
| role in cardiac arrest and it's used for this the world over.
|
| It would be very detrimental in a patient with a heart attack
| without arrest though due to increasing cardiac demand when
| cardiac supply is already highly limited
| ejstronge wrote:
| > Ahh yes, nothing treats heart hypo perfusion quite like
| forcing the heart into overdrive and massive
| vasoconstriction. Why is the US so far behind on this???
|
| This is actually quite reasonable, especially if it's paired
| with an existing defibrillator. Epinephrine is part of the
| advanced, cardiac life support algorithm, but it's just not
| used in a pen format, since ACLS is typically performed in
| the hospital setting.
|
| https://cpr.heart.org/-/media/CPR-Images/CPR-Guidelines-
| Imag...
|
| Edit:
|
| Recently, in the news, there was a discussion of using ECMO
| in the setting of patients who would require CPR. Take a look
| at this article for more:
| https://www.nytimes.com/2024/03/27/magazine/what-to-know-
| ecp...
| refurb wrote:
| Cardiac arrest is not the same as cardiac hypoperfusion
| (what people commonly call a heart attack), but it can a be
| a consequence of it.
|
| Heart attacks are due to blockage of blood flow to the
| heart. That can cause the heart to stop (cardiac arrest)
| but not always.
| nkozyra wrote:
| Aren't epipens used sometimes to restart the heart after
| cardiac arrest, though?
|
| I don't think it's the first tool from the toolbox, but I'm
| pretty sure epinephrine has use here.
| dghughes wrote:
| I'm not a doctor or in the medical field but I've read
| injected lidocaine is used to treat ventricular
| fibrillation.
|
| I don't know if it's true but I am sure I also once read
| that lidocaine can cause a heart attack but if having one
| can help stop the heart attack.
| percutaneous wrote:
| It's not often used for what's classically considered
| heart attacks, but it's a fun drug that can both cause
| and fix certain arrhythmias!
| epcoa wrote:
| Ventricular Fibrillation is not a heart attack (heart
| attack is already an imprecise lay term) but I don't
| think encouraging it's use for anything other than acute
| myocardial ischemia is a good idea. In that sense,
| lidocaine doesn't stop a heart attack. A heart attack may
| lead to arrhythmias like VF. But VF is not a heart
| attack.
|
| Lidocaine is a sodium channel blocker, it controls
| arrhythmias by blocking or diminishing the disorganized
| electrical activity going on in heart while hopefully not
| squelching whatever remaining dominant organized
| pacemaker activity there is. It is not the only
| antiarrhythmic though and relatively not a common one
| even for VF, it is not generally first line in its class.
| It's role in life support is a complicated subject but it
| is an optional drug for use in in-hospital CPR (ACLS) for
| VT/VF. High quality CPR and defibrillation are far more
| important though.
| ImHereToVote wrote:
| I wonder if it would be possible to inject the heart with
| liposomal ATP directly.
| robbiep wrote:
| Even a cursory exploration into the physiology of atp would
| demonstrate the ineffectiveness of this method - the heart
| consumes around 6kg of ATP daily, or 250g an hour, which means
| you'd need to provide it with more than 4g a minute just to
| stay pumping in isolation. Which then leads to the issue of
| actually delivering the ATP to the correct part of the heart
| (god forbid you have a posterior infarct), and ensuring enough
| of a quantity to keep pumping after that first bolus dose of
| ATP, which isn't going to spread far given the lack of a
| distribution system since there's some blockage upstream
| epcoa wrote:
| This title appears to be confusing based on a comment: Selatogrel
| has nothing to do with epinephrine from a pharmacological
| standpoint. It acts more like a super potent quick acting (and
| deactivating), less blunt aspirin, an anti-platelet / anti
| clotting drug. The comparison to epipen is just the physical
| delivery.
|
| Epinephrine is not used for heart attacks (MI) directly, but can
| be used for cardiac arrest.
| blackhaj7 wrote:
| Definitely confusing. I read it as though I could use my epipen
| if I had a heart attack (which feels like the opposite of what
| you should do)
| bookofjoe wrote:
| When I posted the article on HN I put EpiPen in quotes to
| make it less click-baity; HN's software removed the quotes,
| thus making it both confusing and click-baity. I tried....
| giantg2 wrote:
| Epinephrine does constrict small vessels, but I think it
| dialates the larger ones. Perhaps there would be some benefit
| there. Although an increased heart rate would be very bad if
| the dilation and increased BP wasn't able to put enough blood
| past the restriction.
| babypuncher wrote:
| I didn't find it confusing. The headline had me thinking "a pen
| that instantly delivers a life saving drug in the event of a
| heart attack". The EpiPen is a point of comparison most people
| are familiar with. The name of the actual drug is even right
| there in the title (Selatogrel)
| epcoa wrote:
| > I didn't find it confusing.
|
| Ok? As stated, other comments already had exposed there was
| confusion.
|
| > The name of the actual drug is even right there in the
| title (Selatogrel)
|
| Many non-experts are aware of the general practice of drug
| companies patenting "repurposed drugs" or that the same
| medications are marketed under different names for different
| indications (eg Ozempic, Wegovy and Rybelsus are all the same
| medication). I wouldn't expect most non-experts to
| immediately know that selatogrel is a generic and not a brand
| name, especially when it is being said in the same sentence
| as a brand name. It is quite forgivable to assume it might be
| an alternative trade name for an epi-pen.
| starttoaster wrote:
| It seems like it's maybe obvious what they were getting
| across to medical layman like you and me. Seems like it's
| less obvious to people that are a bit more in the know on
| medical jargon.
| epcoa wrote:
| The opposite. Those, "in the know", know that selatogrel is
| an anti-platelet medication even if they haven't heard of
| it specifically as there is standardization to naming of
| pharmaceuticals (the -grel in this case). The thing about
| things that "are obvious" is that they are only that way to
| a subset of individuals. There were evidently medical
| laymen that were confused.
| starttoaster wrote:
| Ah, well I guess it just comes down to one's ability to
| read between lines, I guess. More specifically, the
| ability to read for the writer's intent rather than what
| is plainly there. I was just trying to come up for a
| nicer explanation to people that seem to know a lot more
| about medicine and medical terms than me being so
| confused by the title.
| krunck wrote:
| Ah yes: https://www.youtube.com/watch?v=jpMxpzfSRUA
| westurner wrote:
| Almost otoh, but fwiu: a Vape Pen with (which) cannabinoids may
| be a helpful immediate intervention for ischemic Stroke?
|
| Smoking increases risk of stroke and heart attack (MI: Myocardial
| Infarction).
|
| Cannabis [smoking?] is _associated with_ heart disease and MI in
| some studies but that could be confounding e.g. preexisting
| hypertension and other lifestyle factors.
| westurner wrote:
| (This is relevant to cardiothoraic and geriatric medicine.)
|
| Why don't I just sell AEDs here. AEDs are also a heart attack
| intervention. It looks like AEDs are about $800-$2000 USD.
|
| AED: Automated External Defibrilator:
| https://en.wikipedia.org/wiki/Automated_external_defibrillat...
| TylerE wrote:
| I suspect we will be. They were virtually unheard of a decade
| ago (and I think the cost was closer to $10k then) but are
| now more or less standard kit in new commercial construction.
| tjohns wrote:
| You absolutely can buy AEDs for home use, and if you're high-
| risk it might even be a good idea.
|
| The only reason it's not recommended more widely is cost
| (they also need regular maintenance) and likelihood of
| actually _needing_ it making it a poor medical value for the
| general population.
|
| (This is also predicated on having people around who are
| trained to use the AED. If you life alone or your
| family/roommates don't know how how to use it, it's useless.)
| carbocation wrote:
| The phrase "auto injector" would have been a much more helpful
| substitute for "EpiPen" here.
|
| > Selatogrel is a P2Y12 receptor antagonist
|
| So this is basically like chewing on ticag, but faster.[1]
|
| 1 =
| https://jamanetwork.com/journals/jamacardiology/fullarticle/...
| babypuncher wrote:
| Most people don't know what an auto injector is. Everybody
| knows what an EpiPen is though.
| carbocation wrote:
| I agree with you that EpiPen is far more widely known. But
| (in my opinion) the ambiguity in the title is not worth the
| name recognition.
| caycep wrote:
| these antiplatelets help a little bit w/ overall risk reduction
| after a heart attack, I'd say, but the big game changer would be
| a clot buster like an injectable version of
| alteplase/tenecteplase or something like that. The caveat is that
| the better it is at reversing clots, the higher risk of
| hemorrhage; alteplase/tenecteplase is typically given in a
| critical care/emergency Dept setting w/ surgery/intensivists
| hovering over the patient...
| et2o wrote:
| None of these works nearly as well as angioplasty
| caycep wrote:
| yes but tpa/tnk is way closer to an angioplasty than
| selatogrel...
| anotherboffin wrote:
| If I remember correctly, part of the goal here is to gain a bit
| of time while the patient gets to the ER. I'm no expert but as
| you seem to have alluded to, the risk profile of
| alteplase/tenecteplase doesn't seem to be well suited to an
| autoinjector with "if in doubt, use it and call the ambulance"
| instructions.
| caycep wrote:
| yeah but then it'll have to compete w/
| aspirin/clopidogrel...meaning they're limited on the margins
| they can set for the med, and injectables tend to be
| pricey...
| carlsborg wrote:
| This gentleman, Jean-Paul Clozel, exited to Johnson and Johnson
| for $30 Billion _cash_. Ex Roche, founded Actelion
| Pharmaceuticals with his wife in a rented lab and developed drugs
| for rare diseases.
| esel2k wrote:
| I worked for him and also on the P2Y12 receptor antagonists.
| What I find impressive is that it is his own money that he
| pumps into it now as the new company is struggling to survive.
| However the company was stretched very thin in too many disease
| areas for the size, most of my friends lost their job in the
| last 6 months. Glad to see some news as the share price is very
| low currently.
| pipes wrote:
| I've recently started keeping aspirin in my pockets because I've
| been getting unexplained horrible chest pain issues. I'm only in
| my forties.
| SketchySeaBeast wrote:
| You, uh, don't want to get out ahead of that a bit?
| Arrath wrote:
| My friend you're going to want to get that checked out.
|
| My dad thought he pulled a muscle in his chest and popped some
| aspirin and kept truckin', in was only later when his leg
| started swelling and turning all kinds of nasty colors that he
| bothered to go to the hospital.
|
| Turned out that a workplace injury had resulted in DVT, and he
| had gritted his teeth through two pulmonary embolisms.
|
| Still kicking to this day, largely in thanks to him finally
| getting the issue looked at.
| ww520 wrote:
| Go to hospital to get it checked out right the way. Go to ER if
| needed.
|
| Your body is desperately trying to tell you something. Listen
| to it.
| pipes wrote:
| I went to A&E (ER in the UK). They did two ECGs and said they
| thought I was ok. A month a go I discovered I'm borderline
| anemic (a consultant hematologist diagnosed this) but I've
| been told chest pain unrelated because that only happens with
| severe anemia. God knows what's wrong. I was sitting in my
| car, and it feels like a fist pushing into my chest.
| Madmallard wrote:
| Sounds like angina. You're gonna want to get that more
| thoroughly evaluated. Stress test, blood work,
| echocardiogram, chest xray, etc...
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