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North. Inclisiran doesn't do much to lower TG's ( -12% placebo adjusted ...but it does OK lowering Lp (a). ( -25% placebo adjusted )
Triglyceride (median) -14.9% -2.3% -12.6%
Lp (a)* (median) -21.9% +3.7% -25.6%
First number is on Inclisiran , second # is the placebo , third = placebo adjusted
Orion trial data
Kiwi
The same JAMA article also “highlights” the use of 2 trials, Shasta-2 and Bridge-TIMI 73a, involving injections of inclisiran and Olezarsen to treat hypertriglyceridemia, respectively. The author did say that “neither study told us what it means in terms of pancreatitis or future adverse cardiovascular events.”
Timeline for antitrust suits against amarin?
Looking for feedback .. i have been around for years and not trying to fear monger ..
It seems generics know the supply issue leaves them at amarins mercy on pricing and they realize that breaking amarins hold on epa supply is needed to take over the us market fully.
I think the case is bs - considering where amarin was when signing those contracts - but considering the past history i know longer have faith in the us court system. I still don’t understand how dus ruling held up through appeals all the way to the Supreme Court .. the secondary indications test was clearly used differently in the amarin case than in previous precedent.
So .. i have not found information on a likely timeline for the antitrust cases to progress, i know the dismissal motions were denied. My concern is ramp up ex us sales vs this case’s potential impact on amarins current us revenue stream.
My understanding is appeal on dismissal of Holman inducement should be imminent too.
Phenomenal post Zip. I think it should be bookmarked here or whatever that is called.
The first two things docs tell their patients is: lose weight and STOP smoking. They know the vast majority of their patients will do nothing, but when they can prescribe something to them that removes the negatives (wrt CV events) of smoking, it is a win win. Now if every doc can be instructed in this, and if they still do not prescribe V, then it is malpractice. Great job Zip, and Capt.
The May 14 JAMA issue has an “edited for clarity and length” version of “highlights” from the ACC 2004 Scientific Session, presented in an interview of Dr. Drachman from MGH. Odd that Amarin’s presentations are not mentioned. Pages 1522-24.
In the same JAMA issue, readers will find an article by SE Nissen et al concerning a short trial of the effects of Zerlasiran on lipoprotein(a) serum concentrations. Pages 1534-1543.
DMC...Thank you for posting on these studies on IPE
One study, you linked ,especially caught my interest...It showed the beneficial effects that Icosapent ethyl can have on cardiovascular outcomes in cigarette smokers...Smoking and CVD's is a world wide problem,which can be ameliorated with IPE...
"In REDUCE-IT, IPE treatment was associated with a reduced risk of CV events in current and former smokers to levels observed in never smokers. While smoking cessation should always be recommended, these data raise the possibility that IPE treatment may attenuate CV hazards attributable to smoking"
Thanks for the link! I’ll add that to my list of indexes and databases. You may be interested in these as well?
PubMed (NIH):
https://pubmed.ncbi.nlm.nih.gov/
The TRIP Medical Database:
https://www.tripdatabase.com/
WOW! If you’re interested in research trends for CVD and Lipid Lowering Therapies and who are the most published, cited, and impactful researchers in the field, then this review is in your wheelhouse!
For example, our very own Deepak Bhatt is the 3rd most published author in the last 30 years in this field, and among the most impactful. His publication, “Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia (REDUCE-IT)” in NEJM was the 5th most cited article in the past 30 years!
There’s a lot here if you’re a stat nerd.
2023 to 2024 EPA related publications.
https://www.epistemonikos.org/advanced_search?q=Icosapent%20Ethyl&protocol=no&min_year=2023&max_year=2024
The NIGUARDA hospital in MILAN is among the best hospitals in ITALY
Icosapent Ethyl – A Successful Treatment for Symptomatic COVID-19 Infection
Published 09/02/2020
Whenever COVID season hits, a timely reminder.
https://assets.cureus.com/uploads/case_report/pdf/39133/1612431048-1612431042-20210204-30437-162bze1.pdf
*NOTE: Italian Hospital & Italian Researchers. I suspect we're getting closer to Pricing & Reimbursement in ITALY! Furthermore, this observational study contradicts arguments proffered by Germany that if REDUCE-IT had included more patients on higher intensity statins, (thus lowering the bar for LDL-c), that the results would not have been as robust as it was. This study and those presented at ACC24 have demonstrated that IPE benefits extend beyond LDL-c, TG, and Lp(a) levels.
Front. Pharmacol., 17 May 2024
https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1393333/full
European Heart Journal Supplements, Volume 26, Issue Supplement_2, April 2024, Page ii29, https://doi.org/10.1093/eurheartjsupp/suae036.065
Published: 16 May 2024
“ Conclusion
Despite high intensity statin therapy and lower LDL cholesterol targets, a substantial proportion of patients in cardiac rehabilitation still had elevated triglyceride levels. This study highlights the potential role of Icosapent Ethyl in managing hypertriglyceridemia in these patients.”
When it doesn’t make sense, something is brewing. 🙂
Hard to know how many here are as familiar with R-I as some of old-timers. I remember at least me, wanting the events to not happen fast thinking it would indicate success. I was going to mention CARA in my post as I seem to remember some discussion of that stock here a few years ago. Can't remember if it was you or North on that discussion.
As far as interim analyses, I can imagine that if they stopped it at one of those the stock would have zoomed but of course many thought that it would open it up to more skeptics of the study, so management decided to complete the study.
RMB. Well in the near term watch CARA ...trial data due this QT. Wife has used their drug on at least 1 of her dialysis patients . Data will be on a different indication however its a P 2 trial not powered for stat sig ...and Co will almost certainly raise $ if it succeeds.
NP. ( no position , no prediction ) .
By the way ...do U think folks here know that the R-IT trial had 2 interim analysis done ...the first at 2.9 yrs which I think was stat sig
Thanks for posting. I notice that of all the 25 stocks listed, Amarin has the lowest upside projection of 24.5% whereas most of the others are in the hundreds or thousands of percent. Although some of them might come back from the dead, most will not, and I think Amarin is the safest bet of all.
Jasbg, thanks. Love Santana. Abraxas was the first 8-Track tape I purchased around 1970. Carlos has a unique and soulful gift with the guitar.
Everyone left him alone where we ate . Lot of music people in my town so no big thing .
Actually wandered into Sammy Haggers backyard once ...got off trail , hiking .
Helped a friend do some repair work on a house ...went into the basement and found Jerry Garcia's gold records lying around. Apparently was his girlfriends house at the time
Kiwi
Still playing in Vegas Jas
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Come on Denner ...do your thing
Nissen
Santana goes to out frequently in Summerlin Las Vegas. And he always dressed like Santana. Kind of weird. I would want to eat in peace
Livin in Las Vegas Meet up with me and Jas ...if he's still performing ...and if AMRN gets sold over $5
Santana is great live
Nissen ( can't type Dr Nissen in case I get a cease and desist order ...:--)
Santana came to Montreal in 1982 but alas, I had moved away in 1978, and never got a chance. Would have to say that the most memorable performance I went to was Led Zeppelin in 1970. A couple of years later went to a Sly and The Family Stone concert and it was a disaster. Sly Stone had laryngitis and instead of cancelling the show and refunding us, they went on with it.
Apparently Santana had heart surgery in Dec. 2021. Still alive though.
Jas. actually see if you can find a clip on Santana and Mana ...probably the best live concert I've ever been to
I've posted that I've been buying AMRN under $1
Why buy AMRN ?
Co has EU patent protection out to 2039 . At some pt , one would hope , Denner et al can find a way to meaningfully crack the remaining big 3 EU markets .
That may take ... close your eyes and cover your ears ...some Real World Evidence or small follow up trials because I doubt they will make much headway with their current approach
ANYWAY .....should they finally get it together and get AMRN sold for over $5 ...I'll pay for your flight to Las Vegas to see Santana play if he's still performing .
You'll have to pay for your own Motel 6 room
Your pal. Nissen ...I'm serious about paying for your ( regular economy class ) flight .
Jas. probably the best live show I've ever been to .
Santana used to occasionally hang out at a local restaurant we went to
Your friend ..Dr Nissen ....:--)
Weekend ! We need some 'real' music in our ears to handle the current AMRN value:
DYK 141,700 ischemic stroke deaths occurred in the USA alone (2021)?
@Amarincorp @DLBHATTMD @SABOURETCardio @mmillermd1 @gabrielsteg @VietHeartPA #IPE #EPA #VAZKEPA #VASCEPA DYK there were 141,714 Ischemic Stroke Deaths (2021) in the USA alone? pic.twitter.com/g9uzTBg4z2
— Mike Everts (@GeoWizz_) May 17, 2024
Its difficult for Amarin to sue individual Docs for patent infringement...but pharmacy chains and pharmacy benefit managers(PBM's) and insurance companies are not immune from infringement suits.
Nuke...Docs hate wasting time, writing Rx's...Perhaps it would be a worthwhile trial for Amarin to distribute free Rx pads to Docs...inscribed, among the writings..."Vasepa 1 gram Q.I.D. P.O....along with the letters DAW".
Pharmacies would still ignore the Rx pads' DAW in some cases, but not in all.
At the very least, it would provide Docs with some inexpensive exposure to Vascepa, even if many Docs eventually throw the Rx pads away, as many of them would.
Lem from your lips! Congrats on the new one and similarly with a three and five year old, is exactly why I’m on V and why we should be part of the marketing story to all middle aged men, dads or otherwise. What really chaps my ass about all of this is how safe and effective V is, and how disruptive it will be once in the hands of a capable pharma team to help promote not just CV risk reductions, but for other indications as well. I’ve previously mentioned my skin improvements, too, in having eczema issues my entire life. They’re all but gone now. On the safety note, our we got the beat commercial was just the tip of the marketing iceberg and I recall folks FUD’ing all over the side effects listed during the commercial. Not one of our side effects are as severe as the ones I heard just now on a Jardiance commercial, where for about 20 seconds they rattled off a host of potential side effects that “could result in death” and this one - possible loss of your lower limbs. Absolutely insane.
Or, some insurers have removed V from their formulary and no longer cover brand
You’re spot on. Doctors are prescribing generic because 1) either they’re stupid or 2) insurance companies are pushing back on DAW which is infringing.
We all know the gory details.
Congratulations on your baby girl. My youngest daughter just turned 24. I was 48 when my wife delivered our daughter.
Vascepa works!!!
OK, then it takes more than 18 months.
He will need more than 18 months as slow as this is going. The Germany approval is a year away very best case scenario.
An amended discovery confidentiality order, agreed to by both parties and signed by the magistrate judge in the Trenton antitrust case, should pose no problems. Details not necessary to us, and not available anyway.
Yes, see my previous post about an EPA threshold.
I recall seeing some Dose Response curves for EPA in control arm of REDUCE-IT vs. Placebo (I can't put my finger on it at the moment, but it showed a hazard ratio inflection point at about 100 mg/dl EPA suggesting a threshold near this value in order to show benefit. This may explain why STRENGTH may have missed that threshold. I'll see if I can find that reference.
Capt. Thx. I remember there being a lot of discussion around the optimal serum EPA levels as levels over the 4 gms daily used in R-IT may increase risk .
Theres this concept of therapeutic window .....high enough dose to confer benefit but not high enough to significantly increase risk / ae's
May confer higher risk of bleeding and Afib .
Kiwi
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