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Thanks, raf!
Thank you for the info!
Kiwi,
That's correct.The incidence of recurrent ACS is high within 30-day after MI, but unclear if there is any difference between 3 months and 6 months.
Kiwi,
It is unclear whether JELIS excluded "history of" unstable angina, but I don't see any reason to exclude it in JELIS.
Both trials excluded acute coronary syndrome which includes unstable angina.
The first question is whether icosapent ethyl has anti-inflammatory effects. To my knowledge, the ANCHOR and MARINE studies were the first to suggest anti-inflammatory effects of icosapent ethyl, both of which used mineral oil as a placebo. If mineral oil has proinflammatory effects, then the biomaker results in the ANCHOR and MARINE studies may have been enhanced by the action of mineral oil, raising the question of the anti-inflammatory effects of icosapent ethyl. However, considering the results of the CardioLink-9 trial, some anti-inflammatory effect may be possible. If mineral oil has no proinflammatory effect, it is possible that the REDUCE-IT sample group had elevated inflammatory markers as a natural consequence of their age and comorbidities. The possibility that icosapent ethyl prevented that natural rise cannot be ruled out. In fact, the answer may lie somewhere in between. In other words, icosapent ethyl may have an anti-inflammatory effect, but mineral oil may have a more or less proinflammatory effect.
My personal opinion is that CVOT is what the medical industry cares most about, not anti-inflammatory or cardiovascular risk markers. If these markers were sufficient, the REDUCE-IT trial would not have been necessary and the ANCHOR trial would have been sufficient. We know how much LDL levels increase the risk of cardiovascular disease (about 3% according to the FDA?) but we may not know to what extent elevated levels of other markers are involved in the increased risk of cardiovascular disease.
The results of this study may make people more hesitant to prescribe icosapent ethyl, but I suspect that the impact will not be as strong.
The results of RESPECT-EPA are eagerly awaited, but it is a double-edged sword.
NS,
Part 1: at least 80 studies
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7537802/pdf/suaa117.pdf
Part 2: REDUCE-IT is the research with the greatest impact on the public, and it is a game-changer.
NS,
Thanks PD!
Seems like they may complete the data analysis by this September
Yes, unfortunately
Because Amarin has a vested interest
Funny,
3.6 million is from National Health and Nutrition Examination Surveys (NHANES).
The highlight "An estimated 3.6 million US adults are REDUCE-IT eligible." is misleading.
NS, thank you!
NS, do you have any update on AMRN and Dr.Reddy case? Sorry I have not followed the case recently
NS, I have no idea, but the fact is they could find a supplier sooner than expected
Duke, they said "CCS' major customers have a market share of 10-15% in the end market"
Not customer, but customer"s"
Thank you, Raf!
Based on this info, the current script number makes sense. US market is dead at least for short term.
EPA supply: It seems that Dr. Reddy obtains EPA from somewhere, not from CCSB.
CCSB's main customers: Hikma and Apotex
Thank you for sharing the report!
Agree
Kiwi, I don't think it affects MITIGATE CAD data. Interesting thought though
Kiwi,
Kiwi,
I think we need to wait until this fall for the result. May be AHA (November 5-7, 2022)
Rose,
New Onset of DM
IPE: 3.8%
Placebo: 3.7%
P 1.04
New onset of DM is not primary or even secondary endpoint in R-IT, so it is hard to tell anything based on R-It result unfortunately.
BTW, I don't except any gain on short-to-middle term SP based on this study, or even alzheimer / cancer / NASH, etc, except for MITIGATE. If MITIGATE fails, we may need to wait at least 5 years for tangible benefit, or hope black swan
PD,
We need government funding, like NIH
Statin has risk of DM progression. Combo pill or at least concurrent use of both statin and IPE may be beneficial for both progression / prevention of DM and CVD
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2784799
Will Vascepa prevent DM?
https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(22)00219-5/fulltext
Great review about TG
So you've heard a lot of stuff, you've read a lot, maybe you listened to our podcast @cardionerds on it, and yet something is still missing.
— Richard Ferraro (@RichardAFerraro) April 22, 2022
TRIGLYCERIDES NEED A TWEETORIAL!
Let’s get right into it with 2 big points to start pic.twitter.com/xyGIlQQ4HC
RAF, based on Amarin’s PR, they knew it at least a few weeks prior to ACC
It is interesting that Amarin had already known as of 3/21/22 that MITIGATE will not be presented at ACC.
https://investor.amarincorp.com/news-releases/news-release-details/latest-research-evaluating-vascepar-icosapent-ethyl-be-presented
Kiwi, JIMO,
1) If the results of 6-month follow up were apparently negative (eg, p˜1), I would present the results now.
2) If the results of 6-month follow up were apparently positive (eg, p < 0.05), I would present the results now.
3)If the results of 6-month follow up couldn't say either way, I would cancel the presentation and wait 12-month follow up result.
They just might have not had enough time to analyze the data though.
Or failure of embargo policies...
MITIGATE is not scheduled any more.
https://www.abstractsonline.com/pp8/#!/10461/session/518
Generic in Japan
Would you still use generic?
https://www3-nhk-or-jp.translate.goog/news/html/20220324/k10013549201000.html?_x_tr_sl=ja&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=sc
Kiwi. If you listen carefully to the 14.51 min onwards of the MITIGATE video link below
https://rethinkingclinicaltrials.org/news/june-18-2021-the-mitigate-study-insights-from-a-decentralized-virtual-electronic-health-record-based-pragmatic-clinical-trial-andrew-ambrosy-md-alan-go-md/
he is referring to the 1,244 who have completed the consent forms to be part of this trial on Vascepa at the time the data was pulled, and it was closer to 2,000 on Jun 18, 2021.
Please listen carefully to the video.