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Kiwi, if event rate of COVID-19 gets higher, the results of MITIGATE trial must be interesting. Even if it's low, secondary outcomes including cardiovascular disease event are interesting. Only concern is short term follow-up. MITIGATE has only 1 year follow up compared to 5 year follow up in REDUCE-IT.
Kiwi, thanks!
Kiwi,
Kiwi, do you happen to know the vaccination rate in Kaiser members?
Kiwi,
Kiwi, thank you for sharing the website. Only 1% event rate of moderate-to-severe COVID19 is concerning given that they need 10% event rate to have enough statistical power.
Kiwi,
Kiwi, I am not sure what I disagreed with you.
Both will definitely assess the effect of Vascepa on severity of COVID which I am looking forward to see. However, number of COVID patients will be likely different between those studies.
The number of COVID-19 patients in treatment arm:
PREPARE-IT part 2: about 1,000
MITIGATE: considering P-IT 1 result, maybe between 150-500?
If majority of participants in MITIGATE develop COVID-19, the data must be really interesting.
Kiwi,
Yes, definitely. They ignored Jelis, but can't ignore RESPECT because of REDUCE-IT.
Kiwi, considering each study design and outcomes, the chance of success is:
PREPARE IT part 2 > MITIGATE > PREPARE IT part 1
MITIGATE is to prevent COVID like PREPARE IT part 1, not treat, but the choice of patient population is better than PREPARE IT part 1.
Oh, I see.
Severe (S) Acute (A) Respiratory (R) Syndrome (S) coronavirus 2 = SARS-CoV-2
Not severe Acute (A) Respiratory (R) Syndrome (S) coronavirus 2 = severe ARS-CoV-2, right?
Cardiolink-9 included MILD Severe (S) Acute (A) Respiratory (R) Syndrome (S) coronavirus2 = mild SARS-CoV2
Rose, we need more scientific evidence of EPA. To be fair, current evidence level of EPA is much lower than statin. I don't think there is any short term catalyst to increase script except for COVID trials.
Possible catalysts for CVD, which only have long-term effect on script:
- RESPECT-EPA trial (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051): we will see the result likely next year
- secondary outcome of MITIGATE trial
- strong evidence of association between CVD and EPA level
Without more scientific evidence of EPA benefit, we can't get strong recommendation from national guidelines such as ACC which mainly affects physicians' decision.
Kiwi, wrong. Why did you add "severe"?
Cardiolink-9 inclusion criteria:
Inclusion criteria: outpatients who have received a positive local SARS-CoV-2 test result within the preceding 72 hours and at least one of the following symptoms: fever, cough, sore throat, shortness of breath, myalgia.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8388138/pdf/main.pdf
Kiwi, I hope the current rate won't continue and the rate will increase.
PD,
Sleven, 300 mt in total
PD,
CCSB news:
the new EPA plant is planned to be put into operation in the first quarter of next year,,,,,,
Fish oil EPA will focus on the U.S. market first, with an original market of about 300 metric tons. Since the patent lawsuit of PIV was challenged by a famous pharmaceutical customer, the appeal of the original factory was rejected. In anticipation of the success of the challenge, the orders of the two major customers have increased greatly, and new customers have also approached us, and the production line of 50 metric tons this year is nearly full and is being shipped.
https://tw.stock.yahoo.com/news/??-???-1762-???????-?????????-091738145.html
PD, to be fair, I would say the control arm of MITIGATE trial does not have to be on V at this moment. Evidence level of V is not as high as statin, which is why recommendation level in ESC is grade 2b and ACC guidelines said "may" use V. In addition, inclusion criteria of MIGITATE trial does not include LDL level, statin use, or TG level.
This is Dr. Bhatt's explanation.
Kiwi, it is hard to tell if higher hsCRP in placebo group is because of normal trajectory curve (age: 10% of increase in hsCRP is expected as population ages 5 years), variability, higher incidence of cardiovascular disease in placebo group (heart attack can increase CRP level), placebo (mineral oil) effect, or combination.
Raf, Dr. Doi knows that beneficial effects of EPA, such as effect on blood pressure, platelet activation, oxidative stress, inflammation, endothelial function, plaque phenotype, or etc, may explain REDUCE-IT result. I think his assessment is fair. AF and Nissen are significantly biased.
Don't worry about it. If AF read the article and concluded that mineral oil was bad, he is not qualified to comment or assess any scientific data/article. Just ignore
PD,
PD, that's a good point. I agree that analysis may take longer than part 1.
I now see PREPARE-IT part1 as if it was phase 1 because it demonstrated the safety of high dose EPA in acute setting. If Vascepa can show acute benefit in patients with any disease (MI, stroke, COVID, etc), it is huge.
marzan,
Everybody, please understand the difference between COVID19 and SARS-CoV2 PCR positivity.
COVID19 = infection due to SARS-CoV2
SARS-CoV2 PCR positive = detection of genetic material of SARS-CoV2 in upper respiratory airway
SARS-CoV2 PCR positive does not mean COVID19.
PREPARE-IT part 1 wanted to prevent SARS-CoV2 PCR positivity (detection of genetic material of SARS-CoV2 in upper respiratory airway)
How can any medication prevent the ENTRANCE of virus to upper airway? Mask and face shield may.
If the test result of part 2 is robust and indisputable, we may see the top line result on 30th.
From my understanding, part1 did not finish its recruitment around May 20th, but finished by June 1. It has 60 day follow-up, so data collection probably finished by the end of July. And then they finished main data analysis by August 28th.
In terms of part 2, its recruitment was completed at the beginning of July (could be June). It has only 28-day follow-up, so data collection likely finished at the beginning of August. The data of part 1 could be analyzed for 2-3 weeks, so as part 2.
Don't be disappointed too much. PREPARE-IT part 1 result is expected. Even vaccine (Moderna or Pfizer) can NOT prevent SARS-CoV2 positivity, how can any medication prevent it?
Let's hope for the good result of PREPARE-IT part 2.
Results from PREPARE-IT 1 found use of icosapent ethyl (8 grams for the first three days/4 grams from day 4-60) in patients at high-risk for SARS-CoV-2 did not reduce the infection rate and there were no significant differences between icosapent ethyl and placebo in adverse events, including atrial fibrillation and bleeding. Investigators noted this is the first large, randomized, blinded trial to "demonstrate excellent safety and tolerability of an 8 gram per day loading dose of icosapent ethyl, opening up the potential for acute use in randomized trials of MI, ACS, stroke, and revascularization." The PREPARE-IT 2 trial currently underway is examining icosapent ethyl in SARS-CoV-2 positive non-hospitalized patients.
2 am on 8/29
It is now, but it has been the same time frame. I guess it will start at 8 pm today (Hawaii time).
They submitted the abstract of PREPARE-IT part 1 in April before knowing the result.
FLUVOXAMINE study: the result is not good
https://www.medrxiv.org/content/10.1101/2021.08.19.21262323v1.full.pdf
I hope PREPARE-IT is better than this.
PD,
Raf,
From their article,