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Whalatane

03/06/22 12:36 PM

#372368 RE: Pharmacydude #372365

Pdude. re your comment

they “don’t believe in preventative cardiology” according to Bhatt,



Please provide a link to that comment to verify .
Both poster JF and myself are Kaiser CAD patients ...He is obviously prior event having had an MI and I'm considered secondary prevention having had a cardiac Cath to determine coronary stenosis ( not enough to require stents ) .

Kaiser prescribes brand Vascepa to both of us

The above is the approach I think the UK/EU will go with reimbursement

Kaiser probably doesn't cover for primary prevention ...but remember most in R-IT were secondary prevention / prior event patients ( from memory ) .

The data April 3rd will be top line data for the Covid portion of this trial ....not interim
The only interim data presented ..if any ...may be for the CAD portion ...ie is the median 1 yr data on over 1,000 patients tracking the 1 yr data on prior event patients in R-IT

Why do U have this idea that April 3 data is Interim data ?

Kiwi
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Whalatane

03/06/22 1:35 PM

#372373 RE: Pharmacydude #372365

Pdude. in response to some of your comments

U dont trust Kaiser because all their controls should be on Vascepa ?

R-IT results are based on patients with LDL below 100 mg/dl on optimal statin therapy with TG's still over 150 mg/dl . Do U know how many in the MITIGATE control fit this profile ? ...or are even on optimal statin therapy ...or even if their LDL is below 100 mg/dl but TG's are still over 150 mg /dl ?
We dont know if the lipid profile in MITIGATE is anywhere close to the lipid profile of those in R-IT .

How many contracted Covid ?
Omicron ravaged the MITIGATE recruiting areas of Nth Ca. At one pt 1 in every 4 tests came back positive for Covid .
MITIGATE is the best trial we are likely to see to determine if Vascepa reduces the hospitalization rate or urgent care visits for Covid .
1 in 4 is a very high covid positivity rate and the profile of those in the trial ( unlike the PREPARE-IT trials ) are those we know with high rates of hospitalization ...ie elderly with comorbities .
Most in MITIGATE will be over 70 , prior event ( stented , stroke etc ) and many are likely to be diabetic and have high blood pressure .
This is a high risk population

P values ... read the design and rational of MITIGATE linked previously

Interim only ... They discuss in the video I linked why they would probably not run an interim. MITIGATE is complete . They will present Top Line data as a Late Breaker at ACC on April 3rd
At least thats my understanding so correct if necessary

Kiwi