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I really don’t have an opinion/expectation for MITIGATE. Too many unknowns (still not clear how many Pts in the trial for example) I don’t known how to incorporate the 10:1 control:Pt aspect into real effect on p value, I don’t trust the motives of KP (pretty much all the controls should be on V anyway but they “don’t believe in preventative cardiology” according to Bhatt, unless it’s super cheap generic statin), etc. The biggest question is how many of the “x” active V Pts actually contracted COVID during the limited time they were in the trial????? If 10% (of the original 1,500 planned enrolment) got infected and of those 20% got hospitalized (7% in PI2 with healthier Pts) then you have 300 hospitalizations to generate a p value. If your asking if I think V will show a benefit then the answer is YES. Will the data achieve a p less than 0.05?????? This isn’t final data, merely interim analysis so that lowers the acceptance of any results right there.
I remain convinced that the AA:EPA ratio is the key data to be analyzed when it comes to COVID or CVD or any inflammatory condition. I asked Dr Bhatt about that ratio when I had a chance to talk to him and his response “there isn’t any plan to do that analysis at the moment “ still haunts me. WHY wouldn’t he analyze that data? I only have 2 possibilities 1) he has looked into it and found no correlation 2) he did find a correlation but Amarin won’t allow full analysis/publication because they fear that it won’t be V specific and people will use any EPA containing product to get their EPA levels up. The 3rd option of not having the time/resources isn’t realistic because I’m sure Amarin would pay one of his students to do the data analysis or even have their own SHero do an internal stat analysis (although she doesn’t appear to be very good).
To follow up on yesterday’s post: the evidence is mounting that the underlying problem to many chronic medical conditions (as well as a few acute ones like COVID and sepsis) is our diet being too high in Omega 6’s and too low in Omega3 and RESOLVINg inflammation as an explanation for V’s benefits. My experience has been that doctors like positive data but need to see WHY it works before they truly believe the data. In the short term (2 years) the “resolving inflammation” MOA implies an increased likelihood of positive results in MITIGATE, BRAVE, RESPECT-EPA as well as making the database at insurance companies like KP increasingly likely to being able to provide positive phase 4 data as well as comparisons of similar Pts with and without V in other illnesses like Alz, DM2, autoimmune etc.
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