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Re: Whalatane post# 398592

Wednesday, 01/18/2023 3:33:03 PM

Wednesday, January 18, 2023 3:33:03 PM

Post# of 447466
Kiwi, I honestly can't make heads or tails on the MITIGATE trial and what to expect.

Things that give me pause:
Poster on twitter said she was enrolled, and the trial only lasted one year
On clinical trials.gov the timeframes for each endpoint is 0-12months
Dr. Ambrosy said followup was 6 months min and up to 12 months.

Things that give me hope:
The trial supposedly doesn't end until Feb 28, 2023, implying > 1 year follow up
KM vaguely alludes to "real world evidence" at JPM conf
Clinical trials.gov also states:
"Patients randomly assigned and enrolled into the intervention arm will be asked to take IPE (2 grams by mouth twice daily) for a minimum of 6 months and until study completion"
Lastly, even if we ignore CVD, the trial investigators were noticing low Covid related event rates, so may have been forced to extend followup regardless of intention to capture CVD.

I really do hope Amarin/investigators had the foresight to leverage MITIGATE for CVD. The last thing I want to see is another tweet from Bhatt saying "I asked for a longer trial, but Amarin refused due to budget constraints", similar to the tweet he made after PrepareIT 2.
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