ferretmoney - V has numerous modes of action, and we don't know the details about how much of the benefit comes from the various modes. Benefit varies pretty widely also based on type of event and the subject. High trig low HDL gets much more benefit (38% RRR vs 25% overall). CV death is reduced less than heart attacks. So, if anything is changed, we don't know exactly what the benefit will be.
But, it's pretty clear there are modes of action that are largely independent of the statin, probably most of them. If RRR or ARR were plotted vs statin dose, and that curve were extrapolated outside the range spanned by RI subjects, it seems very likely to me substantial benefit would be clearly indicated for statin dose of 0. Ditto for trig levels outside the RI range (say down to 100 or lower). It's not the same as proof by a trial, but people with flexible minds and common sense who care about preventing human suffering and death should support extending V to the wide range of people who seem certain to benefit substantially. Trials take many years, and unclear to me how more big ones would be funded given Amarin's tribulations and generic coming in 2029. I think either of the populations you mentioned would benefit. I suppose whichever is larger is more likely to get included in a trial in sufficient numbers for conclusive results.
I'm not counting on FDA making the well-being of Americans their top priority, but we can hope, and thank goodness they have not yet succeeded in their attempt to further tighten their grip by ending off-label prescription.
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