After reading various people's stories here about how their LDL-C levels changed rather dramatically when they cycled off their statin (like +50%), then restarted with or without V, I seriously doubt R-IT patients had anything close to a 10% dropout rate for statins, else the end of trial LDL-C levels would have gone up way higher than they did compared to baseline. I also think Bhatt would have tried to defend the small rise in LDL-C in the placebo group "was due to MO affecting statin absorption" argument using the info if he had it and there was a significant # of patients who stopped their statin, but the fact that he didn't implies that was not considered to be the reason - "reversion to the mean" doesn't refer to "patients stopped being statin compliant" - I believe in this case it meant "patients got lax in their dietary restrictions over time". IOW, they were on their best behavior in order to be eligible for the trial, but once they were accepted and randomized, officially part of the trial, they loosened up a bit on their diet and exercise regimens.
As far as AMRN getting "adjunct to statin therapy" removed from the label, forget about it, not gonna happen - and there's a wealth of evidence that the statin is needed to make EPA's efficacy as high as it was - see Dr. Mason's work. But I totally agree that many docs like you will gladly prescribe V off label to statin intolerant patients, and furthermore, I don't believe insurers will require proof that a patient is on a statin to authorize their V scrip. Even w/o R-IT approval, there's a large number of people on this board who are taking V off label and w/o a statin - whether we'll have similar CV benefits that R-IT patients saw remains to be seen - I think absent a statin V will at least provide us with decent protection from strokes, an opinion influenced by seeing what V did to some of my stroke-risk biomarkers.
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