https://seekingalpha.com/article/4221035-amarins-reduce-tria…
Summary:
AMRN provided an update on the REDUCE-IT trial of Vascepa; the NEJM provided an online article and detailed supplement.
Based on these, I am concerned that the placebo group received an active agent that in effect was an anti-statin, leading to an increase in LDL and CRP levels.
The placebo contained mineral oil, a laxative, and the placebo group had more diarrhea, suggesting the placebo was active; the placebo group also had more anemia.
Thus I posit that it’s possible that the placebo was really a “placebo;” possibly the dramatic 25% reduction in MACE overstated the “true” effect;
Only the FDA will see all the data and opine as to how to update Vascepa’s label.