RE:RE:RE:The Time is Ripe for RVX"
What would the results have been if the Placebo Group was not given Mineral water, Got to wonder if the results would have been lower for the RRR% in the trial." There's little doubt, if any, that Vascepa truly elicited remarkable MACE reducing effects in REDUCE-IT. However, as you pointed out there is some question as to whether the choice of placebo (mineral oil by the way, not mineral water) had
some degree of deleterious effect in the placebo group. I've expressed my opinion on this numerous times. Mineral oil was a horrible choice. But that ship has sailed. We may never know the full truth as to how Vascepa would have performed in REDUCE-IT when compared to some form of a natural, absorbable vegetable oil instead of mineral oil. For example, Astrazeneca is running a similarly designed
STRENGTH trial using corn oil placebo. Corn oil, soybean oil, or some other vegetable oil could have been processed in a way to remove color/taste so as to match Vascepa, or conversely color added to the Vascepa to match placebo. Why Amarin chose differently is mind boggling to me. A horrible decision by the REDUCE-IT clinical steering committe and FDA. With this confound, we may never know for sure how much, if at all, the trial results were padded by mineral oil in the placebo group. So the take home messages are, in my opinion: 1) mineral oil was a horrible choice as placebo and likely increased the placebo group MACE risk a little bit; and 2) Vascepa elicited tremendous benefit in the Vascepa group regardless of the results being partially padded by mineral oil comparator.
BearDownAZ