Saturday, November 24, 2018 1:54:52 PM
Like perhaps many here, I searched for trials where statins were co-administered with mineral oil and lipid outcome data were presented.
There was a trial, an A&WC trial, that indeed did this. Amarin's MARINE trial included patients both on and off statins. Of course, the control arm was given mineral oil (one of the treatment arms as well as it turns out).
So one of the main critics of the R-IT Trial is Dr. Steve Nissen. It is important to know that he is the PI of a competing Omega-3 trial using Astrazeneca's drug Epanova. We would hope that physicians are above the politics of drug development and put patients first. That does not seem to be the case here.
In a recent Youtube video he says regarding R-IT:
Source: AHA 2018: Highlights with Dr. Steven Nissen
Well, he has yet to come forward with this "considerable data".
I was compelled to do some digging.
As it turns out, many trials report similar changes in lipid parameters.
Ironically, I found one where Nissen was the Author and the placebo arm experienced a 7.6% increase in LDL-c and a 64% increase in hsCRP.
Strangely enough, Nissen's paper makes no accusation that the placebo he used in his trial harmed patients.
I get that there are both commercial and scientific aspects to this. I am an investor in Amarin and acknowledge my bias. It's too bad we can't expect the same from this physician working for Astrazeneca. I do wish them luck in their trial though. With all that DHA in Epanova they are going to need it.
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