Replies to post #24821 on Amarin Corp Plc (AMRN)

[MontanaState83]

Nuts - I don't normally post here. Yea, your correct about TGs above 500. So, what if my levels are 499, 498, 497 . . . Then all is hunky dory?? The point I'm getting at, is this whole situation is completely F'd up. The American Heart Assoc, among other organizations all recommend TG levels below 200 (actually 150) due to risk of heard disease. Twice, mine were over 200 and my Dr about krapped a brick.

So, who's correct here, the FDA or most every other organization? In fairness to the people, if the FDA is correct, then the guidelines need to be revised as the confusion is unacceptable.

Personally, I side with the AHA and others as logic is totally on their side (if their is any truth at all about the dangers of fats in your blood).

[chas1232123]

“the FDA approved Vascepa for TG >500 because TG's at that level is KNOWN i.e. proven to cause acute pancreatitis (HTGP), period! “

Dr. Hiatt didn’t seem to know that.

From the adcom transcript, page 259:
“DR. HIATT: …It’s hard to imagine an event-driven pancreatitis trial for super-high triglycerides. I kind of smile when you think about that because that’s just by inference that it’s actually going to be good. We don’t know that, really.”

Dr. Hiatt on page 255: “ … is a cardiovascular outcomes trial really part of the program here? The label simply says, this drug lowers triglycerides in people at risk, which literally is true. …
Because literally, this drug does a terrific job lowering triglycerides. It makes the other real lipid fractions look good, pretty much. But there's uncertain clinical benefit, and they actually have a trial launched to
answer that question.”