Replies to post #169378 on Amarin Corp Plc (AMRN)

[IgnoranceIsBliss]

That is an accurate statement -- I just double-checked the NEJM article, but knew that already

The primary prevention cohort -- which was ~30% of enrollees and provided 309 primary events (about 19% of total events) had an HR of .88 and was not stat sig. It was one of the few major subgroups not stat sig.

Another was women, who were only 340 of the total primary events and were just barely non-stat-sig (HR was .82, top of confidence interval on HR was 1.01). That's an RRR of 18%, which is clearly clinically meaningful. There just weren't that many women in the trial (about 29% of the total).

These things are hardly a big deal. Biased detractors harp on these things, but scour any other major trial -- even rather successful ones -- and you'll find similar things.

The trial wasn't powered to have every imaginable subgroup stat sig.

If the label for someone reason only extended to men with trigs > 150 and prior CAD of some sort, that is still a zillion people.

[sts66]

Yeah, primary prevention (PP) was a failure, and I was really, really disappointed by that result - personally, because I'm taking V with hopes it prevents a CVE (stroke scares me the worst), and as a statin hater, I was looking forward to V being able to claim it's the only drug proven to prevent the first event. Whether that limits peak sales or not I have no idea - we've seen pro-V docs say they are or will take V for their own health despite them not having suffered a CVE yet, so we could see significant off label uses for PP. Which makes me wonder what will actually be on the R-IT label - will it include all at-risk patients, or just ones with established CVD?