Amarin Corp Plc (AMRN)

[AVII77]

what are your thoughts on event rate over time in jelis?

I assume you are referring to the secondary prevention cohort here

https://pdfs.semanticscholar.org/9f3d/a936e48ea268addea9b2bdf95e7dc3db636e.pdf

If so, it looks like the rates decrease with time.
Not very pronounced and not entirely consistent. But in general, for patients who havent had an event at year 1, they have a somewhat lower risk of having an event at year 5 (even though they are 5 years older).

If you look at a large population of millions you will see the risk of cardiac events increase as they age.

But, if you look at a discrete trial population of 8000, you might see the overall risk decrease with time because those most likely (let's say "destined") to have an event are also most likely to have an event early. At the end of the trial you are left with the survivors who, though older, are perhaps slightly more healthy.

I dunno, perhaps I'm not thinking about this right.

But right now In R-IT we have already had 1200 patients experience a first event. It seems likely those 1200 patients were the slightly "sicker" portion of the trial population. The remaining patients would therefore be slightly healthier than the entire cohort. Older now yes. But healthy enough to have not evented yet.

I guess I should acknowledge the change in trigs from 150 to 200 later in the enrollment. I agree that might increase the event rate with time. Similarly, I wouldn't be surprised to find the very slow enrollment at the end was because they stopped taking people in Risk Category 2 (no established CVD) and only enrolled the (harder to find) established CVD patients. And of course, they would be "sicker". A higher proportion of them at the tail end of enrollment might also increase the event rate at a later time.

There are two CV risk categories:

CV Risk Category 1 : patients with established CVD defined in the inclusion criteria. Patients with diabetes and established CVD are included in this category.

CV Risk Category 2: patients with diabetes and at least one additional risk factor for CVD, but no established CVD.

Approximately 70% of randomized patients will be in the CV Risk Category 1 and approximately 30% of randomized patients will be in the CV Risk Category 2.

Enrollment with patients of a CV risk category will be stopped when the planned number of patients in that risk category is reached.