Replies to post #224027 on Amarin Corp Plc (AMRN)

[rafunrafun]

A - so your logic for a 'no primary prevention' vote is because the primary prevention subgroup did not show statistical significance?

If so, do you realize that the trial was not designed (powered) to show statistical significance for this subgroup?

It's like saying that RRR for >65 year olds was only 13%, therefore the label should not include anyone who is older than 65.

[Whalatane]

Morning Atom ...Haven't read all your posts yet but just a few comments .

1) I agree with VuBru's expectation of the label ...ie to reflect the R-IT inclusion criteria
2) I think the primary prevention diabetics ...and ONLY this group of primary prevention patients ...will be included based on a very persuasive presentation by Dr Bhatt.
3) Your posts on Zetia ..you cite the Vytorin Crl .
When you look at the increased risks associated with this combo ( simvastatin with ezetimibe )..you can understand the Crl when RRR was only 6%

I'm on both Zetia and a Statin ( as well as Repatha and Vascepa ) ...and when I started the Zetia with the max dose statin I had to have blood tests every 3-4 mths to chk for elevated liver enzymes ( liver damage ) ....so I was not to keen on taking the Statin and Zetia together but in my case ...stubbornly high LDL cholesterol ...my Cardiologist felt benefit outweighed risk .

Vascepa does not have these risks. The key one my Cardiologists focused on was risk of Afib and wanted to chk his patients for any history of that. The slight increase in bleeding risk ...just discontinue the low dose aspirin most of us CAD patients were on anyway.

So for the primary diabetic population ..at 12% RRR ...benefits still far out weigh risks and IMHO will be included ...altho I expect it to be debated .
JMO
Kiwi