Replies to post #31239 on Amarin Corp Plc (AMRN)

[ggwpq]

JL, seems like the greatest risk to R-I trial is if the actual event rate were much less than 5.2%. Hence, it will take a long time to hit 967 events especially if Vascepa is super efficacious. Just wondering anybody can point to any research that justify the 5.2% event rate. TIA.

[HDGabor]

JL,

Please check / comment this:

We - including myself - used the 5,2% as the event rate of placebo arm, however I could find it only as the overall event rate for the study (ie.: Amarin Presentations for the October 16, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee page 73). If this is the case, then the planned placebo rate is 5,62% and the Vascepa arm is 4,78% (avg. 5,2% with 15% eff.).

The lower than expected total events rate (resulted in design modification in May 2013) due to:
a.) lower event rate in placebo: assuming that “number is calculated by actuaries and takes into account whether they are primary or secondary interventions” it’s not the case
b.) Vascepa is significantly better than 15%.

We don’t know the exact difference, however if the actual rate was (before May 2013, for the total trial and assuming that placebo arm was 5,62% as planned)
5,00% (96% of 5,2%) = 22% eff.
4,94% (95% of 5,2%) = 24% eff.
4,68% (90% of 5,2%) = 34% eff.

[Whalatane]

JL

As some one with multiple risk factors I am fortunate to be able to exchange views with some one as well informed as you

In the past I had to donate 6 vials of blood for research in exchange for 10-15 minutes of face time with a noted peer reviewed UCSF scientist /Cardiologist --Ihub messaging is a LOT easier : )

I acknowledge that 4gms of EPA lowers risk of CV events , especially for those with high TG /low HDL , prior coronary intervention , prior MI etc

If the mean LDL level was 130 in RI as it was in Jelis SIG ( after statin treatment ) then I think you can say "double the cohort and double the risk " ..but since the mean LDL level in RI is likely to be 30% less I don't think it holds ...UNLESS ...you believe that lowering LDL from 130 to say 90 ( and one would also assume a further lowering of HsCRP ) in such a high risk group has no benefit.

JMO ...always happy to read yours ...learn something every time

Kiwi