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amarininvestor

05/29/16 12:32 PM

#81501 RE: Whalatane #81498

That sounds logical on the surface. However I believe it misses to explain the paradox of why the expected CVD rate in reduce-it is expected to be about 4 times higher than in Jellis.

It can hardly be explained by LDL levels only I think.
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BioChica

05/29/16 5:40 PM

#81506 RE: Whalatane #81498

Yes and what are the long term negative effects?
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HDGabor

05/29/16 7:13 PM

#81509 RE: Whalatane #81498

K-

I don't think you will see the same degree of separation in the arms when EPA is added to what is to me a lower risk group (due to intense statin therapy)

As I asked earlier, please use event rate / arm (also). What is your expected rate for R-IT's placebo and V arms?

Please consider the following, before answer:

1.) placebo arm

- Amarin estimation / guess was higher than 5.9%. THe pre-SPA design was with 6,990 patients and - more likely - it contains protection already against the possibility that the actual placebo event rate is lower than the estimation / guess. Do not be confused by the affordable 5.2% (min. acc. to final design), it is the result of the additional 1,000 patients, but it does not affect the original estimation / guess (5.9%+) it gives more protection.

- The over 20,000 patient years and 967 events means a composite rate of 4.84%. The placebo rate could not be lower than this (unless you would like to convince anybody that V rate is higher than p rate ...) and it is the rate if RRR=0%.

2.) V arm

- JELIS had (vs R-IT) higher LDL (178 vs below 100), patients received 10 mg of pravastatin or 5 mg of simvastatin once daily vs. R-IT patients could receive stronger statin, TG was lower (163 vs mid 200). We do not know the hsCRP data but if it was higher than in R-IT it was resulted in higher event rate (than at the same level). The AA/EPA was more or less the same (1.67 at baseline) as in ANCHOR (1.61) at week 12. Furthermore, the majority of the event was angina, which could be "overreported" (I mean more events were reported, event rate was higher).
Based on these we could assume that V (R-IT active) rate will be lower than JELIS placebo rates were.

- JELIS placebo rates were:
> MI: 4.37%
> prior coronary intervention (PTCA or CABG): 4.78%
> stable AP: 2.04%
The average (with equal weight) is: 3.73%

So, what is your expected rate for R-IT's V (active) arm?

Best,
G