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HDGabor

10/04/15 6:34 PM

#60608 RE: Whalatane #60607

Kiwi-

I am trying to make a pt about those who sign up for CAD clinical trials ...or spend their time on CAD themed message boards.
It helps us ( CAD patients ) stick to the meds , life style /diet changes etc that we know we must do.

I understood, what you would like to suggest, but it is not a new trend / info. It was exist at the time of the design of the study, we could assume it was built in the expected event rate.

IMHO they should have only recruited diabetics and pre diabetics with prior CAD intervention. You have about 3,000 patients in the trial with TG's between 150-200.

The mix of the patients is as was designed. If they have only diabetics and pre diabetics with prior CAD intervention in the trial the expected placebo rate could be higher than 5.2(5.9)%. We (and Amarin) do not know the exact profile of the patients, but ie. ANCHOR had app. 70%+ diabetics and R-IT "Mean and median baseline TGs >200 mg/dL and ~1/2 of patients expected to also have low HDL-C". JELIS 3,664 subgroup had a median TG 160-163 and meanwhile the eff% was significant the TG reduction (so the level of the TG) was small / "irrelevant".

Best,
G