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Whalatane

07/26/14 5:26 PM

#31192 RE: HDGabor #31191

Thanks HD
Yes I remember now ...design is for 5.2% ..interim analysis at 912 ? events ..expected by early 2015 ? Is that correct .

Yes unblinded event total were presented at adcom I think .

If you have time , I'd be interested in your calcs for 20% efficacy vs placebo ...how many events would that be and when .

I enjoy reading your posts ..always interesting and challenging

Kiwi
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Whalatane

07/26/14 5:28 PM

#31193 RE: HDGabor #31191

Sorry HD
meant interim analysis expected in early 2016 ...912 ? events triggers analysis

Kiwi
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jessellivermore

07/26/14 7:36 PM

#31198 RE: HDGabor #31191

HD...

"It's an assumption, the design is for 5,2%: "I decreased from 5,2% since the March 13 modification - TG min. 200, instead of 150 - based on lower than expected events"

Actually raising the trig level from 150 to 200 should increase the event rate in the control...So the risk correction might be closer to 5.4% in the control group...This would help speed up the trials.

":>) JL
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BioChica

07/27/14 8:21 AM

#31205 RE: HDGabor #31191

Certainly should increase the rate of events. Triglycerides and the number of sdLDL particles are linked. This paragraph includes eastern/western population risk factors, related to sdLDL.

Lipoproteins play a pivotal role in atherogenesis. Low
Density Lipoproteins-Cholesterol (LDL-C) is a major tar-
get in the guidelines for the prevention of CHD. However,
plasma LDL-C levels are insufficient to identify individu-
als with incidence of CHD events, because approximately
50% of all CHD events occur in persons with normal or
even low LDL-C concentrations [5]. LDL is composed of
heterogeneous particles differing in density, size and
chemical composition. It is reported that people with pre-
dominance of small, dense LDL (sdLDL) have a 3-fold
increased risk of CHD.
Recently, sdLDL has been high-
lighted as a new potent risk marker for CHD in Westerners
and also in Japanese populations, which has relatively
lower LDL-C levels [6].