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Re: Atom0aks post# 223943

Saturday, 11/09/2019 6:19:58 PM

Saturday, November 09, 2019 6:19:58 PM

Post# of 426436
Atom

re
It is an "or." REDUCE-IT (hyperlink) had two populations,

1. 29.3% on the basis of primary prevention (i.e., patients had diabetes mellitus and at least one additional risk factor)
2. 70.7% were enrolled on the basis of secondary prevention (i.e., patients had established cardiovascular disease)

The secondary prevention showed greater benefit than the primary prevention population (27% vs 12% RRR, hyperlink). Therefore, you can't expect the FDA to lump them together under the same label.....my emphasis .

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Say what ?....Both groups had significant RRR ..yes one more than the other but you really expect the FDA to say to the primary prevention diabetics ...no no ...not for you ..12% RRR is not good enough ?

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