Atom. best we come back to this in the morning when those on EST can participate if they wish .
Some basic definitions
Primary Prevention .....Primary prevention includes those measures that prevent the onset of illness before the disease process begins.//my emphasis .
So if you have a family history of heart disease and your lipid panel (blood test ) comes back with a high LDL cholesterol reading ...say 180mg/dl ...you are prescribed a statin to lower your LDL cholesterol to delay / prevent the onset of coronary artery disease ( CAD ) plus better diet , more exercise , no smoking etc
If you can't tolerate the statin or can't hit a target of say LDL under 100 mg/dl you are prescribed Ezetimibe as well ( or instead ) ....the aim is to lower your LDL ...no one takes it to lower Tg's.
So if the FDA wanted to target all in the category of primary prevention they would target all those prescribed statins ( since that is the first line drug to prevent onset of CAD and R-IT was run with statins in both arms ) .. and not just the T2 diabetics that were considered primary prevention in R-IT .
The only ( or most of ) the primary prevention patients in the trial were primary prevention diabetics ( as far as I know ) ...thus I expect only the primary prevention diabetics with 1 extra risk factor etc ...to be on the label .......NOT everyone technically considered a primary prevention patient.
I have yet to understand why you think the FDA will not include the diabetic primary prevention group with 12% RRR when they approved Ezetimibe with only a 6% RRR .
Both R-IT and Improve-it ( Ezetimibe ) were Outcome trials
Will chk in with U tomorrow
Kiwi
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