A.E.s are often under-reported with high doses of potent statins in particular. Additionally, there is no reduction in mortality or increase in the lifespan of one on statin therapy.

Several risk factors should determine if one is placed on statin therapy, and not just one.

Statins do decrease CV events and risks significantly. The meds. increase endothelial function, stabilize coronary plaque build up, and decrease thrombus formation. Maximum reduction in LDL is evaluated after about a month of therapy.

There is evidence to suggest that statins have other benefits besides lowering LDL, such as reducing inflammation (CRP), those with dementia or Parkinson’s disease, and some forms of Cancer and cataracts.

It appears those statins produced by fermentation, such as Zocor and Pravachol, have less myopathy than the other synthetic statins, possibly due to being more hydrophyllic.

Yet overall, the existing cholesterol lowering recommendation should be re-evaluated, as they may be over-exaggerated.

Address diet in children, who have the arteries of one who is middle age thanks to their diets and recommendations of statins for them.

Thanks for the clarification and the links. From the links provided it does appear that AstraZeneca is taking a measured approach. My assumption that AstraZeneca had already filed for FDA approval was based on the statement that “AstraZeneca doesn’t yet have FDA approval…”
We all know what happens when we assume.

Thanks again.

To answer the question, this is also from the Brennan conference:

“From a regulatory perspective we plan to make a submission based on the JUPITER trial sometime in the first half of 2009.

“As with any major new commercial opportunity, we will be able to use 2009 to lay all the appropriate groundwork including consultation with opinion leaders, regulatory agencies and payers. We will also engage with prescribers; specifically to gauge their response to these data in terms of their own practice and attitudes towards prescribing Crestor.”

I would post a link, but I don’t have one, only the text of his remarks.

Hope this helps,
ed

“UNDER-promise, then OVER-deliver” as to EPS.

Consider that Schering CEO Hassan has tried to make a career doing the opposite — he has consistently “over-promised, then UNDER-delivered. . . .”

And lately, he’s been willing to blame EVERY UNCONTROLLABLE factor, from currency swings, to an “mean” FDA, to a not-yet-here, but coming Obama Administration. . . .

And yet, he never looks into the mirror — and REALLY sees himself.

Sees that he is the mirror opposite of AZ, now.

So — yeah — I’ll take the AZ “under-promising” with a BIG smile. Good to “see” ya’ out, and about!

Cheers!