A close-follower of all things cholesterol management, Marilyn Mann (see her blog there), pointed out in my comment section that I missed an important sub-story this week, on the FDA-sanctioned label changes occasioned by the SHARP study. Whitehouse Station reported it as a net-positive, which I still think it is -- but there was no new indication for kidney disease sufferers. Here -- let's have Marilyn explain:
Marilyn Mann said. . . .
. . . .I was surprised that you didn't blog on the FDA's decision to turn down Merck's request for a new chronic kidney disease indication for Vytorin and for Zetia when prescribed with simvastatin.
The FDA did permit a revision to the Vytorin label (on pp. 27-28 of the label -- a large PDF file) that states the results of the SHARP trial, but without an indication, Merck won't be able to advertise the use of Vytorin for reducing the risk of cardiac events in CKD.
January 28, 2012 9:35 PM. . . .
Great point! My older background on the SHARP label application matters may be found here.
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