Reiterating Dr. James Stein’s Central Point — On SHARP


As I earlier wrote, and Matt Herper has noted, SHARP showed only a very slight outcome benefit from Vytorin®, in renal disease patients.

I want to reiterate, then what James Stein, MD — of the University of Wisconsin’s Cardiology program — told Matt, over the weekend: theoretically speaking, all of the benefit seen in SHARP may be due to the presence of a simple statin, in Vytorin’s combination. So why pay 50 to 100 times the price — when a generic statin may well be the primary active agent?

That will be the question. . . as we wait for IMPROVE-IT. Here, again is Dr. Stein’s pullquote, from the Forbes piece:

. . . .[In other studies,] the relative benefit from Lipitor® was 18%, about what was seen in SHARP. By this argument, Sharp proves that diabetics benefit from a cholesterol-lowering regiment that includes a statin like Zocor®, but not that the Zetia® component did anything. . . .

Indeed. We will wait until 2014, or beyond, for that answer.

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