Sunday, November 15, 2009

CardioBrief's Larry Husten -- Some Bigger Open Questions


The New England Journal of Medicine has published Arbiter 6 -- and it could scarcely be any worse, for Zetia. Niaspan's a clear winner; increased risk of cardiac events in patients taking the Zetia arm. Larry Husten has much more -- do go read all of his, at CardioBrief.

But this bit -- from two former Merck/Schering-Plough joint venture PIs -- may be the most troubling admission I've seen so far, tonight:

. . . .Kastelein and Bots raise the question whether we will ever find out the truth about ezetimibe: In their editorial they write that "the large number of hard clinical end points (>5,000) required to achieve sufficient statistical power in IMPROVE-IT makes it uncertain whether the trial will ever reach completion". . . .

[Dr. Kastelein, my sharper readers will recall, was the PI on ENHANCE; Dr. Bots was brought in later, to evaluate the readability of the CIMT data in ENHANCE, and declared it "fine" -- "no better, or worse, than other similar studies' data", despite Merck/Schering-Plough's insistence that much of the ENHANCE CIMT data was poor.]

So -- IMPROVE-IT (see my left margin count-down clock, still at least 1,506 days to go!) -- May. Never. Reach. Completion.

Well -- if that is remotely close to accurate, "game over", for Vytorin/Zetia. IMPROVE-IT was to be the pair's "last best hope".

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