In fairness, Larry Husten of CardioBrief flagged it, as part of a much longer article of his -- but I amplified it -- and ran it as my Arbiter 6 story lede, on Sunday night.
Now Forbes is fully on to it, thus:
. . . .Many researchers worry the study [IMPROVE-IT] could take years longer than this. In an editorial published in the New England Journal of Medicine Monday, John Kastelein of Utrecht Medical Center in the Netherlands wrote that it was "uncertain whether the trial will ever reach completion". . . .
Some say even 18,000 patients may not be enough to settle the question. Rory Collins, an Oxford University researcher who believes Zetia does prevent heart attacks, says there is a chance the study will give a false answer that there is not a difference. Heart attack rates in the study may be so low that it will be difficult to prove any difference between drug regimens. . . .
Indeed.
1 comment:
Mark these words: IMPROVE-IT will be at the very best a neutral study - thus it will show no difference at all between Vytorin and generic simvastatin. Given the number of events recorded to date (~2300) in 15,000 pts enrolled and with enrollment having started in 10/2005, they actually should have enough statistical power to detect a clinically meaningful difference in events. The problem is, they haven't, and this is mainly due to two main false assumptions by Merck: all LDL-C lowering is NOT equal in terms of its association with event reduction, and their assumed relationship between LDL-C reduction and CV event risk is not what they think it is. On the latter point, Merck believes that for every 1.6 mg/dL decrease in LDL-C, CV event risk is reduced by a relative 1%. What they are too blind to see is that this relationship does not hold true at the LDL-C values expected in this study (baseline ~100 mg/dL, and on-Rx values in the 50-65 range. In fact, this relationship is actually curvilinear, and the CV event reduction gets progressively smaller and smaller as LDL-C declines below 100. The "joke" will be on them. It would be funny if it weren't for the 10's of millions of patients that will get Zetia/Vytorin instead of a more beneficial therapy (niacin, anyone?) at a combined cost of $4+ billion/year until we find that out.
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