RVX
Rosu and Ator won't get IVUs reductions in six months of dosing.
Cleveland Clinic designed this trial, not RVX. Worth keeping in mind. The primary is change from baseline, but there is a control arm to compare the changes in baseline. Recall the ETC-216 data didn't report a 4% difference from baseline in ETC-216. It reported a 4% difference between the growth in the placebo arm and the reduction in the control arm.
Last we talked on the subject, RVX management said they'd report the numbers both ways to reduce confusion.
As to your criticisms of the 2004 Asztalos paper and preference for the 1989 Gordon paper, there are a couple of things you should understand.
Gordon looked at overal HDL-C and not sub-fractions. The Gordon paper comes to the virtually the same conclusion as the later Asztalos paper -- every 1% rise in HDL-C creates a 2-3% decrease in CHD.
The Asztalos paper differs primarily in that his team looked specifically at sub-fractions. They concluded a 1% increase in a1-HDL generated a 26% decrease in CHD. This was supported internally by a1-HDL to HDL-C ratios having an even higher benefit -- which, to some extent, addresses the point that HDL-C measured by weight (which isn't how they measure it in modern studies) is largely a1-HDL.
As to the superiority/inferiority of the statistical methods, I won't argue there. Since the Gordon paper doesn't address a1-HDL at all, it's rather unfair to ding Resverlogix management for not using a1-HDL numbers from that paper. Again, note that overall HDL-C projections were essentially equivalent between both papers.
David
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