"One item that I never fully understood is why RVX put plaque regression as a primary end point in the ASSURE trials....still, why not specify.......HDL increases as primary end points?"

If you haven't already, you should read "The Blunt Bean Counter: Resverlogix- A Cautionary Tale." The SUSTAIN trial (HDL-cholesterol increase as primary endpoint) and ASSURE trial (plaque reduction as primary endpoint) more or less ran at the same time. From what I read in the Blunt Bean Counter article, ASSURE was supposed to start earlier, but was delayed. So with SUSTAIN, Resverlogix already had a HDL-cholesterol endpoint centered trial ongoing while ASSURE was also ongoing. As you can read in the article, the previous ASSERT wasn't exactly met with cheers of success. Add on to that misfortune the CETP inhibitor drug failures during this time period, which created a somewhat negative viewpoint on the HDL-cholesterol hypothesis. In my opinion, there is no way that a drug would be FDA or EMA approved for raising apo-AI or HDL-cholesterol without some kind of other clinical trial readout supporting cardiovascular benefit, such as plaque reduction or MACE reduction. Not because I personally don't believe in the HDL hypothesis, but because the burden of proof is still there for any HDL modulating therapy to show a therapuetic benefit, such as MACE reduction. Perhaps Resverlogix in ASSURE was trying to thread the needle between doing a long, expensive cardiovascular outcomes trial for MACE reduction and proving some kind of meaningful benefit in a shorter, smaller plaque reduction trial as a surrogate for MACE reduction. C'est la vie. What's done is done.

BearDownAZ