RE: RE: RE: BearDownAZ question 4 u "does higher natural hdl levels remove plaque? is there any benefit to pfizer having a product that both lowers ldl and raises hdl even if the higher levels do not show a significant decrease in plaque buildup?"
-->Yes. Higher HDL levels are associated to decreased mortality. The Framingham Heart Study is a great reference for this.
https://www.ncbi.nlm.nih.gov/pubmed/3196218
That is why a drug like RVX-208 would be so novel. It would be the first drug to increase the synthesis of new apoAI and form new HDL particles, and ASSURE results pending, decrease plaque formation.
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Yes, the SATURN study showed that after 2 years high dose statin treatment, that there was a ~1% reduction in percent atheroma volume. However, not all patients can tolerate high statins. Not all patients need to lower LDL. There may be patients with low to acceptable LDL, but below desirable HDL. There is currently no treatment for low HDL that has been proven to reduce plaque volume. That is what we are hoping RVX-208 will provide. And not knowing what RVX-208 can do in 6-months, it is impossible to know what RVX-208 can do in 2 years like statins did in the SATURN study.
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LDL and HDL are two different animals. Statins have really been the only solid treatment for altering plasma lipoprotein levels, and this almost exclusively affects LDL. Any HDL-cholesterol raising effects of statins may be via a CETP-like effect of lowering levels of triglyceride-rich LDL precursors called VLDL. But statins have NEVER been shown to result in the synthesis of more apoAI or formation of new HDL particles. Any effect of statins on HDL-cholesterol would simply be due to a slower rate of turnover. But this does not mean that these are functional HDL molecules.
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And I reiterate once again. 0.6% doesn't matter. Re-read my previous post. If the primary endpoint (6-month RVX-208 treatment vs. baseline) is met, even if its below 0.6%, this is PLAQUE REGRESSION. Boo-yah. There is not pre-set requirement for 0.6% in the primary endpoint. This was just the value used for designing how many subjects should be in the study. It's really only if primary endpoint isn't met that we run into potential differing interpretations of the success of the trial. But as I said before, even if primary endpoint fails, one of the secondary enpoints is comparing the RVX-208 group to the placebo group. And if these two groups differ, then this is still very encouraging. All IMO. GLTA.