Re: What if
in response to
by
posted on
Mar 07, 2019 09:24AM
"In retrospect IMO one of the biggest mistakes RVX management has ever made was, in ASSURE, not making the differentiation between rosuvastatin + 208 and atorvastatin + 208 a prespecified end point. To me heads should have rolled after that one."
Hindsight is 20/20. Correct me if I'm wrong, but management didn't have any indication of the synergy between rosuvastain and apabetalone until the post-hoc analysis of the ASSURE trial. It seems unfair to call for heads to roll for management and the clinical steering committee lacking clairvoyant abilities.
Additionally, it seems from this news release that only in those with below median HDL-C was the rosuvastatin + apabetalone vs. rosuvastatin + placebo effect on percent atheroma value (PAV) significant. If you look back at the rosuvastatin + apabetalone patent, you will appreciate that there are three factors that influenced apabetalone-mediated changes in PAV in ASSURE: 1) statin type; 2) statin dose; and 3) baseline HDL-C. If one looks at PAV for rosuvastatin + placebo vs. rosuvastatin + apabetalone in all rosuvastatin patients regardless of statin dose or baseline HDL, there is no difference in PAV (both -0.61%). See Figure 4 in the patent. It is only when one starts narrowing down to the below median HDL-C population that one sees the remarkable rosuvastatin + apabetalone synergy. ASSURE was already a small trial. When one starts stratifying patient groups based on statin type, statin dose and baseline HDL, the numbers of patients remaining is each sub-group get smaller and smaller. Keep these things in mind.
BearDownAZ