RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:News Release Issued: Feb 10, 2015 (12:00pm MST)Further to your informative posts TOINV, After the AGM this year I asked similar questions to those brought up today regarding the end point for BETonMACE and was told that the reason for the 20-30% end point target were that 1) 20-30% RRR would be considered to be very successful by big pharma and 2) that this endpoint could be easier and possibly quicker to achieve statistical significance with as opposed to looking for an endpoint in the 70% range. As far as the ability for BETonMACE to achieve results in the neighbourhood of 70% RRR, I think there is a good likelihood given that in ASSURE by itself the RRR was 74% in the diabetes subgroup and in SUSTAIN plus ASSURE the RRR was 77% for the same group. The post hoc analysis of SUSTAIN revealed the first set of great MACE results and this was the reason that MACE was a prespecified secondary endpoint in ASSURE.
On another subject, there were some questions raised regarding the relationship between atherosclerosis and diabetes. There is actually a fairly good blog post on the RVX website which outlines this relationship. There is also a great deal of independant research on this subject which is readily available on the internet. Further to this, I think this is a wonderful path for RVX to be going down as Dr. Wong is a well respected authority in edricrinology so this is directly in his wheelhouse (don't take my word for it, check out his CV on the UofC website.
As far as the failures in ASSURE; just my opinion but I think that the biggest failures in that study were a direct result of non adherence to the inclusion criteria (HDLC of </= 45 mg/dL (1.2 mmol/L) for females and HDLC of </=40 mg/dL (1.0 mmol/L) for males) as well as poor oversite visa vis paticipants actually taking their medication. JMO but I think this is why the Clevland Clinic won't be running the next trial.