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Message: Re: New publications
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Oct 08, 2015 02:46PM
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Oct 09, 2015 09:31AM

Thanks Deke. I still couldn't access the ASSURE paper, but no problem.....we all know what that contains. The researchgate link worked for me to access the "An evaluation of RVX-208 for the treatment of atherosclerosis" paper. It is a review article "based on a literature search considering both animal and human studies available on PubMed as well as Media Releases from the Resverlogix Corporation."

It focused almost exclusively on the primary endpoints of the trials to date with no mention of the upcoming Phase 3 BETonMACE trial. Additionally, there was hardly any mention of MACE in the general or diabetic patients (just a brief sentence bolded below), hardly any mention of Alzheimers/AB-40, no mention of post-hoc analysis of statin type/dose in relation to synergy with RVX-208, hardly any mention of the hsCRP post-hoc analysis, no mention of alkaline phosphatase, no mention of complement cascade/orphan indications, no mention of microarray/gene expression/pathway analysis in liver cells or whole blood. It even cites a terminated trial as being conducted (second paragraph below). In the defense of the authors of this review though, it should be Resverlogix publishing peer reviewed papers on these above aspects, not another group writing a review based on news releases. Resverlogix needs to publish! Interestingly, Norman Wong is a co-author; however, he lists his University of Calgary affiliation and not his Resverlogix affiliation.

Here are the two most useful paragraphs from the paper, IMO.

"On the other hand, summarizing effects of RVX-208 in all subjects from both studies SUSTAIN and ASSURE (n = 331), all changes in lipids (HDL-C, apoA-I levels, large HDL particles, HDL particle size and total HDL particles) were increased significantly, while alkaline phosphatase decreased versus baseline. Furthermore, all these changes were significant compared with placebo (n = 166) excluding increases in total HDL particles [30]. In both SUSTAIN and ASSURE, there were a significant number of CVD events. Both trials had similar patient populations with CVD, standard of care including statins, duration of 24 -- 26 weeks and identical treatment with RVX-208 (200 mg/day). The combined events from both trials showed that RVX-208 lowered major adverse cardiac events (MACE) by 55% in CVD patients (p = 0.02) with accentuated effect in patients with diabetes mellitus. Furthermore, RVX-208 treatment lowered glucose by -0.3 mmol/l (p = 0.008) in patients with diabetes mellitus and low HDL (< 40 mg/dl) versus +0.9 mmol/l in similar patients given placebo [30,31]."

A Phase II Multiple-Dose Study to Characterize the Pharmacokinetics of RVX000222 Capsule Formulation in Combination With Either Atorvastatin or Rosuvastatin in 13 Patients With Dyslipidemia (NCT01863225) has been conducted for 14 days and completed in June 2013 [32]. There were four arms: i) 200 mg daily + atorvastatin 40 mg, ii) 200 mg daily + rosuvastatin 20 mg, iii) 200 mg daily + atorvastatin 80 mg and iv) 200 mg daily + rosuvastatin 40 mg."

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