Thanks for posting BKC.  

This latest paper is distinct in 2 ways.

1) The previous post-hoc MACE analysis that was published in Atherosclerosis 2016 was done on the combined data from the 6-month long ASSURE and SUSTAIN trials. As described in the Atherosclerosis 2016 paper, "after combining data from [SUSTAIN and ASSURE], there was a total of 499 subjects that received either 100 mg b.i.d. of RVX-208 (n=331) or placebo (n=168). This latest paper not only includes patients from ASSURE/SUSTAIN but also includes patients from the 3-month long ASSERT trial, allowing them to perform a pooled analysis of 798 patients. Therefore, the addition of ASSERT added another 299 patients. Of note, patients in ASSERT were treated with placebo or with RVX-208 at a dose of 50, 100, or 150 mg twice daily for 12 weeks (~75 patients per subgroup), whereas the dose for ASSURE/SUSTAIN was 100 mg twice daily. So by combining all three trials, they are able to compare 242 placebo patients to 556 RVX-208 patients.

2) The Atherosclerosis 2016 article was authored entirely by Resverlogix. Importantly, the first two listed authors (Stephen Nicholls, Kausik Ray) as well as the last author (Gregory Schwartz) of this latest paper are clinicians from the BETonMACE Clinical Steering Committee. Additionally, the second to last author (Susan Wonsun Kim) is an epidemiologist/biostatistician from South Australian Health and Medical Research Institute. Yes, there are 6 Resverlogix authors, but they are buried as the middle authors. Also, this is being published in the same journal (American Journal of Cardiovascular Drugs) as the ASSURE results, by the same first author (Stephen Nicholls). Having this latest post-hoc published by these authors in this journal gives much more credence to these post-hoc studies, in my opinion.

BearDownAZ