Five year anniversary of the ASSURE top-line release was yesterday. 

Could we already be close to 250 events in BETonMACE?  Speaking of top-line.....Amarin announced today that "the last patient study visit has occurred in its potential landmark cardiovascular outcomes study, REDUCE-IT™.  The company also reiterated that it anticipates having top-line results for this important study reported before the end of Q3 2018." Recall Amarin previously announced on April 4, 2018 that the had acheived their target number of MACE.

What is really eye-opening in today's news release is this statement:

"The time between commencing last patient study visits and reporting top-line results in other large outcomes studies reviewed by the company has been approximately five to seven months. There is no reliable correlation between the length of time needed to wind down a study (i.e., the time interval between commencement of patient last site visits and reporting top-line results) and the outcome of reported results of a study.  Amarin’s anticipation of reporting top-line results before the end of Q3 2018 is consistent with the wind-down timing of these other outcomes studies, each of which were conducted by companies much larger than Amarin."

Why so long? They justify this length with the following: "As previously described, other important steps needed to complete the study include finalizing adjudication of reported events, including major adverse cardiovascular events (MACE) within the primary endpoint, securing final vital status data from inactive patients, and completing the review of data for consistency and completeness across more than 35,000 patient years in the trial."

BETonMACE has less target MACE, less patients, and less patient years. But still this Amarin example exemplifies the long adjudication process that Tada has so often reminded me about (thanks Tada!)

ESC 2018. I previously posted about the ESC 2018 symposium presentation entitled "LDL-c: Done Deal, Next Epigenetics?" and a late-breaking presentation by Kausik Ray. Late breaker titles are out today. Looks like Kausik's presentation will be Sat August 25th on the Esperion bempedoic acid entitled "CLEAR Harmony ‑ Long‑term safety, tolerability and efficacy of bempedoic acid vs. placebo in high cardiovascular risk patients with LDL‑C above 1.8 mmol/L on maximally tolerated statin therapy."

I also now see the Ewelina Kulikowski from Resverlogix will present an oral late breaker presentation on Monday August 27th entitled "Apabetalone (RVX-208) Reduces Monocyte-Endothelial Cell Adhesion and Expression of Key Vascular Inflammation Markers in Monocytes, Endothelial Cells and in Inflamed Mouse Aorta." This title seems very similar to abstract 257 presented by Resverlogix at Vascular Discovery 2018 back May 10-12, 2018. There will very likely be some new stuff in upcoming August ESC presentation since the submission deadline for Vascular Discovery was Jan 10, 2018 and late breaker submission deadline for ESC was April 4th, 2018.