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Re: jessellivermore post# 23508

Tuesday, 01/07/2014 11:11:17 AM

Tuesday, January 07, 2014 11:11:17 AM

Post# of 427734
The exact reason why Vascepa should have had (Anchor sNDA)approved by the FDA. It enhances of Statin anti-inflammatory effect(hsCRP)/LDL-C lowering effect which is proven to reduce heart failure. A real no brainer for the FDA.

ANCHOR studies, this newly published analysis of these studies shows that Vascepa 4g/day significantly decreased levels of several inflammatory markers relative to placebo, including oxidized low-density lipoprotein (Ox-LDL), lipoprotein-associated phospholipase A2 (Lp-PLA2), and high sensitivity C-reactive protein (hsCRP).

"Statins are known to decrease hsCRP levels, and subjects in both MARINE and ANCHOR who received statin therapy were on stable therapy prior to administration of Vascepa," stated Steve Ketchum, Ph.D., President of Research and Development for Amarin. "The effects of Vascepa on inflammatory markers described in this publication were in addition to effects already achieved with statins. It is of interest that in ANCHOR, Vascepa decreased hsCRP more in higher-efficacy statin regimens, which is consistent with the previously reported ANCHOR findings of higher triglyceride reductions in patients with higher-efficacy statin regimens."
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