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Wednesday, May 29, 2013 6:43:47 PM
Session: AOS.202.02-Lipid and Lipoprotein Metabolism: Clinical HDL and Triglycerides
Presentation: 19030 - Apolipoprotein C-III is Significantly Reduced by Prescription Omega-3 Free Fatty Acids (Epanova) in Patients with Severe Hypertriglyceridemia and Changes Correlate with Increases in LDL-C: A Sub-analysis of the EVOLVE trial
Pres Time: Wednesday, Nov 07, 2012, 10:00 AM -10:15 AM
Location: Room 503
Pres. Time: Wednesday, Nov 07, 2012, 10:00 AM -10:15 AM
Specialty: +202. Lipid and Lipoprotein Metabolism: Clinical
Keywords: Lipoproteins; Lipids; Lipoproteins
Authors: Daniel J Rader, Richard L Dunbar, Univ of Pennsylvania Med. Ctr, Philadelphia, PA; Kevin C Maki, Biofortis Clinical Res, Addison, IL; Terry A Jacobson, Emory Univ, Atlanta, GA; Douglas Kling, Michael H Davidson, Omthera Pharmaceuticals, Inc., Princeton, NJ
Abstract: Background: Apolipoprotein C-III (apoC-III) inhibits lipoprotein lipase activity and hepatic uptake of triglyceride-rich lipoproteins. Elevated levels of apoC-III have been found to be an independent predictor for CHD risk and genetically reduced apoC-III is associated with protection from CHD, making apoC-III a therapeutic target. Omega-3 fatty acid formulations containing docosahexaenoic acid (DHA) have been shown to increase LDL-C in patients with severe hypertriglyceridemia (HTG). Clinical data suggest that eicosapentaenoic acid (EPA) alone, which lowers triglycerides to a similar extent as EPA + DHA, does not raise LDL-C, but also fails to lower apoC-III.
Materials: The EVOLVE trial evaluated 2, 3, and 4 g/d of a novel omega-3 free-fatty acid (FFA) formulation containing both EPA + DHA compared with 4 g/d of olive oil. In 399 patients with severe HTG we evaluated the effects on plasma apoC-III levels and the correlations between change in apoC-III and change in plasma lipids (TG, LDL-C) after 12-weeks of therapy.
Results: Epanova 2, 3, and 4 g/d produced significant median reductions in apoC-III by 9 (p=0.02), 13 (p=0.006), and 15% (p<0.001), respectively, compared to olive oil (+5%). Epanova produced significant (p<0.001) median reductions in triglycerides (TG) of 26, 22, and 31%, respectively, compared to 10% for olive oil, and significant (p<0.001) median increases in LDL-C of 21, 16, 26%, respectively, compared to 10% for olive oil. There was a significant positive correlation between percent changes in apoC-III and triglycerides (r=0.603, p<0.001) and a significant negative correlation between percent changes in apoC-III and LDL-C concentrations (r=-0.28, p<0.001).
Conclusion: A novel omega-3 FFA formulation containing both EPA and DHA significantly lowered apoC-III levels in addition to reducing TG levels. An increase in LDL-C correlated with the reduction in apoC-III. Since EPA alone does not appear to lower apoC-III, these results support the hypothesis that DHA has specific effects in lowering apoC-III and that the mechanism by which DHA increases LDL-C may be related to its effect to lower apo CIII.
Disclosures: D.J. Rader, Omthera Pharmaceuticals, Inc., Modest,Consultant/Advisory Board; R.L. Dunbar, None; K.C. Maki, DSM, Modest,Research Grant; GSK, Significant,Research Grant; Abbott, Significant,Research Grant; Pharmavite, Significant,Research Grant; Trygg, Significant,Consultant/Advisory Board; Omthera Pharmaceuticals, Inc., Significant,Consultant/Advisory Board; T.A. Jacobson, Amarin, Modest,Consultant/Advisory Board; Abbott, Modest,Consultant/Advisory Board; GSK, Modest,Consultant/Advisory Board; Omthera Pharmaceuticals, Inc., Modest,Consultant/Advisory Board; D. Kling, Omthera Pharmaceuticals, Inc., Significant,Employment; Omthera Pharmaceuticals, Inc., Significant,Ownership Interest; M.H. Davidson, Amgen, Modest,Consultant/Advisory Board; AstraZeneca, Modest,Consultant/Advisory Board; sanofi-aventis, Modest,Consultant/Advisory Board; Omthera Pharmaceuticals, Inc, Significant,Employment; Omthera Pharmaceuticals, Inc, Significant,Ownership Interest; Merck & Co., Significant,Consultant/Advisory Board.
EPANOVA
http://www.abstractsonline.com/plan/ViewAbstract.aspx?mID=2974&sKey=a073c55d-dc7b-46a2-a682-4fe610e8400b&cKey=39a148c5-21af-42f5-bf2e-2aa71314190d&mKey=%7B14145D5B-F96B-4354-8237-8F0937744BA4%7D
In my opinion AZN bought a capsule Patent and that's it.
Williams
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