Abstract 15922: Icosapent Ethyl (Eicosapentaenoic Acid Ethyl Ester) in Statin-treated Women With Persistent High Triglycerides: Results From the ANCHOR Study
Introduction: Few studies examined novel triglyceride (TG)-lowering therapies in women, despite elevated TGs being a stronger predictor of cardiovascular disease (CVD) in women than men.
Hypothesis: To conduct a subgroup analysis of the effect of icosapent ethyl (IPE), a high-purity prescription form of eicosapentaenoic acid (EPA) ethyl ester 4 g/day vs placebo on TGs (primary efficacy variable), and other atherogenic and inflammatory parameters among women in the 12-week placebo-controlled ANCHOR study.
Methods: ANCHOR randomized 702 statin-treated patients (39% women) at increased CVD risk with TGs 200-499 mg/dL despite low-density lipoprotein cholesterol (LDL-C) control (40- <100 mg/dL) to IPE 2 g/day, 4 g/day, or placebo. This post hoc analysis included 179 women (97% white, 82% with diabetes, mean age = 62 years) randomized to IPE 4 g/day (n=91) or placebo (n=88). We conducted non-parametric analyses of median difference in percent change from baseline to week 12 in lipids, lipoproteins, inflammatory markers. In a smaller subset of women, plasma (n=29) and red blood cell (RBC) EPA (n=27) levels were analyzed and compared with placebo (n=32 for plasma, n=31 for RBC).
Results: IPE 4 g/day (n=87) significantly reduced TGs (–22%; P<0.0001) without increasing LDL-C (–6%; P>0.05) vs placebo (n=86) in women from the ANCHOR study. Significant improvements in other atherogenic and inflammatory parameters were also observed vs placebo (Figure). IPE 4 g/day significantly increased plasma (+667%; P<0.0001) and RBC EPA (+619%; P<0.0001) vs placebo. Discontinuations due to adverse events were low (n=4 in each group).
Conclusions: Among statin-treated women with baseline TGs 200-499 mg/dL, IPE 4 g/day significantly reduced TGs and several other atherogenic and inflammatory parameters without increasing LDL-C compared with placebo. The clinical implications of these findings are being evaluated in the REDUCE-IT cardiovascular outcomes study.
Author Disclosures: L. Mosca: Consultant/Advisory Board; Significant; Amarin Pharma Inc. C.M. Ballantyne: Consultant/Advisory Board; Modest; Abbott Diagnostics, Amarin, Amgen, Eli Lilly, Esperion, Ionis, Matinas BioPharma Inc, Novartis, Regeneron, Roche Diagnostic. Research Grant; Significant; NIH, AHA, ADA. Other Research Support; Significant; Abbott Diagnostic, Amarin, Amgen, Eli Lilly, Esperion, Ionis, Novartis, Pfizer, Regeneron, Roche Diagnostic, Sanofi-Synthelabo. Consultant/Advisory Board; Significant; Astra Zeneca, Merck, Pfizer, Sanofi-Synthelabo. H.E. Bays: Research Grant; Significant; Amarin Pharma Inc., Amgen, Ardea, Arisaph, AstraZeneca, Bristol-Myers Squibb, Catabasis, Cymabay, Eisai, Elcelyx, Eli Lilly, Esperion, Ferrer/Chiltern, Gilead, GSK, Hanmi, Hisun, Hoffman LaRoche, Home Access, Janssen, Johnson & Johnson, Kowa, Merck, Nektar, Novartis, NovoNordisk, Omthera, Orexigen, Pfizer, Pronova, Regeneron, Sanofi, Takeda, TIMI. Speakers Bureau; Significant; Amarin Pharma Inc., Amgen, AstraZeneca, Eisai, Orexigen, Regeneron, Sanofi, Takeda. Consultant/Advisory Board; Modest; Akcea, Alnylam, Catabasis, Eli Lilly, Ionis, Janssen, Johnson & Johnson, Novartis, Pronova. Consultant/Advisory Board; Significant; Amgen, AstraZeneca, Merck, Regeneron, Sanofi, Takeda. J.R. Guyton: Research Grant; Modest; Amarin Pharma Inc., Amgen. Research Grant; Significant; Regeneron, Sanofi. Consultant/Advisory Board; Modest; Amgen, FH Foundation. S. Philip: Employment; Significant; Amarin Pharma Inc. S. Chowdhury: Consultant/Advisory Board; Modest; Amarin Pharma Inc. R.T. Doyle: Employment; Significant; Amarin Pharma Inc. R.A. Juliano: Employment; Significant; Amarin Pharma Inc..
- © 2016 by American Heart Association, Inc.