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Cardiol Ther. 2019 Jun;8(1):79-90. doi: 10.1007/s40119-019-0131-8. Epub 2019 Feb 20.

Icosapent Ethyl Effects on Fatty Acid Profiles in Statin-Treated Patients With High Triglycerides: The Randomized, Placebo-controlled ANCHOR Study.

Cardiology and therapy

Christie M Ballantyne, Mehar S Manku, Harold E Bays, Sephy Philip, Craig Granowitz, Ralph T Doyle, Rebecca A Juliano

Affiliations

  1. Department of Medicine, Baylor College of Medicine and the Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA. [email protected].
  2. Amarin Pharma Inc, Bedminster, NJ, USA.
  3. Clinical Research, Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA.
  4. Medical Affairs, Amarin Pharma Inc, Bedminster, NJ, USA.
  5. Research and Development, Amarin Pharma Inc, Bedminster, NJ, USA.

PMID: 30788718 PMCID: PMC6525216 DOI: 10.1007/s40119-019-0131-8

Abstract

INTRODUCTION: Fatty acid content in plasma and red blood cells (RBCs) may provide insight into potential physiologic benefits of omega-3 fatty acids. Icosapent ethyl is a pure prescription form of eicosapentaenoic acid (EPA) ethyl ester approved by the US Food and Drug Administration at a dose of 4 g/day as an adjunct to diet to reduce triglyceride levels in adults with severe (≥ 500 mg/dl) hypertriglyceridemia.

METHODS: This was a prespecified exploratory subset analysis of the ANCHOR study, which randomized 702 statin-treated patients at increased cardiovascular risk with triglycerides 200-499 mg/dl and controlled low-density lipoprotein cholesterol (40-99 mg/dl). This analysis examined effects of icosapent ethyl 4 g/day versus placebo on fatty acid levels in plasma and RBCs using a gas chromatograph assay method with flame ionization detector.

RESULTS: In plasma, treatment with icosapent ethyl 4 g/day resulted in significant increases versus placebo in the mean concentrations of EPA (+ 635%; P < 0.0001) and its metabolite, docosapentaenoic acid n-3 (+ 143%; P < 0.0001) with no significant change in docosahexaenoic acid. Treatment with icosapent ethyl 4 g/day versus placebo also resulted in significant decreases in the omega-6 fatty acids linoleic acid (- 25%) and arachidonic acid (AA; - 31%), as well as the AA/EPA ratio (- 91%). Icosapent ethyl 4 g/day also decreased the omega-9 fatty acid oleic acid (- 29%) and the saturated fatty acids palmitic acid (- 23%) and stearic acid (- 16%) (all P < 0.0001). Results were similar for RBCs.

CONCLUSIONS: Icosapent ethyl 4 g/day significantly increased EPA and produced other potentially beneficial shifts in fatty acids in plasma and RBCs versus placebo.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier, NCT01047501 FUNDING: Amarin Pharma Inc. Plain language summary available for this article.

Keywords: Arachidonic acid; Eicosapentaenoic acid; Fatty acids; Hypertriglyceridemia; Icosapent ethyl; Omega-3 fatty acids; Omega-6 fatty acids

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