Overview of Prescription Omega-3 Fatty Acid Products for Hypertriglyceridemia

References

• . Ginsberg HN. Hypertriglyceridemia: new insights and new approaches to pharmacologic therapy. Am J Cardiol. 2001;87(10):1174–1180
   PubMed Web of Science ®Google Scholar
• . Assmann G, Schulte H, von EA. Hypertriglyceridemia and elevated lipoprotein(a) are risk factors for major coronary events in middle-aged men. Am J Cardiol. 1996;77(14):1179–1184
   PubMed Web of Science ®Google Scholar
• . Stampfer MJ, Krauss RM, Ma J,. A prospective study of triglyceride level, low-density lipoprotein particle diameter, and risk of myocardial infarction. JAMA. 1996;276(11):882–888
   PubMed Web of Science ®Google Scholar
• . Jeppesen J, Hein HO, Suadicani P, Gyntelberg F. Triglyceride concentration and ischemic heart disease: an eight-year follow-up in the Copenhagen Male Study [published correction appears in Circulation. 1998;97(19):1995]. Circulation. 1998;97(11):1029–1036
   PubMed Web of Science ®Google Scholar
• . National Cholestrol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholestrol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143–3421
   PubMed Web of Science ®Google Scholar
• . Miller M, Stone NJ, Ballantyne C,; American Heart Association Clinical Lipidology, Thrombosis, and Prevention Committee of the Council on Nutrition, Physical Activity, and Metabolism; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123(20):2292–2333
   PubMed Web of Science ®Google Scholar
• . Berglund L, Brunzell JD, Goldberg AC,; Endocrine Society. Evaluation and treatment of hypertriglyceridemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(9):2969–2989
   PubMed Web of Science ®Google Scholar
• . Cohen JD, Cziraky MJ, Cai Q,. 30-year trends in serum lipids among United States adults: results from the National Health and Nutrition Examination Surveys II, III, and 1999–2006. Am J Cardiol. 2010;106(7):969–975
   PubMed Web of Science ®Google Scholar
• . Ford ES, Li C, Zhao G, Pearson WS, Mokdad AH. Hypertriglyceridemia and its pharmacologic treatment among US adults. Arch Intern Med. 2009;169(6):572–578
   PubMedGoogle Scholar
• . Stone NJ, Robinson J, Lichtenstein AH,; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published correction appears in J Am Coll Cardiol. 2014;63(25 Pt B):3024–3025]. J Am Coll Cardiol. 2014;63(25 Pt B):2889–2934
   PubMed Web of Science ®Google Scholar
• . Balk EM, Lichtenstein AH, Chung M, Kupelnick B, Chew P, Lau J. Effects of omega-3 fatty acids on serum markers of cardiovascular disease risk: a systematic review. Atherosclerosis. 2006;189(1):19–30
   PubMed Web of Science ®Google Scholar
• . Bays H. Fish oils in the treatment of dyslipidemia and cardiovascular disease. In: Kwiterovich PO Jr, ed. The Johns Hopkins Textbook of Dyslipidemia. Philadelphia, PA: Lippincott Williams & Wilkins/Wolters Kluwer Health; 2010:245–257
   Google Scholar
• . Calder PC. n-3 Fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clin Sci (Lond). 2004;107(1):1–11
   PubMed Web of Science ®Google Scholar
• . Delgado-Lista J, Perez-Martinez P, Lopez-Miranda J, Perez-Jimenez F. Long chain omega-3 fatty acids and cardiovascular disease: a systematic review. Br J Nutr. 2012;107( Suppl 2):S201–S213
   PubMed Web of Science ®Google Scholar
• . Kris-Etherton PM, Harris WS, Appel LJ; American Heart Association. Nutrition Committee. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease [published correction appears in Circulation. 2003;107(3):512]. Circulation. 2002;106(21):2747–2757
   PubMed Web of Science ®Google Scholar
• . Kris-Etherton PM, Harris WS, Appel LJ; AHA Nutrition Committee, American Heart Association. Omega-3 fatty acids and cardiovascular disease: new recommendations from the American Heart Association. Arterioscler Thromb Vasc Biol. 2003;23(2):151–152
   PubMed Web of Science ®Google Scholar
• . Lavie CJ, Milani RV, Mehra MR, Ventura HO. Omega-3 polyunsaturated fatty acids and cardiovascular diseases. J Am Coll Cardiol. 2009;54(7):585–594
   PubMed Web of Science ®Google Scholar
• . Schunkert H, König IR, Kathiresan S,; CARDIoGRAM Consortium, Samani NJ. Large-scale association analysis identifies 13 new susceptibility loci for coronary artery disease. Nat Genet. 2011;43(4):333–338
   PubMed Web of Science ®Google Scholar
• . Miller PE, Van Elswyk M, Alexander DD. Long-chain omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid and blood pressure: a meta-analysis of randomized controlled trials. Am J Hypertens. 2014;27(7):885–896
   PubMed Web of Science ®Google Scholar
• . Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-Prevenzione trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico [published corrections appear in Lancet. 2001;357(9256):642, and Lancet. 2007;369(9556):106]. Lancet. 1999;354(9177):447–455
   PubMed Web of Science ®Google Scholar
• . ; Gissi-HF InvestigatorsTavazzi L, Maggioni AP, Marchili R,. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372(9645):1223–1230
   PubMed Web of Science ®Google Scholar
• . Kromhout D, Giltay EJ, Geleijnse JM; Alpha Omega Trial Group. n-3 fatty acids and cardiovascular events after myocardial infarction. N Engl J Med. 2010;363(21):2015–2026
   PubMed Web of Science ®Google Scholar
• . ; ORIGIN Trial InvestigatorsBosch J, Gerstein HC, Dagenais GR,. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012;367(4):309–318
   PubMed Web of Science ®Google Scholar
• . Rauch B, Schiele R, Schneider S,; OMEGA Study Group. OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction. Circulation. 2010;122(21):2152–2159
   PubMed Web of Science ®Google Scholar
• . Yokoyama M, Origasa H, Matsuzaki M,; Japan EPA lipid intervention study (JELIS) Investigators. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis [published correction appears in Lancet. 2007;370(9583):220]. Lancet. 2007;369(9567):1090–1098
   PubMed Web of Science ®Google Scholar
• . Saito Y, Yokoyama M, Origasa H,; JELIS Investigators, Japan. Effects of EPA on coronary artery disease in hypercholesterolemic patients with multiple risk factors: sub-analysis of primary prevention cases from the Japan EPA Lipid Intervention Study (JELIS) [published correction appears in Atherosclerosis. 2009;204(1):233]. Atherosclerosis. 2008;200(1):135–140
   PubMed Web of Science ®Google Scholar
• . Mozaffarian D, Marchioli R, Macchia A,; OPERA Investigators. Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial [published correction appears in JAMA. 2013;309(9):876]. JAMA. 2012;308(19):2001–2011
   PubMed Web of Science ®Google Scholar
• . Larsson SC, Orsini N, Wolk A. Long-chain omega-3 polyunsaturated fatty acids and risk of stroke: a meta-analysis. Eur J Epidemiol. 2012;27(12):895–901
   PubMed Web of Science ®Google Scholar
• . ; The Risk and Prevention Study Collaborative GroupRoncaglioni MC, Tombesi M, Avanzini F,. n-3 fatty acids in patients with multiple cardiovascular risk factors [published correction appears in N Engl J Med. 2013;368(22):2146]. N Engl J Med. 2013;368(19):1800–1808
   PubMedGoogle Scholar
• . Lovaza [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2014
   Google Scholar
• . Omtryg [package insert]. Arlington, VA: Trygg Pharma, Inc.; 2014
   Google Scholar
• . Vascepa [package insert]. Bedminster, NJ: Amarin Pharma Inc.; 2013
   Google Scholar
• . Epanova [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2014
   Google Scholar
• . Omega-3 acid ethyl esters [package insert]. Spring Valley, NY: Par Pharmaceuticals Companies, Inc.; 2014
   Google Scholar
• . Omega-3 acid ethyl esters [package insert]. Sellersville, PA: Teva Pharmaceuticals; 2014
   Google Scholar
• . Kastelein JJ, Maki KC, Susekov A,. Omega-3 free fatty acids for the treatment of severe hypertriglyceridemia: the EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) trial. J Clin Lipidol. 2014;8(1):94–106
   PubMed Web of Science ®Google Scholar
• . Offman E, Marenco T, Ferber S,. Steady-state bioavailability of prescription omega-3 on a low-fat diet is significantly improved with a free fatty acid formulation compared with an ethyl ester formulation: the ECLIPSE II study. Vasc Health Risk Manag. 2013;9:563–573
   PubMedGoogle Scholar
• . Harris WS, Bulchandani D. Why do omega-3 fatty acids lower serum triglycerides? Curr Opin Lipidol. 2006;17(4):387–393
   PubMed Web of Science ®Google Scholar
• . Bays HE, Tighe AP, Sadovsky R, Davidson MH. Prescription omega-3 fatty acids and their lipid effects: physiologic mechanisms of action and clinical implications. Expert Rev Cardiovasc Ther. 2008;6(3):391–409
   PubMedGoogle Scholar
• . US Food and Drug Administration. Drugs @FDA: Epanova. http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed June 11, 2014
   Google Scholar
• . US Food and Drug Administration. Drugs @FDA: Vascepa. http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed June 11, 2014
   Google Scholar
• . Harris WS, Ginsberg HN, Arunakul N,. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk. 1997;4(5–6):385–391
   PubMedGoogle Scholar
• . Pownall HJ, Brauchi D, Kilinç C,. Correlation of serum triglyceride and its reduction by omega-3 fatty acids with lipid transfer activity and the neutral lipid compositions of high-density and low-density lipoproteins. Atherosclerosis. 1999;143(2):285–297
   PubMed Web of Science ®Google Scholar
• . Bays HE, Ballantyne CM, Kastelein JJ, Isaacsohn JL, Braeckman RA, Soni PN. Eicosapentaenoic acid ethyl ester (AMR101) therapy in patients with very high triglyceride levels (from the Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week study with an open-label Extension [MARINE] trial). Am J Cardiol. 2011;108(5):682–690
   PubMed Web of Science ®Google Scholar
• . National Institutes of Health. Efficacy study to treat subjects with severe hypertriglyceridemia. ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT01229566. Updated November 23, 2011. Accessed October 2, 2014
   Google Scholar
• . Lovaza [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2013
   Google Scholar
• . Davidson MH, Stein EA, Bays HE,; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study. Clin Ther. 2007;29(7):1354–1367
   PubMed Web of Science ®Google Scholar
• . Ballantyne CM, Bays HE, Kastelein JJ,. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012;110(7):984–992
   PubMed Web of Science ®Google Scholar
• . Maki KC, Orloff DG, Nicholls SJ,. A highly bioavailable omega-3 free fatty acid formulation improves the cardiovascular risk profile in high-risk, statin-treated patients with residual hypertriglyceridemia (the ESPRIT trial). Clin Ther. 2013;35(9):1400–1411
   PubMed Web of Science ®Google Scholar
• . RED BOOK. Lovaza Pricing Information. 2013. Truven Health Analytics. http://www.redbook.com/redbook/. Accessed August 14, 2014
   Google Scholar
• . Bays HE, Ballantyne CM, Braeckman RA, Stirtan WG, Soni PN. Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies. Am J Cardiovasc Drugs. 2013;13(1):37–46
   PubMed Web of Science ®Google Scholar
• . Braeckman RA, Bays HE, Ballantyne CM, Stirtan WG, Soni PN. Pharmacokinetic and triglyceride-lowering pharmacodynamic effects of icosapent ethyl (eicosapentaenoic acid ethyl ester) across clinical studies [abstract]. Circulation. 2013;128:A19343
   Web of Science ®Google Scholar
• . Jacobson TA, Glickstein SB, Rowe JD, Soni PN. Effects of eicosapentaenoic acid and docosahexaenoic acid on low-density lipoprotein cholesterol and other lipids: a review. J Clin Lipidol. 2012;6(1):5–18
   PubMed Web of Science ®Google Scholar
• . Wei MY, Jacobson TA. Effects of eicosapentaenoic acid versus docosahexaenoic acid on serum lipids: a systematic review and meta-analysis [published correction appears in Curr Atheroscler Rep. 2012;14(1):93]. Curr Atheroscler Rep. 2011;13(6):474–483
   PubMed Web of Science ®Google Scholar
• . Grundy SM, Cleeman JI, Merz CN,; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines [published correction appears in Circulation. 2004;110(6):763]. Circulation. 2004;110(2):227–239
   PubMed Web of Science ®Google Scholar
• . Panel AP. Reducing residual cardiovascular risk: the relevance of raising high-density lipoprotein cholesterol in patients on cholesterol-lowering treatment. Diab Vasc Dis Res. 2006;3(2):S1–S12
   Google Scholar
• . Gordon T, Kannel WB, Castelli WP, Dawber TR. Lipoproteins, cardiovascular disease, and death. The Framingham study. Arch Intern Med. 1981;141(9):1128–1131
   PubMedGoogle Scholar
• . Ishida T, Ohta M, Nakakuki M,. Distinct regulation of plasma LDL cholesterol by eicosapentaenoic acid and docosahexaenoic acid in high fat diet-fed hamsters: participation of cholesterol ester transfer protein and LDL receptor. Prostaglandins Leukot Essent Fatty Acids. 2013;88(4):281–288
   PubMed Web of Science ®Google Scholar
• . Jacobson TA, Ito MK, Maki KC,. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 – executive summary. J Clin Lipidol. 2014;8(5):473–488
   PubMed Web of Science ®Google Scholar
• . Avandia [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2014
   Google Scholar
• . Farxiga [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2014
   Google Scholar
• . Jardiance [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2014
   Google Scholar
• . Invokana [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2014
   Google Scholar
• . Hilleman DE, Malesker MA. Potential benefits of icosapent ethyl on the lipid profile: case studies. Clin Med Insights Cardiol. 2014;8:13–15
   PubMedGoogle Scholar
• . Castaldo RS. A retrospective case series of the lipid effects of switching from omega-3 fatty acid ethyl esters to icosapent ethyl in hyperlipidemic patients. Postgrad Med. 2014;126(3):268–273
   PubMed Web of Science ®Google Scholar
• . Davidson MH, Johnson J, Rooney MW, Kyle ML, Kling DF. A novel omega-3 free fatty acid formulation has dramatically improved bioavailability during a low-fat diet compared with omega-3-acid ethyl esters: the ECLIPSE (Epanova compared to Lovaza in a pharmacokinetic single-dose evaluation) study. J Clin Lipidol. 2012;6(6):573–584
   PubMed Web of Science ®Google Scholar
• . Itakura H, Yokoyama M, Matsuzaki M,; JELIS Investigators. Relationships between plasma fatty acid composition and coronary artery disease. J Atheroscler Thromb. 2011;18(2):99–107
   PubMed Web of Science ®Google Scholar
• . Weber C, Noels H. Atherosclerosis: current pathogenesis and therapeutic options. Nat Med. 2011;17(11):1410–1422
   PubMed Web of Science ®Google Scholar
• . Thies F, Garry JM, Yaqoob P,. Association of n-3 polyunsaturated fatty acids with stability of atherosclerotic plaques: a randomised controlled trial. Lancet. 2003;361(9356):477–485
   PubMed Web of Science ®Google Scholar
• . Cawood AL, Ding R, Napper FL,. Eicosapentaenoic acid (EPA) from highly concentrated n-3 fatty acid ethyl esters is incorporated into advanced atherosclerotic plaques and higher plaque EPA is associated with decreased plaque inflammation and increased stability. Atherosclerosis. 2010;212(1):252–259
   PubMed Web of Science ®Google Scholar
• . Bays HE, Ballantyne CM, Braeckman RA, Stirtan WG, Soni PN. Icosapent ethyl, a pure ethyl ester of eicosapentaenoic acid: effects on circulating markers of inflammation from the MARINE and ANCHOR studies. Am J Cardiovasc Drugs. 2013;13(1):37–46
   PubMed Web of Science ®Google Scholar
• . Nishio R, Shinke T, Otake H,. Stabilizing effect of combined eicosapentaenoic acid and statin therapy on coronary thin-cap fibroatheroma. Atherosclerosis. 2014;234(1):114–119
   PubMed Web of Science ®Google Scholar
• . National Insitutes of Health. A study of AMR101 to evaluate its ability to reduce cardiovascular events in high risk patients with hypertriglyceridemia and on statin the primary objective is to evaluate the effect of 4 g/day AMR101 for preventing the occurrence of a first major cardiovascular event (REDUCE-IT). ClinicalTrials.gov. http://clinicaltrials.gov/show/NCT01492361. Updated October 11, 2013. Accessed October 2, 2014
   Google Scholar
• . National Institutes of Health. Outcomes Study of Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH). ClinicalTrials.gov. http://clinicaltrials.gov/ct2/show/NCT02104817?term=strength+and+omega-3&rank=3. Updated September 24, 2014. Accessed October 2, 2014
   Google Scholar
• . Zargar A, Ito MK. Long chain omega-3 dietary supplements: a review of the National Library of Medicine Herbal Supplement Database. Metab Syndr Relat Disord. 2011;9(4):255–271
   PubMed Web of Science ®Google Scholar
• . Tur JA, Bibiloni MM, Sureda A, Pons A. Dietary sources of omega 3 fatty acids: public health risks and benefits. Br J Nutr. 2012;107( Suppl 2):S23–S52
   PubMed Web of Science ®Google Scholar
• . Weintraub H. Update on marine omega-3 fatty acids: management of dyslipidemia and current omega-3 treatment options. Atherosclerosis. 2013;230(2):381–389
   PubMed Web of Science ®Google Scholar
• . Weitz D, Weintraub H, Fisher E, Schwartzbard AZ. Fish oil for the treatment of cardiovascular disease. Cardiol Rev. 2010;18(5):258–263
   PubMed Web of Science ®Google Scholar
• . Truong P, Johnson C, Gabriel D. Variability of cholesterol and saturated fat content in dietary supplements [abstract]. Circulation. 2007;115(8):e238
   Web of Science ®Google Scholar
• . Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. 2013. Us Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed October 20, 2014
   Google Scholar