A comparative overview of prescription omega-3 fatty acid products

P and T

Volumn 40, Issue 12, 2015, Pages

  Ito, Matthew K ^a  

^a OREGON STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

APOLIPOPROTEIN C3; ATORVASTATIN; DOCOSAHEXAENOIC ACID; ICOSAPENTAENOIC ACID; ICOSAPENTAENOIC ACID ETHYL ESTER; LOW DENSITY LIPOPROTEIN CHOLESTEROL; OMEGA 3 FATTY ACID; OMEPRAZOLE; ROSIGLITAZONE; ROSUVASTATIN; SIMVASTATIN; TRIACYLGLYCEROL; WARFARIN;

ABDOMINAL PAIN; ARTHRALGIA; ARTICLE; CARDIOVASCULAR RISK; COMPARATIVE STUDY; COST EFFECTIVENESS ANALYSIS; DIARRHEA; DIET SUPPLEMENTATION; DRUG INTERACTION; DYSPEPSIA; ERUCTATION; HEALTH CARE COST; HEALTH CARE UTILIZATION; HYPERTRIGLYCERIDEMIA; ISCHEMIC HEART DISEASE; NAUSEA; SEDENTARY LIFESTYLE;

EID: 84961997813     PISSN: 10521372     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (100)

1. Lovaza prescribing information Research Triangle Park, North Carolina: GlaxoSmithKline. 2014
2. Omtryg prescribing information Arlington, Virginia: Trygg Pharma, Inc.. 2014
3. Epanova prescribing information Wilmington, Delaware: Astra-Zeneca Pharmaceuticals LP. 2014
4. Vascepa prescribing information Bedminster New Jersey: Amarin Pharma Inc. 2015
5. 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.
6. Austin MA, Hokanson JE, Edwards KL. Hypertriglyceridemia as a cardiovascular risk factor. Am J Cardiol 1998, 81, (4A):7B-12B.
7. Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation 2011, 123, (20): 2292-2333.
8. Carroll M, Kit B, Lacher D. Trends in elevated triglyceride in adults: United States, 2001-2012. NCHS Data Brief 2015, 1981-8.
9. Stone NJ. Secondary causes of hyperlipidemia. Med Clin North Am 1994, 78, (1):117-141.
10. Chait A, Brunzell JD. Acquired hyperlipidemia (secondary dyslipoproteinemias). Endocrinol Metab Clin North Am 1990, 19, (2):259-278.
11. Ginsberg HN. Hypertriglyceridemia: new insights and new approaches to pharmacologic therapy. Am J Cardiol 2001, 87, (10):1174-1180.
12. Jorgensen AB, Frikke-Schmidt R, Nordestgaard BG, Tybjaerg-Hansen A. Loss-of-function mutations in APOC3 and risk of ischemic vascular disease. N Engl J Med 2014, 371, (1):32-41.
13. TG and HDL Working Group of the Exome Sequencing Project NHLaBI. Loss-of-function mutations in APOC3, triglycerides, and coronary disease. N Engl J Med 2014, 371, (1):22-31.
14. Nichols GA, Arondekar B, Garrison LP Jr. Patient characteristics and medical care costs associated with hypertriglyceridemia. Am J Cardiol 2011, 107, (2):225-229.
15. Toth PP, Grabner M, Ramey N, Higuchi K. Clinical and economic outcomes in a real-world population of patients with elevated triglyceride levels. Atherosclerosis 2014, 237, (2):790-797.
16. Nichols GA, Arondekar B, Jacobson TA. Hospital use and medical care costs up to 5 years after triglyceride lowering among patients with severe hypertriglyceridemia. J Clin Lipidol 2012, 6(5):443-449.
17. Christian JB, Arondekar B, Buysman E, et al. Clinical and economic benefits observed when follow-up triglyceride levels are less than 500 mg/dL in patients with severe hypertriglyceridemia. J Clin Lipidol 2012, 6, (5):450-461.
18. Christian JB, Arondekar B, Buysman EK, et al. Determining triglyceride reductions needed for clinical impact in severe hypertriglyceridemia. Am J Med 2014, 127, (1):36-44.
19. Kastelein JJP, Maki KC, Susekov A, et al. 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):94-108.
20. Offman E, Marenco T, Ferber S, et al. 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.
21. Braeckman RA, Bays HE, Ballantyne CM, et al. Pharmacokinetic and triglyceride-lowering pharmacodynamic effects of icosapent ethyl (eicosapentaenoic acid ethyl ester) across clinical studies. Poster presentation at the Annual Scientific Sessions of the American Heart Association Dallas, Texas November 16-20, 2013
22. Maki KC, Orloff DG, Nicholls SJ, et al. 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.
23. Braeckman RA, Stirtan WG, Soni PN. Phase 1 study of the effect of icosapent ethyl on warfarin pharmacokinetic and anticoagulation parameters. Clin Drug Investig 2014, 34, (7):449-456.
24. Braeckman RA, Stirtan WG, Soni PN. Effect of icosapent ethyl (eicosapentaenoic acid ethyl ester) on omeprazole plasma pharmacokinetics in healthy adults. Drugs R D 2014, 14, (3):159-164.
25. McKenney JM, Swearingen D, Di Spirito M, et al. Study of the pharmacokinetic interaction between simvastatin and prescription omega-3-acid ethyl esters. J Clin Pharmacol 2006, 46, (7):785-791.
26. Gosai P, Liu J, Doyle RT, et al. Effect of omega-3-acid ethyl esters on the steady-state plasma pharmacokinetics of rosuvastatin in healthy adults. Expert Opin Pharmacother 2008, 9, (17):2947-2953.
27. Di Spirito M, Morelli G, Doyle RT, et al. Effect of omega-3-acid ethyl esters on steady-state plasma pharmacokinetics of atorvastatin in healthy adults. Expert Opin Pharmacother 2008, 9, (17):2939-2945.
28. Braeckman RA, Stirtan WG, Soni PN. Effects of icosapent ethyl (eicosapentaenoic acid ethyl ester) on pharmacokinetic parameters of rosiglitazone in healthy subjects. Clin Pharmacol Drug Dev 2015, 4, (2):143-148.
29. Bays HE. Safety considerations with omega-3 fatty acid therapy. Am J Cardiol 2007, 99, (6A):35C-43C.
30. Harris WS. Expert opinion: omega-3 fatty acids and bleeding— cause for concern?. Am J Cardiol 2007, 99, (6A):44C-46C.
31. Wachira JK, Larson MK, Harris WS. N-3 fatty acids affect haemostasis but do not increase the risk of bleeding: clinical observations and mechanistic insights. Br J Nutr 2014, 111, (9):1652-1662.
32. Harris WS, Ginsberg HN, Arunakul N, et al. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk 1997, 4, (5-6):385-391.
33. Pownall HJ, Brauchi D, Kilinc C, et al. 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.
34. Bays HE, Ballantyne CM, Kastelein JJ, et al. 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.
35. Davidson MH, Stein EA, Bays HE, et al. 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.
36. Ballantyne CM, Bays HE, Kastelein JJ, et al. 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.
37. Lovaza prescribing information Research Triangle Park, North Carolina: GlaxoSmithKline. 2013
38. Davidson MH, Johnson J, Rooney MW, et al. 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.
39. Nelson SD, Munger MA. Icosapent ethyl for treatment of elevated triglyceride levels. Ann Pharmacother 2013, 47, (11):1517-1523.
40. Niaspan prescribing information North Chicago, Illinois: AbbVie Inc. 2015
41. Trilipix prescribing information North Chicago, Illinois: AbbVie Inc. 2015
42. Samuel S, Peskin B, Arondekar B, et al. Estimating health and economic benefits from using prescription omega-3 fatty acids in patients with severe hypertriglyceridemia. Am J Cardiol 2011, 108:691-697.
43. Cowie MR, Cure S, Bianic F, et al. Cost-effectiveness of highly purified omega-3 polyunsaturated fatty acid ethyl esters in the treatment of chronic heart failure: results of Markov modelling in a UK setting. Eur J Heart Fail 2011, 13, (6):681-689.
44. Schmier JK, Rachman NJ, Halpern MT. The cost-effectiveness of omega-3 supplements for prevention of secondary coronary events. Manag Care 2006, 15, (4):43-50.
45. Franzosi MG, Brunetti M, Marchioli R, et al. Cost-effectiveness analysis of n-3 polyunsaturated fatty acids (PUFA) after myocardial infarction: results from Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto (GISSI)-Prevenzione Trial. Pharmacoeconomics 2001, 19, (4):411-420.
46. Quilici S, Martin M, McGuire A, Zoellner Y. A cost-effectiveness analysis of n-3 PUFA (Omacor) treatment in post-MI patients. Int J Clin Pract 2006, 60, (8):922-932.
47. Lamotte M, Annemans L, Kawalec P, Zoellner Y. A multi-country health economic evaluation of highly concentrated N-3 polyunsaturated fatty acids in secondary prevention after myocardial infarction. Pharmacoeconomics 2006, 24, (8):783-795.
48. Wei MY, Jacobson TA. Effects of eicosapentaenoic acid versus docosahexaenoic acid on serum lipids: a systematic review and meta-analysis. Curr Atheroscler Rep 2011, 13, (6):474-483.
49. 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.
50. Ishida T, Ohta M, Nakakuki M, et al. 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, 88:281-288.
51. Dawson K, Zhao L, Adkins Y, et al. Modulation of blood cell gene expression by DHA supplementation in hypertriglyceridemic men. J Nutr Biochem 2012, 23, (6):616-621.
52. National Committee for Quality Assurance. Proposed retirement for HEDIS 2015: cholesterol management for patients with cardiovascular conditions (CMC). Available at: http://www.ncqa.org/Portals/0/HomePage/CMC.pdf. Accessed June 8, 2015
53. National Committee for Quality Assurance. Proposed changes to existing measure for HEDIS 2015: comprehensive diabetes care (CDC). Available at: http://www.ncqa.org/Portals/0/HomePage/CDC.pdf. Accessed June 8, 2015
54. National Lipid Association. NLA comments on proposed retirement for HEDIS 2015 with respect to cholesterol management for patients with CVD conditions and diabetes. Available at: https://www.lipid.org/nla/nla-comments-proposed-retirement-hedis-2015-respect-cholesterol-management-patients-cvd. Accessed June 8, 2015
55. Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1—executive summary. J Clin Lipidol 2014, 8:473-488.
56. Stine NW, Chokshi DA. Elimination of lipid levels from quality measures: implications and alternatives. JAMA 2014, 312, (19):1971-1972.
57. International Atherosclerosis Society. An International Atherosclerosis Society position paper: global recommendations for the management of dyslipidemia. Executive summary. Available at: http://www.athero.org/IASPositionPaper.asp. Accessed June 8, 2015
58. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med 2015, 372, (25):2387-2397.
59. Liu J, Sempos CT, Donahue RP, et al. Non-high-density lipoprotein and very-low-density lipoprotein cholesterol and their risk predictive values in coronary heart disease. Am J Cardiol 2006, 98, (10):1363-1368.
60. Boekholdt SM, Arsenault BJ, Mora S, et al. Association of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: a meta-analysis. JAMA 2012, 307, (12):1302-1309.
61. Kastelein JJ, van der Steeg WA, Holme I, et al. Lipids, apolipoproteins, and their ratios in relation to cardiovascular events with statin treatment. Circulation 2008, 117, (23):3002-3009.
62. Toth PP, Grabner M, Punekar RS, et al. Cardiovascular risk in patients achieving low-density lipoprotein cholesterol and particle targets. Atherosclerosis 2014, 235, (2):585-591.
63. Bays HE, Braeckman RA, Ballantyne CM, et al. Icosapent ethyl, a pure EPA omega-3 fatty acid: Effects on lipoprotein particle concentration and size in patients with very high triglyceride levels (the MARINE study). J Clin Lipidol 2012, 6, (6):565-572.
64. Ballantyne CM, Braeckman RA, Bays HE, et al. Effects of icosapent ethyl on lipoprotein particle concentration and size in statin-treated patients with persistent high triglycerides (the ANCHOR Study). J Clin Lipidol 2015, 9, (3):377-383.
65. Rizzo JA, Mallow PJ, Waters HC, Pokrywka GS. Managing to low-density lipoprotein particles compared with low-density lipoprotein cholesterol: a cost-effectiveness analysis. J Clin Lipidol 2013, 7, (6):642-652.
66. Boden WE, Probstfield JL, Anderson T, et al. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med 2011, 365, (24):2255-2267.
67. Wright RS. Recent clinical trials evaluating benefit of drug therapy for modification of HDL cholesterol. Curr Opin Cardiol 2013, 28, (4):389-398.
68. Tanaka N, Ishida T, Nagao M, et al. Administration of high dose eicosapentaenoic acid enhances anti-inflammatory properties of high-density lipoprotein in Japanese patients with dyslipidemia. Atherosclerosis 2014, 237, (2):577-583.
69. Voight BF, Peloso GM, Orho-Melander M, et al. Plasma HDL cholesterol and risk of myocardial infarction: a mendelian randomisation study. Lancet 2012, 380, (9841):572-580.
70. 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.
71. Kris-Etherton PM, Harris WS, Appel LJ. Omega-3 fatty acids and cardiovascular disease: new recommendations from the American Heart Association. Arterioscler Thromb Vasc Biol 2003, 23, (2):151-152.
72. Bradberry JC, Hilleman DE. Overview of omega-3 fatty acid therapies. P&T 2013, 38, (11):681-691.
73. Collins N, Tighe AP, Brunton SA, Kris-Etherton PM. Differences between dietary supplement and prescription drug omega-3 fatty acid formulations: a legislative and regulatory perspective. J Am Coll Nutr 2008, 27, (6):659-666.
74. Lopez JAG, Ito MK. PLA chapter update: prescription fish oil and Blue Cross of Idaho. LipidSpin 2010, 8, (3):32-34.
75. Balk EM, Lichtenstein AH, Chung M, et al. Effects of omega-3 fatty acids on serum markers of cardiovascular disease risk: a systematic review. Atherosclerosis 2006, 189, (1):19-30.
76. Bays H. Fish oils in the treatment of dyslipidemia and cardiovascular disease. In: Kwiterovich PO. The Johns Hopkins Textbook of Dyslipidemia Philadelphia, Pennsylvania: Lippincott Williams & Wolters Kluwer. 2010, 245-257.
77. Calder PC. N-3 fatty acids and cardiovascular disease: evidence explained and mechanisms explored. Clin Sci (Lond) 2004, 107, (1):1-11.
78. 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.
79. Kris-Etherton PM, Harris WS, Appel LJ. Fish consumption, fish oil, omega-3 fatty acids, and cardiovascular disease. Circulation 2002, 106, (21):2747-2757.
80. GISSI Prevenzione Investigators. 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. Lancet 1999, 354, (9177):447-455.
81. GISSI-HF Investigators. 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.
82. Kromhout D, Giltay EJ, Geleijnse JM. N-3 fatty acids and cardiovascular events after myocardial infarction. N Engl J Med 2010, 363, (21):2015-2026.
83. ORIGIN Trial Investigators. N-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med 2012, 367, (4):309-318.
84. Rauch B, Schiele R, Schneider S, et al. 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.
85. Yokoyama M, Origasa H, Matsuzaki M, et al. Effects of eicosapentaenoic acid on major coronary events in hypercholesterolaemic patients (JELIS): a randomised open-label, blinded endpoint analysis. Lancet 2007, 369, (9567):1090-1098.
86. Saito Y, Yokoyama M, Origasa H, et al. 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). Atherosclerosis 2008, 200, (1):135-140.
87. Mozaffarian D, Marchioli R, Macchia A, et al. Fish oil and postoperative atrial fibrillation: the Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) randomized trial. JAMA 2012, 308, (19):2001-2011.
88. 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.
89. Risk and Prevention Study Collaborative Group. N-3 fatty acids in patients with multiple cardiovascular risk factors. N Engl J Med 2013, 368:1800-1808.
90. Matsuzaki M, Yokoyama M, Saito Y, et al. Incremental effects of eicosapentaenoic acid on cardiovascular events in statin-treated patients with coronary artery disease. Circ J 2009, 73, (7):1283-1290.
91. Superko HR, Superko SM, Nasir K, et al. Omega-3 fatty acid blood levels: clinical significance and controversy. Circulation 2013, 128, (19):2154-2161.
92. Masson S, Marchioli R, Mozaffarian D, et al. Plasma n-3 polyun-saturated fatty acids in chronic heart failure in the GISSI-Heart Failure Trial: relation with fish intake, circulating biomarkers, and mortality. Am Heart J 2013, 165, (2):208-215.
93. Itakura H, Yokoyama M, Matsuzaki M, et al. Relationships between plasma fatty acid composition and coronary artery disease. J Atheroscler Thromb 2011, 18, (2):99-107.
94. Rizos EC, Ntzani EE, Bika E, et al. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis. JAMA 2012, 308, (10):1024-1033.
95. Kotwal S, Jun M, Sullivan D, et al. Omega 3 fatty acids and cardiovascular outcomes: systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes 2012, 5, (6):808-818.
96. Kwak SM, Myung SK, Lee YJ, Seo HG. Efficacy of omega-3 fatty acid supplements (eicosapentaenoic acid and docosahexaenoic acid) in the secondary prevention of cardiovascular disease: a meta-analysis of randomized, double-blind, placebo-controlled trials. Arch Intern Med 2012, 172, (9):686-694.
97. Casula M, Soranna D, Catapano AL, Corrao G. Long-term effect of high dose omega-3 fatty acid supplementation for secondary prevention of cardiovascular outcomes: A meta-analysis of randomized, placebo controlled trials [corrected]. Atheroscler Suppl 2013, 14, (2):243-251.
98. Bilato C. N-3 fatty acids and cardiovascular disease: the story is not over yet. Aging Clin Exp Res 2013, 25, (4):357-363.
99. ClinicalTrials.gov. Outcomes Study of Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH). NCT02104817. Available at: http://clinicaltrials.gov/ct2/show/NCT02104817?term=strength+and+omega-3&rank=3. Accessed June 8, 2015
100. ClinicalTrials.gov. A study of AMR101 to evaluate its ability to reduce cardiovascular events in high risk patients with hypertriglyceridemia and on statin (REDUCE-IT). NCT01492361. Available at: http://clinicaltrials.gov/show/NCT01492361. Accessed June 8, 2015