166
Views
8
CrossRef citations to date
0
Altmetric
Clinical Trial Report

A new pure ω-3 eicosapentaenoic acid ethyl ester (AMR101) for the management of hypertriglyceridemia: the MARINE trial

Pages 687-695 | Published online: 10 Jan 2014

References

  • Cohen JD, Cziraky MJ, Cai Q et al. 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. 106(7), 969–975 (2010).
  • Ford ES, Li C, Zhao G, Pearson WS, Mokdad AH. Hypertriglyceridemia and its pharmacologic treatment among US adults. Arch. Intern. Med. 169(6), 572–578 (2009).
  • Miller M, Stone NJ, Ballantyne C et al.; 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, and Council on the Kidney in Cardiovascular Disease. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation 123(20), 2292–2333 (2011).
  • Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the 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). JAMA 285, 2486–2497 (2001).
  • Christian JB, Bourgeois N, Snipes R, Lowe KA. Prevalence of severe (500 to 2,000 mg/dl) hypertriglyceridemia in United States adults. Am. J. Cardiol. 107(6), 891–897 (2011).
  • Davidson MH, Stein EA, Bays HE et al.; 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. 29(7), 1354–1367 (2007).
  • 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 189(1), 19–30 (2006).
  • Bays H. Fish oils in the treatment of dyslipidemia and cardiovascular disease. In: The Johns Hopkins Textbook of Dyslipidemia. Kwiterovich PO (Ed.). Lippincott Williams & Wolters Kluwer, PA, USA, 245–257 (2010).
  • Harris WS. n-3 fatty acids and serum lipoproteins: human studies. Am. J. Clin. Nutr. 65(5 Suppl), 1645S–1654S (1997).
  • Maki KC, Dicklin MR, Davidson MH, Doyle RT, Ballantyne CM; COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators. Baseline lipoprotein lipids and low-density lipoprotein cholesterol response to prescription omega-3 acid ethyl ester added to Simvastatin therapy. Am. J. Cardiol. 105(10), 1409–1412 (2010).
  • Pownall HJ, Brauchi D, Kilinç 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 143(2), 285–297 (1999).
  • Wei MY, Jacobson TA. Effects of eicosapentaenoic acid versus docosahexaenoic acid on serum lipids: a systematic review and meta-analysis. Curr. Atheroscler. Rep. 13(6), 474–483 (2011).
  • Grimsgaard S, Bonaa KH, Hansen JB, Nordøy A. Highly purified eicosapentaenoic acid and docosahexaenoic acid in humans have similar triacylglycerol-lowering effects but divergent effects on serum fatty acids. Am. J. Clin. Nutr. 66(3), 649–659 (1997).
  • Nestel P, Shige H, Pomeroy S, Cehun M, Abbey M, Raederstorff D. The n-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid increase systemic arterial compliance in humans. Am. J. Clin. Nutr. 76(2), 326–330 (2002).
  • Ando M, Sanaka T, Nihei H. Eicosapentanoic acid reduces plasma levels of remnant lipoproteins and prevents in vivo peroxidation of LDL in dialysis patients. J. Am. Soc. Nephrol. 10(10), 2177–2184 (1999).
  • Kurabayashi T, Okada M, Tanaka K. Eicosapentaenoic acid effect on hyperlipidemia in menopausal Japanese women. The Niigata Epadel Study Group. Obstet. Gynecol. 96(4), 521–528 (2000).
  • Schaefer EJ, Asztalos IB, Gleason JA et al. Effects of eicosapentaenoic acid, docosahexaenoic acid, and olive oil on cardiovascular disease risk factors. Circulation 122, Abstract 20007 (2010).
  • Mori TA, Burke V, Puddey IB et al. Purified eicosapentaenoic and docosahexaenoic acids have differential effects on serum lipids and lipoproteins, LDL particle size, glucose, and insulin in mildly hyperlipidemic men. Am. J. Clin. Nutr. 71(5), 1085–1094 (2000).
  • 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. 108(5), 682–690 (2011).
  • Bays HE, Ballantyne CM, Kastelein JJ et al. AMR101, a pure-EPA omega-3 fatty acid, lowers triglycerides in patients with very high triglycerides without raising LDL-C: the MARINE study. Eur. Heart J. 32(Suppl. 1), 342 (2011).
  • Braeckman RA, Manku MS, Bays HE et al. Effects of AMR101, a pure EPA omega-3 fatty acid, on the fatty acid profile in plasma and red blood cells in patients with very high triglycerides (results from the MARINE trial). Eur. Heart J. 32(Suppl. 1), 510–511 (2011).
  • Bays HE, Braeckman RA, Ballantyne CM et al. Effects of AMR101, a pure ethyl eicosapentaenoic acid omega-3 fatty acid, on lipoprotein particle concentration and size in patients with very high triglycerides (the MARINE study). Circulation 124, Abstract A14232 (2011).
  • Ballantyne CM, Bays HE, Kastelein JJ et al. AMR101 lowers triglycerides, atherogenic lipoprotein, phospholipase A2, and high-sensitivity C-reactive protein levels in patients with high triglycerides and on background statin therapy (the ANCHOR study). Circulation 124, Abstract A15071 (2011).
  • 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. 6(1), 5–18 (2012).
  • Schaefer EJ, Asztalos IB, Gleason JA et al. Effects of eicosapentaenoic acid, docosahexaenoic acid, and olive oil on cardiovascular disease risk factors. American Heart Association, Washington, DC, USA, 25–28 April 2010.
  • Robinson JG, Wang S, Smith BJ, Jacobson TA. Meta-analysis of the relationship between non-high-density lipoprotein cholesterol reduction and coronary heart disease risk. J. Am. Coll. Cardiol. 53(4), 316–322 (2009).
  • Itakura H, Yokoyama M, Matsuzaki M et al.; JELIS Investigators. Relationships between plasma fatty acid composition and coronary artery disease. J. Atheroscler. Thromb. 18(2), 99–107 (2011).
  • James MJ, Gibson RA, Cleland LG. Dietary polyunsaturated fatty acids and inflammatory mediator production. Am. J. Clin. Nutr. 71(1 Suppl), 343S–348S (2000).
  • Goldberg AC, Schonfeld G, Feldman EB et al. Fenofibrate for the treatment of type IV and V hyperlipoproteinemias: a double-blind, placebo-controlled multicenter US study. Clin. Ther. 11(1), 69–83 (1989).
  • Satoh N, Shimatsu A, Kotani K et al. Purified eicosapentaenoic acid reduces small dense LDL, remnant lipoprotein particles, and C-reactive protein in metabolic syndrome. Diabetes Care 30(1), 144–146 (2007).
  • Keech A, Simes RJ, Barter P et al.; FIELD study investigators. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with Type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet 366(9500), 1849–1861 (2005).
  • Ginsberg HN, Elam MB, Lovato LC et al.; ACCORD Study Group. Effects of combination lipid therapy in Type 2 diabetes mellitus. N. Engl. J. Med. 362(17), 1563–1574 (2010).
  • Scott R, O’Brien R, Fulcher G et al.; Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study Investigators. Effects of fenofibrate treatment on cardiovascular disease risk in 9,795 individuals with Type 2 diabetes and various components of the metabolic syndrome: the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Diabetes Care 32(3), 493–498 (2009).
  • Boden WE, Probstfield JL, Anderson T et al.; AIM-HIGH Investigators. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N. Engl. J. Med. 365(24), 2255–2267 (2011).
  • Yokoyama M, Origasa H, Matsuzaki M et al.; 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. Lancet 369(9567), 1090–1098 (2007).
  • Tanaka K, Ishikawa Y, Yokoyama M et al.; JELIS Investigators, Japan. Reduction in the recurrence of stroke by eicosapentaenoic acid for hypercholesterolemic patients: subanalysis of the JELIS trial. Stroke. 39(7), 2052–2058 (2008).
  • Saito Y, Yokoyama M, Origasa H et al.; 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). Atherosclerosis 200(1), 135–140 (2008).
  • Matsuzaki M, Yokoyama M, Saito Y et al.; JELIS Investigators. Incremental effects of eicosapentaenoic acid on cardiovascular events in statin-treated patients with coronary artery disease. Circ. J. 73(7), 1283–1290 (2009).
  • Oikawa S, Yokoyama M, Origasa H et al.; JELIS Investigators, Japan. Suppressive effect of EPA on the incidence of coronary events in hypercholesterolemia with impaired glucose metabolism: sub-analysis of the Japan EPA Lipid Intervention Study (JELIS). Atherosclerosis 206(2), 535–539 (2009).
  • Jacobson TA. Beyond lipids: the role of omega-3 fatty acids from fish oil in the prevention of coronary heart disease. Curr. Atheroscler. Rep. 9(2), 145–153 (2007).
  • 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 354, 447–455 (1999).
  • Bacova B, Radosinska J, Knezl V et al. Omega-3 fatty acids and atorvastatin suppress ventricular fibrillation inducibility in hypertriglyceridemic rat hearts: implication of intracellular coupling protein, connexin-43. J. Physiol. Pharmacol. 61(6), 717–723 (2010).
  • Rupp H. Omacor (prescription omega-3-acid ethyl esters 90): from severe rhythm disorders to hypertriglyceridemia. Adv. Ther. 26(7), 675–690 (2009).
  • 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 372, 1223–1230 (2008).
  • GISSI-HF Investigators. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial. Lancet 372, 1231–1239 (2008).
  • Rauch B, Schiele R, Schneider S et al.; 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 122(21), 2152–2159 (2010).
  • Kromhout D, Giltay EJ, Geleijnse JM; Alpha Omega Trial Group. n-3 fatty acids and cardiovascular events after myocardial infarction. N. Engl. J. Med. 363(21), 2015–2026 (2010).
  • 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. 6(3), 391–409 (2008).

Website

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.