Prescription omega-3 fatty acid products: considerations for patients with diabetes mellitus

References

• Grundy SM Metabolic syndrome pandemic Arterioscler Thromb Vasc Biol 2008 28 4 629 636 18174459
   PubMed Web of Science ®Google Scholar
• Alberti KG Eckel RH Grundy SM Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity Circulation 2009 120 16 1640 1645 19805654
   PubMed Web of Science ®Google Scholar
• Haffner SM Lehto S Ronnemaa T Pyorala K Laakso M Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction N Engl J Med 1998 339 4 229 234 9673301
   PubMed Web of Science ®Google Scholar
• Berglund L Brunzell JD Goldberg AC Evaluation and treatment of hypertriglyceridemia: an endocrine society clinical practice guideline J Clin Endocrinol Metab 2012 97 9 2969 2989 22962670
   PubMed Web of Science ®Google Scholar
• Jorgensen AB Frikke-Schmidt R West AS Grande P Nordestgaard BG Tybjaerg-Hansen A Genetically elevated non-fasting triglycerides and calculated remnant cholesterol as causal risk factors for myocardial infarction Eur Heart J 2013 34 24 1826 1833 23248205
   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 25234560
   PubMed Web of Science ®Google Scholar
• Querton L Buysschaert M Hermans MP Hypertriglyceridemia and residual dyslipidemia in statin-treated, patients with diabetes at the highest risk for cardiovascular disease and achieving very-low low-density lipoprotein-cholesterol levels J Clin Lipidol 2012 6 5 434 442 23009779
   PubMed Web of Science ®Google Scholar
• Fruchart JC Davignon J Hermans MP Residual macrovascular risk in 2013: what have we learned? Cardiovasc Diabetol 2014 13 26 24460800
   PubMed Web of Science ®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 9865671
   PubMedGoogle Scholar
• Pownall HJ Brauchi D Kilinc 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 10217357
   PubMed Web of Science ®Google Scholar
• Davidson MH Stein EA Bays HE 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 17825687
   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 21683321
   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 22819432
   PubMed Web of Science ®Google Scholar
• Kastelein JJP 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 24528690
   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 23998969
   PubMed Web of Science ®Google Scholar
• Garber AJ Abrahamson MJ Barzilay JI Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2016 executive summary Endocr Pract 2016 22 1 84 113 26731084
   PubMed Web of Science ®Google Scholar
• Handelsman Y Bloomgarden ZT Grunberger G American association of clinical endocrinologists and american college of endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan – 2015 Endocr Pract 2015 21 Suppl 1 1 87 25869408
   PubMed Web of Science ®Google Scholar
• American Diabetes Association Standards of medical care in diabetes – 2016 Diabetes Care 2016 39 Suppl 1 S1 S112 26696671
   PubMed Web of Science ®Google Scholar
• Clinical Guidelines Task Force Global guideline for type 2 diabetes Brussels, Belgium International Diabetes Federation 2012
   Google Scholar
• Lovaza [package insert] Research Triangle Park, NC GlaxoSmithKline 2013
   Google Scholar
• Lovaza [package insert] Research Triangle Park, NC GlaxoSmithKline 2014
   Google Scholar
• Vascepa [package insert] Bedminster, NJ Amarin Pharma Inc. 2015
   Google Scholar
• Epanova [package insert] Wilmington, DE AstraZeneca Pharmaceuticals LP 2014
   Google Scholar
• Omtryg [package insert] Arlington, VA Trygg Pharma, Inc. 2014
   Google Scholar
• Hartweg J Perera R Montori V Dinneen S Neil HA Farmer A Omega-3 polyunsaturated fatty acids (PUFA) for type 2 diabetes mellitus Cochrane Database Syst Rev 2008 1 CD003205 18254017
   PubMed Web of Science ®Google Scholar
• Reis CE Landim KC Nunes AC Dullius J Safety in the hypertriglyceridemia treatment with N-3 polyunsaturated fatty acids on glucose metabolism in subjects with type 2 diabetes mellitus Nutr Hosp 2014 31 2 570 576 25617537
   PubMed Web of Science ®Google Scholar
• Akinkuolie AO Ngwa JS Meigs JB Djousse L Omega-3 polyunsaturated fatty acid and insulin sensitivity: a meta-analysis of randomized controlled trials Clin Nutr 2011 30 6 702 707 21959352
   PubMed Web of Science ®Google Scholar
• Brinton EA Ballantyne CM Bays HE Kastelein JJ Braeckman RA Soni PN Effects of icosapent ethyl on lipid and inflammatory para meters in patients with diabetes mellitus-2, residual elevated triglycerides (200–500 mg/dL), and on statin therapy at LDL-C goal: the ANCHOR study Cardiovasc Diabetol 2013 12 100 23835245
   PubMed Web of Science ®Google Scholar
• Amend KL Landon J Thyagarajan V Niemcryk S McAfee A Incidence of hospitalized rhabdomyolysis with statin and fibrate use in an insured US population Ann Pharmacother 2011 45 10 1230 1239 21917557
   PubMed Web of Science ®Google Scholar
• Lopid [package insert] New York, NY Parke-Davis 2010
   Google Scholar
• Niaspan [package insert] North Chicago, IL AbbVie Inc. 2013
   Google Scholar
• Trilipix [package insert] North Chicago, IL AbbVie Inc. 2015
   Google Scholar
• Niaspan [package insert] North Chicago, IL AbbVie Inc. 2015
   Google Scholar
• Capuzzi DM Guyton JR Morgan JM Efficacy and safety of an extended-release niacin (Niaspan): a long-term study Am J Cardiol 1998 82 12A 74U 81U
   PubMed Web of Science ®Google Scholar
• Davidson MH Rosenson RS Maki KC Effects of fenofibric acid on carotid intima-media thickness in patients with mixed dyslipidemia on atorvastatin therapy: randomized, placebo-controlled study (FIRST) Arterioscler Thromb Vasc Biol 2014 34 6 1298 1306 24743431
   PubMed Web of Science ®Google Scholar
• Goldberg AC Bays HE Ballantyne CM Efficacy and safety of ABT-335 (fenofibric acid) in combination with atorvastatin in patients with mixed dyslipidemia Am J Cardiol 2009 103 4 515 522 19195513
   PubMed Web of Science ®Google Scholar
• Jones PH Davidson MH Kashyap ML Efficacy and safety of ABT-335 (fenofibric acid) in combination with rosuvastatin in patients with mixed dyslipidemia: a phase 3 study Atherosclerosis 2009 204 1 208 215 18996523
   PubMed Web of Science ®Google Scholar
• Mohiuddin SM Pepine CJ Kelly MT Efficacy and safety of ABT-335 (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia: a phase 3, randomized, controlled study Am Heart J 2009 157 1 195 203 19081418
   PubMed Web of Science ®Google Scholar
• Braeckman RA Stirtan WG Soni PN Effects of icosapent ethyl (eicosapentaenoic acid ethyl ester) on pharmacokinetic para meters of rosiglitazone in healthy subjects Clin Pharmacol Drug Dev 2015 4 2 143 148 26097794
   PubMed Web of Science ®Google Scholar
• Braeckman RA Stirtan WG Soni PN Effect of concomitant icosapent ethyl (eicosapentaenoic acid ethyl ester) on the pharmacokinetics of atorvastatin Clin Drug Investig 2015 35 1 45 51
   PubMed Web of Science ®Google Scholar
• 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
   Web of Science ®Google Scholar
• 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 24973042
   PubMedGoogle Scholar
• McKenney JM Swearingen D Di Spirito M Study of the pharmacokinetic interaction between simvastatin and prescription omega-3-acid ethyl esters J Clin Pharmacol 2006 46 7 785 791 16809804
   PubMed Web of Science ®Google Scholar
• Gosai P Liu J Doyle RT 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 19006471
   PubMed Web of Science ®Google Scholar
• Di Spirito M Morelli G Doyle RT Johnson J McKenney J 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 19006470
   PubMed Web of Science ®Google Scholar
• Bays HE Safety considerations with omega-3 fatty acid therapy Am J Cardiol 2007 99 6A 35C 43C
   PubMed Web of Science ®Google Scholar
• Harris WS Expert opinion: omega-3 fatty acids and bleeding-cause for concern? Am J Cardiol 2007 99 6A 44C 46C
   PubMed Web of Science ®Google Scholar
• 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 24472372
   PubMed Web of Science ®Google Scholar
• Bradberry JC Hilleman DE Overview of omega-3 fatty acid therapies P T 2013 38 11 681 691 24391388
   PubMedGoogle Scholar
• 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 19155425
   PubMed Web of Science ®Google Scholar
• Lopez JA Ito MK PLA chapter update: prescription fish oil and Blue Cross of Idaho LipidSpin 2010 8 3 32 34
   Google Scholar
• Kleiner AC Cladis DP Santerre CR A comparison of actual versus stated label amounts of EPA and DHA in commercial omega-3 dietary supplements in the United States J Sci Food Agric 2015 95 6 1260 1267 25044306
   PubMed Web of Science ®Google Scholar
• Albert BB Derraik JG Cameron-Smith D Fish oil supplements in New Zealand are highly oxidised and do not meet label content of n-3 PUFA Sci Rep 2015 5 7928 25604397
   PubMed Web of Science ®Google Scholar
• Ritter JC Budge SM Jovica F Quality analysis of commercial fish oil preparations J Sci Food Agric 2013 93 8 1935 1939 23255124
   PubMed Web of Science ®Google Scholar
• Shim SM Santerre CR Burgess JR Deardorff DC Omega-3 fatty acids and total polychlorinated biphenyls in 26 dietary supplements J Food Sci 2003 68 8 2436 2440
   Web of Science ®Google Scholar
• American Cancer Society Dietary supplements: what is safe? American Cancer Society 2015 Available from: http://www.cancer.org/acs/groups/cid/documents/webcontent/002385-pdf.pdf Accessed March 2, 2016
   Google Scholar
• health.gov [homepage on the Internet] Regulatory information: Dietary supplement health and education act of 1994 Food and Drug Administration Available from: http://health.gov/dietsupp/ch1.htm Accessed March 2, 2016
   Google Scholar
• Cohen PA Hazards of hindsight – monitoring the safety of nutritional supplements N Engl J Med 2014 370 14 1277 1280 24693886
   PubMed Web of Science ®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 21787228
   PubMed Web of Science ®Google Scholar
• ORIGIN Trial Investigators Bosch J Gerstein HC n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia N Engl J Med 2012 367 4 309 318 22686415
   PubMed Web of Science ®Google Scholar
• American Diabetes Association Standards of medical care in diabetes – 2015 Diabetes Care 2015 38 Suppl 1 S1 S93
   PubMed Web of Science ®Google Scholar
• Expert Dyslipidemia Panel of the International Atherosclerosis Society Panel members An International Atherosclerosis Society Position Paper: global recommendations for the management of dyslipidemia – full report J Clin Lipidol 2014 8 1 29 60 24528685
   PubMed 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 22264569
   PubMed Web of Science ®Google Scholar
• Nieman K Dicklin M Bell M Rains T Maki K Relationship between baseline triglyceride concentration and triglyceride reduction with 4 g/d long-chain omega-3 acid ethyl esters (1035.6) FASEB J 2014 28 1 Suppl 1035 6 24578136
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration Omtryg Medical Reviews. Food and Drug Administration; 2014 Center for Drug Evaluation and Research Available from: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204977Orig1s000MedR.pdf Accessed March 2, 2016
   Google Scholar
• 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 21975919
   PubMed Web of Science ®Google 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 23375839
   PubMed Web of Science ®Google Scholar
• Dawson K Zhao L Adkins Y Modulation of blood cell gene expression by DHA supplementation in hypertriglyceridemic men J Nutr Biochem 2012 23 6 616 621 21775114
   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 23325450
   PubMed Web of Science ®Google Scholar
• Braeckman RA Bays HE Ballantyne CM Stirtan WG Soni PN harmacokinetic and triglyceride-lowering pharmacodynamic effects of icosapent ethyl (eicosapentaenoic acid ethyl ester) across clinical studies Poster presented at: Annual Scientific Sessions of the American Heart Association November 16–20; 2013 Dallas, TX
   Google Scholar
• Bays HE Ballantyne CM Braeckman RA Icosapent ethyl (eicosapentaenoic acid ethyl ester): effects upon high-sensitivity C-reactive protein and lipid parameters in patients with metabolic syndrome Metab Syndr Relat Disord 2015 13 6 239 247 25893544
   PubMed Web of Science ®Google Scholar
• Hassan A Tajuddin N Shaikh A Retrospective case series of patients with diabetes or prediabetes who were switched from omega-3-acid ethyl esters to icosapent ethyl Cardiol Ther 2015 4 1 83 93 25515964
   PubMed Web of Science ®Google Scholar
• Risk and Prevention Study Collaborative Group n-3 fatty acids in patients with multiple cardiovascular risk factors N Engl J Med 2013 368 19 1800 1808 23656645
   PubMed Web of Science ®Google Scholar
• Yokoyama M Origasa H JELIS Investigators Effects of eicosapentaenoic acid on cardiovascular events in Japanese patients with hypercholesterolemia: rationale, design, and baseline characteristics of the Japan EPA Lipid Intervention Study (JELIS) Am Heart J 2003 146 4 613 620 14564313
   PubMed Web of Science ®Google Scholar
• Yokoyama M Origasa H Matsuzaki M 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 17398308
   PubMed Web of Science ®Google Scholar
• Saito Y Yokoyama M Origasa H 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 18667204
   PubMed Web of Science ®Google Scholar
• Oikawa S Yokoyama M Origasa H 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 2009 206 2 535 539 19447387
   PubMed Web of Science ®Google Scholar
• University of Oxford ASCEND: a study of cardiovascular events in diabetes Available from: http://clinicaltrials.gov/ct2/show/NCT00135226?term=00135226&rank=1. NLM identifier: NCT00135226 Accessed March 2, 2016
   Google Scholar
• AstraZeneca Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH) Available from: http://clinicaltrials.gov/ct2/show/NCT02104817?term=strength+and+omega-3&rank=3. NLM identifier: NCT02104817 Accessed March 2, 2016
   Google Scholar
• Amarin Pharma Inc. A study of AMR101 to evaluate its ability to reduce cardiovascular events in high risk patients with hypertriglyceridemia and on statin (REDUCE-IT) Available from: http://clinicaltrials.gov/show/NCT01492361. NLM identifier: NCT01492361 Accessed March 2, 2016
   Google Scholar
• Cannon CP Blazing MA Giugliano RP Ezetimibe added to statin therapy after acute coronary syndromes N Engl J Med 2015 372 25 2387 2397 26039521
   PubMed Web of Science ®Google Scholar
• Sabatine MS Giugliano RP Wiviott SD Efficacy and safety of evolocumab in reducing lipids and cardiovascular events N Engl J Med 2015 372 16 1500 1509 25773607
   PubMed Web of Science ®Google Scholar
• Robinson JG Farnier M Krempf M Efficacy and safety of alirocumab in reducing lipids and cardiovascular events N Engl J Med 2015 372 16 1489 1499 25773378
   PubMed Web of Science ®Google Scholar