Selecting an Omega-3 Product for Therapeutic Use: An Opportunity to Educate Patients

DECEMBER 21, 2016
Sponsored by Amarin Pharma, Inc.



UNMET NEEDS IN THE MANAGEMENT OF DYSLIPIDEMIA
Statins are the gold standard in the management of dyslipidemia, due to accumulated evidence supporting their efficacy in lowering low-density lipoprotein cholesterol (LDL-C) levels and reducing atherosclerotic cardiovascular risk.1,2 However, despite the effectiveness of statins in terms of LDL-C lowering, residual risk of cardiovascular events remains.3-10 Addressing this residual cardiovascular risk represents an important unmet need.11 After initiating statin therapy, many physicians treat dyslipidemia further by next targeting triglycerides.

Managing Elevated Triglycerides
Omega-3 fatty acids are a popular therapeutic option for reducing triglyceride levels.12,13 Although omega-3 fatty acids are present in nonprescription fish oil dietary supplements, as well as in refined prescription omega-3 products, patients may not be aware of the important differences between fish oil dietary supplements and prescription omega-3 products.11,12,14 Pharmacists can educate their patients on these important differences and provide guidance regarding appropriate selection of available products.14

Omega-3 Fatty Acids: Benefits and Sources
Fish oil contains omega-3 fatty acids, such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are the most studied forms of omega-3 fatty acids.12,13 Both EPA and DHA lower serum triglycerides; however, DHA has been shown to raise LDL-C levels in some patients and EPA has been shown to have a neutral effect on LDL-C levels.12,15

EPA and DHA are present in FDA-approved prescription products, all of which contain purified forms of these omega-3 fatty acids. However, only VASCEPA® (icosapent ethyl) is a pure EPA product.16 Lovaza (omega-3-acid ethyl esters) and its generic equivalents contain a mixture of EPA and DHA.17 Additionally, Lovaza is only partially purified and contains other non–omega-3 components, some of which have not been characterized.18

Prescription and OTC products are different than dietary supplements. Dietary supplements are regulated as food, not as FDA-approved drugs.14 The FDA does not require dietary supplements to demonstrate safety and efficacy in clinical trials, and, as noted by the FDA, they are not intended to diagnose, treat, cure, or prevent any disease.14,19 More than 350 nonprescription fish oil dietary supplements are available; these products contain EPA, DHA, saturated fats, and other ingredients.11,20

ABOUT VASCEPA
VASCEPA is an ethyl ester of EPA that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, and it is the first nonstatin, prescription omega-3 fatty acid shown to reduce triglyceride levels without increasing LDL-C levels.15-17,21 Each 1-g capsule of VASCEPA contains 1 g of EPA; the capsules do not contain DHA.16 VASCEPA is also the first and only prescription omega-3 that is available as a 0.5-g capsule for patients who need or prefer a smaller dosing option.16

DIFFERENCES BETWEEN PRESCRIPTION PRODUCTS AND NONPRESCRIPTION DIETARY SUPPLEMENTS
Variations in the composition and quality of fish oil supplements may present a barrier to achieving therapeutic goals.11 Typically, fish oil supplements have a low concentration of active ingredients, with an EPA concentration of 18% and a DHA concentration of 12%. Undisclosed impurities, saturated fats, and different omega mixtures in typical fish oil supplements account for 70% of the product composition.22,23 To achieve dose equivalence of 4 g per day of prescription EPA, patients need to take at least 20 1-g units of a fish oil supplement with 18% EPA to attempt to receive the amount of EPA in a daily dose of VASCEPA.16

In addition to potency, quality may be an important factor in product selection. Fish oils, like all supplements, are not regulated as thoroughly as prescription products. The lack of rigorous oversight by the FDA may result in a less consistent batch-to-batch quality and/or contamination.24 Unlike dietary supplements, prescription omega-3 products are subject to stringent FDA regulatory oversight and provide reliable and consistent quality.11,14

Prescription omega-3 products have proven safety, lipid-lowering efficacy and can be prescribed with confidence to patients with elevated triglycerides, including those who are already taking a statin.11,14 These prescription products provide patients with a reliable and consistent source of omega-3 fatty acids that helps patients to achieve therapeutic goals without the uncertainties or pill burden concerns of fish oil supplements.11,14



ROLE OF THE PHARMACIST
Fish oil products are among the most frequently consumed dietary supplements in the United States. In fact, consumption has increased nearly 10-fold over the past decade.25 As one of the most trusted health care providers, pharmacists are in a good position to provide patients with information regarding omega-3 fatty acid products. Pharmacists can educate patients about their choices and explain the differences between prescription omega-3 products and fish oil supplements.14 For patients receiving treatment to address a medical condition, only a prescription omega-3 product is appropriate, as fish oil dietary supplements are not intended for that purpose. The appropriate use of a prescription product, such as VASCEPA, can help patients achieve lower triglyceride levels.14,16 There is also a savings program that can lower commercial patients' out-of-pocket cost to as little as $9.

References
  1. Lloyd-Jones DM, Morris PB, Ballantyne CM, et al. 2016 ACC expert consensus decision pathway on the role of non-statin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol. 2016;68(1):92-125. doi: 10.1016/j.jacc.2016.03.519.
  2. Jacobson TA, Ito MK, Maki KC, et al. National lipid association recommendations for patient-centered management of dyslipidemia: part 1--full report. J Clin Lipidol. 2015;9(2):129-169. doi: 10.1016/j.jacl.2015.02.003.
  3. Shepherd J, Cobbe SM, Ford I, et al; West of Scotland Coronary Prevention Study Group. Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. N Engl J Med. 1995;333(20):1301-1307.
  4. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). Lancet. 1994;344(8934):1383-1389.
  5. Ballantyne CM. Low-density lipoproteins and risk for coronary artery disease. Am J Cardiol. 1998;82(9A):3Q-12Q.
  6. Sacks FM, Pfeffer MA, Moye LA, et al; Cholesterol and Recurrent Events Trial Investigators. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med. 1996;335(14):1001-1009.
  7. Downs JR, Clearfield M, Weis S, et al. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study. JAMA. 1998;279(20):1615-1622.
  8. Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998;339(19):1349-1357.
  9. Brown BG. Maximizing coronary disease risk reduction using nicotinic acid combined with LDL-lowering therapy. Eur Heart J Suppl. 2005;7(suppl F):F34-F40.
  10. Grundy SM, Cleeman JI, Merz CN, et al; National Heart, Lung, and Blood Institute; American College of Cardiology Foundation; American Heart Association. Implications of recent clinical trials for National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation. 2004;110(2):227-239.
  11. Fialkow J. Omega-3 fatty acid formulations in cardiovascular disease: dietary supplements are not substitutes for prescription products. Am J Cardiovasc Drugs. 2016;16(4):229-239. doi: 10.1007/s40256-016-0170-7.
  12. 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. doi: 10.1007/s11883-011-0210-3.
  13. 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; 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. doi: 10.1161/CIR.0b013e3182160726.
  14. Hilleman D, Smer A. Prescription omega-3 fatty acid products and dietary supplements are not interchangeable. Manag Care. 2016;25(1):46-52.
  15. 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. doi: 10.1016/j.jacl.2011.10.018.
  16. Vascepa [prescribing information]. Bedminster, NJ: Amarin Pharma, Inc; 2016.
  17. Lovaza [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; 2015.
  18. US Food and Drug Administration. Citizen petition denial response from FDA/CDER to Crowell & Moring LLP. Regulations.gov website. regulations.gov/document?D=FDA-2013-P-0148-0006. Published February 21, 2014. Accessed November 8, 2016.
  19. Questions and answers on dietary supplements. FDA website. fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm480069.htm. Updated January 13, 2016. Accessed November 8, 2016.
  20. Dietary Supplement Label Database: Omega-3 results. National Institutes of Health website. https://www.dsld.nlm.nih.gov/dsld/rptQSearch.jsp?item=omega-3&db=adsld. Accessed October 4, 2016.
  21. 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. doi: 10.1016/j.amjcard.2011.04.015.
  22. Davidson MH. Omega-3 fatty acids: new insights into the pharmacology and biology of docosahexaenoic acid, docosapentaenoic acid, and eicosapentaenoic acid. Curr Opin Lipidol. 2013;24(6):467-474. doi: 10.1097/MOL.0000000000000019.
  23. 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. doi: 10.1089/met.2011.0004.
  24. New York Attorney General Targets Supplements at Major Retailers. New York Times website. well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/?_r=0. Published February 3, 2015. Accessed November 29, 2016.
  25. Kantor ED, Rehm CD, Du M, White E, Giovannucci EL. Trends in dietary supplement use among US adults from 1999-2012. JAMA. 2016;316(14):1464-1474. doi: 10.1001/jama.2016.14403.

Indication and Limitations of Use
VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
  • The effect of VASCEPA on cardiovascular mortality and morbidity or on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information for VASCEPA
  • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
  • Use with caution in patients with known hypersensitivity to fish and/or shellfish.
  • The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% VASCEPA, 1.0% placebo).
  • Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
  • In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
  • Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
  • Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.

See full Prescribing Information for more information on VASCEPA.
 
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