VASCEPA is icosapent ethyl (IPE), the only EPA approved to significantly reduce CV risk1,2

Fenofibrates with statins: No proven CV risk reduction3

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In 2015, the FDA withdrew approval for fenofibrates and niacin in combination with statins, based upon data from 3 trials,* finding3:

  • Using fenofibrates or niacin in combination with a statin failed to show additional CV benefit
  • The benefits no longer outweighed the various risks

Not recommended by the ADA4

  • According to the 2019 ADA Standards of Medical Care in Diabetes, combination therapy (statin/fibrate) has not been shown to improve atherosclerotic cardiovascular disease outcomes and is generally not recommended
  • No proven CV benefit

Patients may be paying more than you think for fenofibrates

  • The average out-of-pocket cost of fenofibrates for patients with commercial insurance in Q4 2019: $17.91

Fenofibrates and niacin are not FDA approved for co-administration with statins to affect lipid, lipoprotein, or inflammation parameters with the aim of reducing CV mortality or morbidity.

Cross-trial comparisons are subject to differences in populations, primary outcomes, and other trial design aspects.

No head-to-head, randomized, well-controlled studies have been conducted to compare the effects of VASCEPA with other FDA-approved therapies.

VASCEPA is IPE, the only FDA-approved EPA1

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Unlike VASCEPA, Lovaza® (omega-3-acid ethyl esters) contains both EPA and DHA, which may raise LDL-C

This chart contains FDA-approved prescription product information related to patients with very high triglycerides taking 4 grams per day.

  • 5 trials in the omega-3 class, including ORIGIN, Risk and Prevention Study, OMEGA, ASCEND, and VITAL, that studied fish oil or mixtures of omega-3 fatty acids that include DHA have failed to demonstrate an impact on cardiovascular events11-15
  • CV outcomes studies of earlier-generation drug therapies, including prescription omega-3 mixture products containing DHA, have failed to demonstrate CV benefit on top of statins11-15

Lovaza is not AB-rated to prescription VASCEPA16

No head-to-head trials have been conducted between VASCEPA and Lovaza.

Cross-trial comparisons are subject to differences in populations, primary outcomes, and other trial design aspects.

DHA-containing products are not FDA approved for co-administration with statins to affect lipid, lipoprotein, or inflammation parameters with the aim of reducing CV mortality or morbidity.

VASCEPA may be affordable for most patients

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Fish oil dietary supplements: Not intended nor proven to treat, cure, or prevent any disease17

CV outcomes are missing

  • Fish oil dietary supplements are not required to demonstrate efficacy or safety prior to being marketed, and they have repeatedly failed to demonstrate CV benefit in previous trials11-13,18
  • In 2019, the FDA concluded that evidence used to support CV claims for fish oil dietary supplements was inconclusive and highly inconsistent19

Rx designation is missing

  • Fish oil dietary supplements do not have to meet strict FDA standards for prescription drug approval and are not FDA approved to treat any medical conditions17,18

Consistent composition is missing

  • Fish oil dietary supplements are regulated as food, not drugs, and frequently vary in actual DHA and EPA content and composition20
  • Can contain up to 36% saturated fats and oxidized lipids21-23

Stability is missing

  • Omega-3 fatty acids can be easily oxidized or damaged21
  • Unlike fish oil dietary supplements, VASCEPA is expertly manufactured and encapsulated to ensure stability
  • Demonstrated multi-year stability with consistent reproducibility

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IMPORTANT SAFETY INFORMATION

VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components

VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter

It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur

INDICATIONS AND LIMITATIONS OF USE

VASCEPA® (icosapent ethyl) is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease

VASCEPA is indicated as an adjunct to diet to reduce TG levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin

Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%) and atrial fibrillation (5% vs 4%)

Common adverse reactions in the hypertriglyceridemia trials (incidence ≥1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%)

Adverse Events, Product Complaints, or Special Situations may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088

Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding

Please see full Prescribing Information for more information on VASCEPA.

EPA=eicosapentaenoic acid.

*ACCORD-Lipid, AIM-HIGH, and HPS2-Thrive.

Data on file.

Source: Symphony Health Claims Data; March 2020.

§DHA-containing products may raise LDL-C in patients with elevated TG levels.

References: 1. VASCEPA [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019. 2. Lovaza [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2019. 3. Department of Health and Human Services. [Docket no. FDA–2016–N–1127]: AbbVie Inc., et al; Withdrawal of approval of indications related to the coadministration with statins in applications for niacin extended-release tablets and fenofibric acid delayed-release capsules. Federal Register. April 18, 2016;81(74):22612-22613. 4. American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2019. Diabetes Care. 2019;42(suppl 1):S103-S123. https://via.hypothes.is/https://care.diabetesjournals.org/content/42/Supplement_1/S103#annotations:JHhz_lCrEembFJ9LIVBZIw. 5. 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. 6. Megaza [package insert]. Bengaluru, India: Strides Shasun Limited; 2016. 7. Omega-3-acid ethyl esters [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2019. 8. Omega-3-acid ethyl esters [package insert]. Chestnut Ridge, NY: Par Pharmaceutical, Inc.; 2017. 9. Omega-3-acid ethyl esters [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; 2019. 10. Omega-3-acid ethyl esters [package insert]. Weston, FL: Apotex Corp.; 2019. 11. ORIGIN Trial Investigators; Bosch J, Gerstein HC, Dagenais GR, et al. n–3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012;367(4):309-318. 12. 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. 13. Rauch B, Schiele R, Schneider S, et al; for the 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. 14. ASCEND Study Collaborative Group; Bowman L, Mafham M, Wallendszus K, et al. Effects of n−3 Fatty Acid Supplements in Diabetes Mellitus. N Engl J Med. 2018;379(16):1540-1550. 15. Manson JE, Cook NR, Lee IM, et al. Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease. N Engl J Med. 2019;380(1):33-44. 16. US Department of Health and Human Services. Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). 37th ed. Washington, DC: US Dept of Health and Human Services; 2017. 17. US Food and Drug Administration. Food facts: Dietary supplements. https://www.fda.gov/media/79995/download. Accessed February 26, 2020. 18. Hilleman D, Smer A. Prescription omega-3 fatty acid products and dietary supplements are not interchangeable. Manag Care. 2016;25(1):46-52. 19. US Food and Drug Administration. FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease. https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-new-qualified-health-claims-epa-and-dha-omega-3-consumption-and-risk-hypertension-and. Accessed March 23, 2019. 20. 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. 21. Mason RP, Sherratt SC. Omega-3 fatty acid fish oil dietary supplements contain saturated fats and oxidized lipids that may interfere with their intended biological benefits. Biochem Biophys Res Commun. 2017;483(1):425-429. 22. US Food and Drug Administration. Letter responding to health claim petition dated June 23, 2003 (wellness petition): omega-3 fatty acids and reduced risk of coronary heart disease (docket no. 2003Q-0401). http://wayback.archive-it.org/7993/20171114183726/https://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm072936.htm. Published September 8, 2004. Accessed February 27, 2020. 23. Department of Health and Human Services. [Docket no. FDA–2016–N–1127]: AbbVie Inc., et al; Withdrawal of approval of indications related to the coadministration with statins in applications for niacin extended-release tablets and fenofibric acid delayed-release capsules. Federal Register. April 18, 2016;81(74):22612-22613.