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

Unlike VASCEPA, Lovaza® (omega-3-acid ethyl esters) contains both EPA and DHA, which may raise LDL-C1,2:

  • CV outcomes studies of earlier generation drug therapies, including omega-3 mixture products containing DHA, have failed to demonstrate CV benefit on top of statins3-7
  • 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 events3-7

Lovaza is not AB-rated to prescription VASCEPA8

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

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.

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The FDA reconsidered fenofibrates with statins.9
And you should, too.

Graphic icon reading No Additional CV Benefit
  • The ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE studies of fenofibrates and niacin10-12:
    • Failed to demonstrate incremental CV benefit when a fenofibrate or niacin was added to a statin
    • Evaluated the impact of adding a second lipid-lowering therapy on CV outcomes. Although not designed to test the effect of lowering TG levels in patients with high levels after statin therapy, each failed to demonstrate any incremental CV benefit of adding a second lipid-altering drug, despite raising HDL-C and reducing TG levels among statin-treated patients with well-controlled LDL-C
Graphic icon with exclamation point
  • In 2015, the FDA withdrew approval for fenofibrates and niacin in combination with statins, based upon data from the 3 trials, finding the benefits no longer outweighed the various risks9
Graphic icon with up arrow reading LDL-C
  • Impact of fenofibrate on lipids in statin-treated patients as compared to placebo:
    • Blunted statins’ LDL-C lowering effect in patients with high TG on a moderate- or high-intensity statin13-15
    • Significantly raised LDL-C in patients with very high TG (≥500 mg/dL)16

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 TG-lowering therapies.

 

Combination therapy (statin/fibrate) has not been shown to improve atherosclerotic cardiovascular disease outcomes and is generally not recommended, per the ADA 2019 Standards of Medical Care in Diabetes17

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Fish oil dietary supplements: Neither intended nor proven to treat medical conditions

Statin-treated patients remain at high risk for CV disease and require proven prescription treatment.18 When VASCEPA is replaced with fish oil dietary supplements, patients don't get critical CV risk reduction benefits

  • CV outcomes are missing—Fish oil dietary supplements are not required to demonstrate efficacy or safety prior to being marketed, and they have failed to demonstrate CV benefit in previous trials3-5,19
  • Rx designation is missing—Fish oil dietary supplements do not have to meet strict FDA standards for Rx drug approval and are not FDA approved to treat any medical conditions19,20
  • Content consistency is missing—Actual omega-3 content for fish oil dietary supplements may not match the amount advertised on the label21

Neither fish oil dietary supplements nor other omega-3 dietary supplements are an alternative to VASCEPA. Supplements are not intended to treat, cure, or prevent any disease.

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VASCEPA has a well-established safety profile

LEARN MORE
 

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

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
  • 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 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 for bleeding should be monitored

Please see full Prescribing Information for more information on VASCEPA.


References: 1. VASCEPA [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019. 2. Lovaza [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2019. 3. 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. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. ACCORD Study Group; Ginsberg HN, Elam MB, Lovato LC, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med. 2010;362(17):1563-1574. 11. AIM-HIGH Investigators. Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy. N Engl J Med. 2011;365(24):2255-2267. 12. HPS2-THRIVE Collaborative Group. Effects of extended-release niacin with laropiprant in high-risk patients. N Engl J Med. 2014;371(3):203-212. 13. Davidson MH, Rosenson RS, Maki KC, et al. 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. 14. Ouwens MJ, Nauta J, Ansquer JC, Driessen S. Systematic literature review and meta-analysis of dual therapy with fenofibrate or fenofibric acid and a statin versus a double or equivalent dose of statin monotherapy. Curr Med Res Opin. 2015;31(12):2273-2285. 15. Ballantyne CM, Jones PH, Kelly MT, et al. Long-term efficacy of adding fenofibric acid to moderate-dose statin therapy in patients with persistent elevated triglycerides. Cardiovasc Drugs Ther. 2011;25(1):59-67. 16. 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. 1989;11(1):69-83. 17. 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://care.diabetesjournals.org/content/42/Supplement_1/S103.article-info. 18. Ganda OP, Bhatt DL, Mason RP, Miller M, Boden WE. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343. 19. Hilleman D, Smer A. Prescription omega-3 fatty acid products and dietary supplements are not interchangeable. Manag Care. 2016;25(1):46-52. 20. Dietary supplements: what you need to know. US Food and Drug Administration website. www.fda.gov/food/dietarysupplements/usingdietarysupplements/ucm109760.htm. Updated November 2017. Accessed October 10, 2019. 21. 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.

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

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