Icosapent ethyl (IPE) recognized worldwide as an important CV treatment option1-5

American Heart Association (AHA) Science Advisory:

Released an advisory statement identifying icosapent ethyl as the first non–LDL-focused lipid therapy to demonstrate CV benefit. IPE was further recommended to be considered first-line therapy for patients with T2DM and CAD whose triglycerides remain elevated (>135 mg/dL) despite maximally tolerated statin and lifestyle changes.1


American Diabetes Association (ADA) Standards of Medical Care in Diabetes for 2019:

ADA gives icosapent ethyl level “A” recommendation for patients with diabetes and ASCVD or other CV risk factors on a statin with controlled LDL-C and elevated TG (135-499 mg/dL).2

  • "It should be noted that data are lacking with other omega‑3 fatty acids and results of the REDUCE-IT® trial should not be extrapolated to other products"
  • Combination therapy (statin/fibrate) has not been shown to improve atherosclerotic cardiovascular disease outcomes and is generally not recommended

American Association of Clinical Endocrinologists (AACE) Consensus Statement:

Recommends to add icosapent ethyl 4 g/day if high ASCVD risk on maximally tolerated statins and TG 135-499 mg/dL.3


National Lipid Association (NLA) Scientific Statement:

Class I, Level B-R (STRONG) recommendation for the CV risk-lowering effects of icosapent ethyl for high-risk and very-high-risk patients with TG 135-499 mg/dL on statin therapy.4


European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) Guidelines:

Recommend that icosapent ethyl, 2g twice a day, should be considered for patients with CV disease who have TG levels 135 mg/dL to 499 mg/dL despite statin treatment, which places them at high risk of CV events, such as heart attack, stroke, or death.5


Leading medical societies emphasize that clinical results with IPE should not be generalized
to any other product

VASCEPA may be affordable for most patients

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10% of patients in the REDUCE-IT trial had TG levels less than 150 mg/dL.

Fenofibrates 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.

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

Please refer to all society statements for further information and recommendations.

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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.

CAD=coronary artery disease.

References: 1. Arnold SV, Bhatt DL, Barsness GW, et al. Clinical Management of Stable Coronary Artery Disease in Patients With Type 2 Diabetes Mellitus: A Scientific Statement From the American Heart Association [epub ahead of print April 13, 2020]. Circulation. doi: 10.1161/CIR.0000000000000766. 2. 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. 3. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the Comprehensive Type 2 Diabetes Management Algorithm – 2020 Executive Summary. Endocr Pract. 2020:26(1):107-139. 4. Orringer CE, Jacobson TA, Maki KC. National Lipid Association Scientific Statement on the use of icosapent ethyl in statin-treated patients with elevated triglycerides and high or very-high ASCVD risk. J Clin Lipidol. 2019;13(6):860-872. 5. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk: The Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS). Eur Heart J. 2020;41(1):111-188.