Leading medical societies recognize icosapent ethyl (IPE) as an important CV treatment option1-4

ADA Standards of Medical Care in Diabetes for 2019: Now includes a level "A" recommendation to consider icosapent ethyl, marketed as VASCEPA, 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).

  • "It should be noted that data are lacking for other omega-3 fatty acids and results of the REDUCE-IT® trial should not be extrapolated to other products"

European Society of Cardiology/European Atherosclerosis Society: 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.


NLA: 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.


AHA: Released an advisory statement referencing the REDUCE-IT* results and the CV risk-lowering effects of icosapent ethyl.

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

 

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.

ADA=American Diabetes Association; AHA=American Heart Association; NLA=National Lipid Association.

*CV outcomes trial that evaluated the effects of icosapent ethyl in statin-treated adults with well-controlled LDL-C and CV risk factors including TG ≥135 mg/dL, either established CVD or diabetes and other risk factors.

References: 1. 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. 2. 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) [Epub ahead of print August 31, 2019]. Eur Heart J. https://doi.org/10.1093/eurheartj/ehz455. 3. National Lipid Association. NLA position on the use of icosapent ethyl in high and very-high-risk patients. https://www.lipid.org/nla/nla-position-use-icosapent-ethyl-high-and-very-high-risk-patients. Accessed October 11, 2019. 4. Skulas-Ray AC, Wilson PWF, Harris WS, et al. Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association [Epub ahead of print August 19, 2019]. Circulation. doi:10.1161/CIR.0000000000000709.

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