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In a prespecified and exploratory analysis of adults on maximally tolerated statins with TG ≥150 mg/dL and established CVD or diabetes and ≥2 CVD risk factors

When added to a statin, significantly reduce the risk of the next CV event with VASCEPA1,2

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30% RRR IN TOTAL EVENTS

RR=0.70 (95% CI, 0.62-0.78); P=0.00000000036

Reduction in first, subsequent, and total CV events with VASCEPA

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Reduction in first, subsequent, and total CV events with VASCEPA

Adapted from the Journal of the American College of Cardiology, Vol 73/22, Bhatt DL, Steg PG, Miller M, et al. Effects of icosapent ethyl on total ischemic events, pp 2791-2802. Copyright 2019, with permission from Elsevier.

CI=confidence interval; RR=rate ratio; RRR=relative risk reduction.

  • VASCEPA demonstrated a 30% risk reduction in total CV events
  • Primary composite endpoint was defined as a composite of Nonfatal MI, Nonfatal Stroke, CV Death, Coronary Revascularization, or Unstable Angina Requiring Hospitalization

See the data in the JACC publication

Even after the first event, there is still substantial reduction in subsequent events with VASCEPA

In the REDUCE-IT® study, over 5 years VASCEPA reduced 159 events (comprising Nonfatal MI, Nonfatal Stroke, CV Death, Coronary Revascularization, or Unstable Angina Requiring Hospitalization) for every 1000 patients.

Recurrent event exploratory analysis reflects a series of prespecified statistical models, one of which was post hoc. Data not opined on by FDA.

Please see the full publication in the Journal of the American College of Cardiology, as noted above.

IPE is recognized by multiple organizations3-8

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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 contacting AmarinConnect at 1-855-VASCEPA, emailing [email protected], or calling 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.

Visual representations are for illustrative purposes only. The capsule shown is not an identical representation of the product.

CV=cardiovascular; CVD=cardiovascular disease; FDA=Food and Drug Administration; JACC=Journal of the American College of Cardiology; MI=myocardial infarction; TG=triglyceride.

*In the REDUCE-IT study, over 5 years VASCEPA reduced 159 events (comprising Nonfatal MI, Nonfatal Stroke, CV Death, Coronary Revascularization, or Unstable Angina Requiring Hospitalization) for every 1000 patients versus placebo.

References: 1. Bhatt DL, Steg PG, Miller M, et al; on behalf of the REDUCE-IT Investigators. Effects of icosapent ethyl on total ischemic events: from REDUCE-IT. J Am Coll Cardiol. 2019;73(22):2791-2802. 2. Bhatt DL, Steg PG, Miller M, et al. Reduction in total ischemic events in the reduction of cardiovascular events with icosapent ethyl–intervention trial. Presented at: American College of Cardiology 68th Annual Scientific Session & Expo; March 16-18, 2019; New Orleans, LA. 3. 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. 4. American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes—2021. Diabetes Care. 2021;44(suppl 1):S125-S150. 5. 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. Circulation. 2020;141(19):e779-e806. 6. 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. 7. 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. 8. Virani SS, Morris PB, Agarwala A, et al. 2021 ACC expert consensus decision pathway on the management of ASCVD risk reduction in patients with persistent hypertriglyceridemia: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2021;78(9):960-993.

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