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Prior MI Subgroup Data

In a prespecified and post-hoc analysis of adults on maximally tolerated statins with TG ≥150 mg/dL and prior MI1,2

Cardiovascular risk reduction seen in patients with prior MI in REDUCE-IT® subgroup analysis2

VASCEPA significantly reduced the risk of the next CV event* in patients with prior MI by 26%2

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26% RRR

ARR=5.9%; P=0.00001

Composite first occurrence of 5-point MACE (primary endpoint)

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Composite first occurrence of 5-point MACE (primary endpoint)

Adapted from the Journal of the American College of Cardiology, Vol 79/17, Gaba P, Bhatt DL, Steg PG, et al. Prevention of ischemic events and mortality with icosapent ethyl in patients with prior myocardial infarction, pp 1660-1671. Copyright 2022, with permission from Elsevier.

At Year 5 since randomization, 1430 patients remained in the VASCEPA arm vs 1358 patients in the placebo arm in the overall trial population; 698 patients remained in the VASCEPA arm vs 677 patients in the placebo arm in the prespecified prior MI subpopulation.

  • VASCEPA reduced the incidence of the primary composite endpoint of Nonfatal MI, Nonfatal Stroke, CV Death, Coronary Revascularization, or Unstable Angina Requiring Hospitalization from 26.1% to 20.2% vs placebo (HR=0.74 [95% CI, 0.65-0.85]; P=0.00001)

REDUCE-IT was not specifically powered to examine individual cardiovascular endpoints or patient subgroups, therefore P-values are nominal and exploratory with no adjustment for multiple comparisons. In addition, enrollment was not stratified by prior MI or time since MI, and patients were not enrolled at the time of their MI. However, significant reductions were demonstrated for prior MI patients treated with icosapent ethyl, in the primary endpoint, the key secondary endpoint, and other secondary and tertiary endpoints. Together, these REDUCE-IT sub-analyses support the robustness and consistency of the clinical benefit of icosapent ethyl therapy in patients with prior MI.

VASCEPA significantly reduced the risk of MI, stroke, or CV death in patients with prior MI by 29%2

See Graph

29% RRR

ARR=4.7%; P=0.00006

Composite first occurrence of 3-point MACE (key secondary endpoint)

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Composite first occurrence of 3-point MACE (key secondary endpoint)

Adapted from the Journal of the American College of Cardiology, Vol 79/17, Gaba P, Bhatt DL, Steg PG, et al. Prevention of ischemic events and mortality with icosapent ethyl in patients with prior myocardial infarction, pp 1660-1671. Copyright 2022, with permission from Elsevier.

At Year 5 since randomization, 1562 patients remained in the VASCEPA arm vs 1487 in the placebo arm in the overall trial population for the key secondary outcome; 698 patients remained in the VASCEPA arm vs 678 patients in the placebo arm in the prespecified prior MI subpopulation.

  • VASCEPA reduced the incidence of the key secondary composite endpoint of Nonfatal MI, Nonfatal Stroke, or CV Death from 18.0% to 13.3% vs placebo (HR=0.71 [95% CI, 0.61-0.84]; P=0.00006)

VASCEPA, when added to a statin, significantly reduced total CV events among patients with prior MI2

See Graph

35% RRR

P=0.0000001

Reductions in total primary composite endpoint events

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Reductions in total primary composite endpoint events

Adapted from the Journal of the American College of Cardiology, Vol 79/17, Gaba P, Bhatt DL, Steg PG, et al. Prevention of ischemic events and mortality with icosapent ethyl in patients with prior myocardial infarction, pp 1660-1671. Copyright 2022, with permission from Elsevier.

At Year 5 since randomization, 1430 patients remained in the VASCEPA arm vs 1358 patients in the placebo arm in the overall trial population; 698 patients remained in the VASCEPA arm vs 677 patients in the placebo arm in the prespecified prior MI subpopulation.

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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.

ARR=absolute risk reduction; CI=confidence interval; CV=cardiovascular; CVD=cardiovascular disease; HR=hazard ratio; MACE=major adverse cardiovascular events; MI=myocardial infarction; NNT=number needed to treat; RRR=relative risk reduction; TG=triglyceride.

*Cardiovascular events including myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization.

References: 1. VASCEPA [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2021. 2. Gaba P, Bhatt DL, Steg PG, et al; on behalf of the REDUCE-IT Investigators. Prevention of cardiovascular events and mortality with icosapent ethyl in patients with prior myocardial infarction. J Am Coll Cardiol. 2022;79(17):1660-1671.

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