Proven CV risk reduction on top of standard of care1*

For adults on maximally tolerated statins with TG ≥150 mg/dL and established CVD or diabetes and ≥2 CVD risk factors

Additional 25% risk reduction in CV events1,2

See Graph

25% RRR; NNT=21

ARR=4.8%; P=0.00000001

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

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

ARR=absolute risk reduction; MACE=major adverse cardiovascular events; NNT=number needed to treat; RRR=relative risk reduction.

At Year 5 since randomization, 1430 patients remained in the VASCEPA arm vs 1358 patients in the placebo arm.

  • The CV event curve for VASCEPA visually separated from the placebo event curve at approximately 1 year and remained separated throughout the follow-up period
  • 5-point MACE primary composite endpoint was defined as Nonfatal MI, Nonfatal Stroke, CV Death, Coronary Revascularization, or Unstable Angina Requiring Hospitalization
  • Patients in the Placebo + Statin arm had a 28.3% event rate, which is consistent for this high-risk population

A randomized, double-blind, placebo-controlled trial for adults with eCVD or with diabetes and other risk factors, receiving statin therapy, and with modestly elevated TG (median baseline 216 mg/dL) and well-controlled LDL-C (median baseline 75 mg/dL). 8179 patients (VASCEPA 4 g/d [n=4089]; placebo [n=4090]) were followed for a median of 4.9 years.

Patients in the VASCEPA CV Outcomes Trial (REDUCE-IT) received standard-of-care medications including statins (100%), antihypertensives (95%), antiplatelet medication (79%), ACE inhibitors (52%), ARBs (27%), and beta blockers (71%).

See the data in the NEJM publication


Unprecedented reductions across secondary endpoints1,2

NNT=number needed to treat; RRR=relative risk reduction.

  • 3-point MACE key secondary composite endpoint was defined as Nonfatal MI, Nonfatal Stroke, or CV Death
  • 35% reduction in Coronary Revascularization; P<0.001
  • 32% reduction in Unstable Angina Requiring Hospitalization; P=0.002

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Robust CV risk reduction independent of baseline or achieved TG levels1,2

Primary endpoint by achieved triglyceride level at 1 year

Reprinted from The New England Journal of Medicine, Vol 380, Bhatt DL, Steg PG, Miller M, et al. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia, pp 11-22. Copyright 2019, with permission from Massachusetts Medical Society

At Year 5 since randomization, 571 patients with TG <150 mg/dL and 803 patients with TG ≥150 mg/dL remained in the VASCEPA arm vs 1358 patients in the placebo arm.

  • Median percent change in TG for VASCEPA 4 g/d compared to placebo was -19.7%. Median percent change in LDL-C for VASCEPA 4 g/d compared to placebo was -6.6%
  • VASCEPA has multiple effects that extend beyond TG lowering, including increased EPA lipid composition from carotid plaque specimens. Direct clinical meaning of the findings is not clear

Reduction in CV events was consistent in patients regardless of TG levels1,2

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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.

*Patients in the VASCEPA CV Outcomes Trial (REDUCE-IT) received standard-of-care medications including statins (100%), antihypertensives (95%), antiplatelet medication (79%), ACE inhibitors (52%), ARBs (27%), and beta blockers (71%).

At Year 5 since randomization, 1562 patients remained in the VASCEPA arm vs 1487 patients in the placebo arm.

First occurrence of event.

References: 1.Bhatt DL, Steg PG, Miller M, et al; for the REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22. Bhatt DL. AHA 2018, Chicago. 2. VASCEPA [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.