Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT® Post Hoc Analysis Published in the European Journal of Preventive Cardiology

Peer-reviewed paper indicates icosapent ethyl (IPE) was associated with fewer total hospitalizations and fewer days lost due to hospitalization and death, providing additional insights on the effects of IPE on patient-centered measures of total disease burden

DUBLIN and BRIDGEWATER, N.J., March 02, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, today highlighted recently published data in the  showing in a post hoc analysis of the landmark REDUCE-IT study that, among statin-treated participants with elevated triglycerides and known CVD or with diabetes and other risk factors, patients treated with VASCEPA^®/VAZKEPA^® (icosapent ethyl) (IPE) experienced fewer total hospitalizations and fewer days lost due to hospitalization and death, providing additional insights on the effects of IPE on patient-centered measures of total disease burden.ⁱ

The analysis evaluated 8,179 participants randomized to receive either IPE 2 g twice daily or placebo and followed for a median of five years and determined if treatment with IPE would decrease the frequency and duration of hospitalizations.

Commenting on the published findings, Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital at the Icahn School of Medicine at Mount Sinai in New York, said, ”What stands out most in this analysis is the real-world relevance for patients and their families. Fewer hospitalizations can make a meaningful difference in daily life - allowing people to maintain independence and spend more time at home. These findings extend the benefits of treatment with IPE beyond cardiovascular prevention to potentially reduce the burden of hospitalizations and increase the chances of an individual living without hospitalization."

Lead author Michael Szarek, PhD, Mount Sinai Fuster Heart Hospital at the Icahn School of Medicine at Mount Sinai in New York and University of Colorado Anschutz Medical Campus, Aurora, CO, added: “For patients already managing heart disease or diabetes, every day outside the hospital matters. In this high-risk population, we saw reductions not only in how often individuals were hospitalized, but also in how much time they lost to being in the hospital or from premature death. These patient focused outcomes reinforce that IPE may help people spend more time living their lives and less time receiving acute medical care - a result with great significance for patients, their families, and the healthcare system at large.”

Data from REDUCE-IT have consistently shown robust relative and absolute risk reductions in the primary analyses and several sub-group analyses, which led to incorporation of IPE in multiple guidelines and consensus statements globally.ⁱⁱ

About the Analysis

In this post hoc analysis of REDUCE-IT, investigators quantified the effects of IPE on total hospitalizations and days lost to hospitalization and death.

Among 8,179 statin-treated REDUCE-IT patients with established cardiovascular disease or age ≥50 years with diabetes and ≥1 additional risk factor, fasting triglyceride 1.69-5.63 mmol/L (135-499 mg/dL), and low-density lipoprotein cholesterol 1.06-2.59 mmol/L (41-100 mg/dL), total hospitalizations were analyzed with a competing risks marginal model for total events. The likelihood of no days lost to hospitalization and death and the rate of days lost among those who were hospitalized or died during the study were analyzed with a zero-inflated Poisson regression model. During a median 5.0 years of follow-up, IPE treatment was associated with fewer total hospitalizations (HR (95% CI) = 0.91 (0.84, 0.98), P = 0.017). Participants randomized to IPE were more likely to survive until the end of the study without hospitalization (OR (95% CI) = 1.12 (1.02, 1.22), P = 0.016) and had fewer days lost among those who were hospitalized or died (RR (95% CI) = 0.93 (0.93, 0.94), P < 0.001).

In conclusion, IPE was associated with fewer total hospitalizations and fewer days lost due to hospitalization and death, providing additional insights on the effects of IPE on patient-centered measures of total disease burden.

The analysis highlighted above was funded by Amarin. Dr. Deepak L. Bhatt served as the principal investigator for REDUCE-IT and his institution received research funding from Amarin.

About Amarin

Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD.

About REDUCE-IT^®

REDUCE-IT was a global cardiovascular outcomes study designed to evaluate the effect of VASCEPA in adult patients with LDL-C controlled to between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy and various cardiovascular risk factors including persistent elevated triglycerides between 135-499 mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other cardiovascular risk factor (primary prevention cohort).

REDUCE-IT, conducted over seven years and completed in 2018, followed 8,179 patients at over 400 clinical sites in 11 countries with the largest number of sites located within the United States. REDUCE-IT was conducted based on a special protocol assessment agreement with FDA. The design of the REDUCE-IT study was published in March 2017 in Clinical Cardiology.ⁱⁱⁱ The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.^iv The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.^v These and other publications can be found in the R&D section on the company’s website at .

About Cardiovascular Risk 

Cardiovascular disease is the number one cause of death in the world. In the United States alone, cardiovascular disease results in 859,000 deaths per year.^vi And the number of deaths in the United States attributed to cardiovascular disease continues to rise. In addition, in the United States there are 605,000 new and 200,000 recurrent heart attacks per year (approximately 1 every 40 seconds). Stroke rates are 795,000 per year (approximately 1 every 40 seconds), accounting for 1 of every 19 U.S. deaths. In aggregate, in the United States alone, there are more than 2.4 million major adverse cardiovascular events per year from cardiovascular disease or, on average, 1 every 13 seconds. 

Controlling bad cholesterol, also known as LDL-C, is one way to reduce a patient’s risk for cardiovascular events, such as heart attack, stroke or death. However, even with the achievement of target LDL-C levels, millions of patients still have significant and persistent risk of cardiovascular events, especially those patients with elevated triglycerides. Statin therapy has been shown to control LDL-C, thereby reducing the risk of cardiovascular events by 25-35%.^vii Significant cardiovascular risk remains after statin therapy. People with elevated triglycerides have 35% more cardiovascular events compared to people with normal (in range) triglycerides taking statins.^viii,ix,x

About VASCEPA^®/VAZKEPA^® (icosapent ethyl) Capsules 

VASCEPA capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria.

United States Indications and Limitation of Use 

VASCEPA 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 two or more additional risk factors for cardiovascular disease.
• 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 should be monitored for bleeding.
  
  
  
  

FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT  

Europe

For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA^® in Europe, please visit: 

Globally, prescribing information varies; refer to the individual country product label for complete information. 

Forward-Looking Statements 

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s key achievements in 2024 and the potential impact and outlook for achievements in 2025 and beyond; Amarin’s 2025 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; expectations regarding potential strategic collaboration and licensing agreements with third parties, including our ability to attract additional collaborators, as well as our plans and strategies for entering into potential strategic collaboration and licensing agreements and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin.

All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate. Investors and others should note that Amarin communicates with its investors and the public using the company website (), the investor relations website (), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. 

Amarin Contact Information 

Media Inquiries: 

Tegan Berry 

Amarin Corporation plc 

Investor Inquiries: 

Devin Sullivan & Conor Rodriguez 

The Equity Group on Behalf of Amarin

or

_____________________________________________

ⁱ Michael Szarek, Deepak L Bhatt, Michael Miller, Eliot A Brinton, Jean-Claude Tardif, Christie M Ballantyne, Steven B Ketchum, Mandeep R Mehra, Ph Gabriel Steg, on behalf of the REDUCE-IT Investigators, Effects of icosapent ethyl on risk and duration of hospitalizations and death in REDUCE-IT, European Journal of Preventive Cardiology, 2026;, zwag040,

ⁱⁱMiller M, Tokgozoglu L, Parhofer KG, Handelsman Y, Leiter LA, Landmesser U, Brinton EA, Catapano AL. Icosapent ethyl for reduction of persistent cardiovascular risk: a critical review of major medical society guidelines and statements. Exp Rev Cardiovasc Ther. 2022;20:609-625.

 

ⁱⁱⁱ Bhatt DL, Steg PG, Brinton E, et al., on behalf of the REDUCE-IT Investigators. Rationale and Design of REDUCE‐IT: Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.

^iv Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22.

^v 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;73:2791-2802.

^vi American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.

^vii Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.

^viii Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.

^ix Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.

^x Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563