Amarin Highlights New REDUCE-IT® and Mechanistic Data Presented at European Society of Cardiology (ESC) Congress 2026
Rhea-AI Summary
Amarin (NASDAQ: AMRN) reported multiple new REDUCE-IT and mechanistic findings presented at ESC Congress 2026 in Munich, focused on treatment adherence, long-term outcomes, lipoprotein(a) [Lp(a)], coagulation biomarkers and pathways related to eicosapentaenoic acid (EPA) and icosapent ethyl (IPE).
Post hoc REDUCE-IT analyses described substantial variability in Lp(a) over 24 months, sex differences in study discontinuation, and reductions in tissue factor levels plus lower first cardiovascular event risk with icosapent ethyl in high-risk patients with elevated baseline tissue factor. Mechanistic work showed EPA limited Lp(a) oxidation and favorably modulated endothelial cell protein expression. Amarin also highlighted that new 2026 ESC/European Renal Association guidelines for cardiovascular disease and chronic kidney disease cite REDUCE-IT RENAL, reinforcing support for icosapent ethyl in statin-treated patients with elevated triglycerides and chronic kidney disease.
Positive
- New ESC/ERA 2026 guideline recognition includes REDUCE-IT RENAL and supports icosapent ethyl use in statin-treated patients with elevated triglycerides and chronic kidney disease.
- Post hoc REDUCE-IT coagulation analysis shows icosapent ethyl reduced circulating tissue factor over two years versus placebo in high-risk cardiovascular patients.
- High baseline tissue factor subgroup receiving icosapent ethyl had a significantly lower risk of first cardiovascular events compared with placebo.
- Mechanistic EPA study found EPA reduced primary and secondary oxidation products in Lp(a) and LDL versus comparator antioxidants.
- Endothelial cell experiments showed EPA reversed many protein expression changes caused by oxidized Lp(a) and reduced tissue factor via ERK pathway modulation.
Negative
- None.
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Presentations Expand Understanding of Treatment Adherence, Long-Term Outcomes, Lipoprotein(a), Coagulation Biomarkers, and Potential Mechanisms of Eicosapentaenoic Acid (EPA)
2026 ESC/European Renal Association (ERA) Cardiovascular and Chronic Kidney Disease Guideline Further Reinforces the Clinical Evidence Supporting Icosapent Ethyl
DUBLIN and BRIDGEWATER, N.J., Aug. 31, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular disease (CVD) worldwide, today highlighted findings from multiple Amarin supported presentations at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. The research presented by leading academic collaborators further expanded understanding of treatment adherence, long-term cardiovascular outcomes, lipoprotein(a) [Lp(a)] biology, coagulation biomarkers and potential mechanistic pathways associated with eicosapentaenoic acid (EPA) and icosapent ethyl (IPE). The presentations build upon the significant body of evidence generated from REDUCE-IT and related scientific investigations.
"The research presented at ESC Congress 2026 demonstrates the continued scientific value of REDUCE-IT and the breadth of insights that can be gained through ongoing clinical and mechanistic investigation," said Deepak L. Bhatt, M.D., M.P.H., M.B.A., Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Medicine at the Icahn School of Medicine at Mount Sinai. "These studies advance our understanding of important factors that influence residual cardiovascular risk, including lipoprotein(a) biology, treatment adherence, sex-related differences in study participation, and coagulation pathways. At the same time, mechanistic research continues to provide new insights into how EPA may favorably influence biological processes associated with cardiovascular disease. Despite meaningful progress in cardiovascular prevention, substantial residual risk remains for many patients, underscoring the importance of utilizing proven, complementary therapies as part of a comprehensive treatment strategy. Collectively, these findings further strengthen the body of scientific evidence supporting the role of icosapent ethyl in helping reduce cardiovascular risk in appropriately selected patients."
In addition, the recently published 2026 dedicated ESC Guidelines for the Management of Cardiovascular Disease and Chronic Kidney Disease, developed with the ERA, recognize evidence from the REDUCE-IT RENAL publication showing that icosapent ethyl reduced major adverse cardiovascular events in statin-treated patients with established ASCVD, elevated triglycerides, and chronic kidney disease.i Relative risk reductions were consistent across subgroups divided by estimated glomerular filtration rate (eGFR) at baseline, with absolute benefits largest in patients with eGFR <60 mL/min/1.73m2 by virtue of their higher baseline risk of CVD. This guideline from the ESC and ERA adds to the 70+ leading medical societies globally that recognize the importance of icosapent ethyl for CV risk reduction based on the strength of evidence from REDUCE-IT.
Key Presentation Highlights:
Lipoprotein(a) Variability in High CV Risk Patients with Hypertriglyceridemia and Controlled LDL-C on Statin Therapy – REDUCE-IT Lp(a) Variability
This post hoc analysis of REDUCE-IT explored the variability of lipoprotein(a) [Lp(a)] measurements over 24 months in statin-treated patients with elevated triglycerides and controlled LDL-C. Lp(a) is a marker of residual cardiovascular risk, with elevated levels associated with increased cardiovascular risk even among patients with well-controlled LDL-C, making it an important area of ongoing investigation. Among 8,179 REDUCE-IT participants, 5,036 had serial Lp(a) assessments available for analysis. Investigators observed substantial variability in Lp(a) levels over time, particularly among participants with higher baseline concentrations. Participants with average Lp(a) levels ≥70 mg/dL demonstrated a mean within patient range of 25.3 mg/dL across measurements, while more than one-third of participants with baseline Lp(a) levels between 50 mg/dL and <70 mg/dL had at least one subsequent measurement ≥70 mg/dL. The findings suggest that repeat Lp(a) testing may be valuable for certain patients, particularly as Lp(a)-targeting therapies continue to advance in clinical development.
Eicosapentaenoic Acid (EPA) Limits Rapid Oxidation of Lipoprotein(a) [Lp(a)], Yielding Favorable Changes in Endothelial Cell Protein Expression that May Contribute to Clinical Benefits
This mechanistic investigation evaluated the effects of EPA on Lp(a) oxidation and downstream endothelial cell responses. Researchers found that Lp(a) underwent more rapid oxidation than LDL and demonstrated higher levels of oxidative products. EPA significantly reduced both primary and secondary oxidation products in Lp(a) and LDL, effects that were not consistently observed with comparator antioxidants. The study further demonstrated that oxidized Lp(a) altered the expression of multiple proteins involved in cellular stress responses and vascular injury, with many of these changes substantially reversed by EPA treatment. These findings provide additional mechanistic evidence that EPA may favorably influence pathways linked to endothelial dysfunction and cardiovascular risk associated with oxidized lipoproteins, including Lp(a) that is specifically associated with higher residual risk.
Sex Differences in Early Study Discontinuation and Study Drug Withdrawal: Insights from REDUCE-IT
This post hoc analysis examined sex-related differences in treatment persistence among REDUCE-IT participants. In line with previous coronary artery disease studies, women in REDUCE-IT discontinued study participation and study medication earlier and more frequently than men, resulting in reduced follow-up duration and less time on therapy. Importantly, no significant differences were observed between treatment groups, suggesting these findings were not specific to icosapent ethyl treatment and were also seen in the placebo arm. Withdrawal of consent was the most common cause of study discontinuation, while patient preference was the most frequently reported reason for study drug withdrawal. The analysis highlights the importance of understanding barriers to long-term participation and treatment adherence in cardiovascular clinical trials and clinical practice, particularly among women.
Effects of Icosapent Ethyl on Coagulation Biomarkers and Their Association with Event-Free Survival in High-Risk Cardiovascular Patients: A Post Hoc Analysis of REDUCE-IT
This analysis evaluated the relationship between icosapent ethyl treatment, tissue factor (TF) - a key initiator of the coagulation cascade, and cardiovascular outcomes. Among REDUCE-IT participants, circulating TF levels were reduced after two years of treatment with icosapent ethyl compared with placebo. In patients with elevated baseline TF levels, treatment with icosapent ethyl was associated with a significantly lower risk of first cardiovascular events compared with placebo. Complementary laboratory studies demonstrated that EPA reduced tissue factor expression in endothelial cells through modulation of the extracellular signal-regulated kinase (ERK) signaling pathway. Collectively, these findings suggest that effects on coagulation and thrombosis-related pathways may contribute to the cardiovascular benefits observed with icosapent ethyl.
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.ii The primary results of REDUCE-IT were published in The New England Journal of Medicine in November 2018.iii The total events results of REDUCE-IT were published in the Journal of the American College of Cardiology in March 2019.iv Dr. Bhatt receives research funding from Amarin paid to Mount Sinai Hospital for his role as the study Chair.
About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) 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 thirty 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 the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Slovenia, Romania, 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% vs2% ) 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% vs10% ) 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% vs3% ), peripheral edema (7% vs5% ), constipation (5% vs4% ), gout (4% vs3% ), and atrial fibrillation (5% vs4% ). - Common adverse reactions in the hypertriglyceridemia trials (incidence >
1% more frequent than placebo): arthralgia (2% vs1% ) and oropharyngeal pain (1% vs0.3% ). - 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 WWW.VASCEPA.COM.
Europe
For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf
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 outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; 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 and subsequent quarterly reports on Form 10-Q. 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 Contact Information
Media Inquiries:
Amarin Corporation plc
PR@amarincorp.com
Investor Inquiries:
Devin Sullivan & Conor Rodriguez
The Equity Group on Behalf of Amarin
devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com
Investor.relations@amarincorp.com
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i 2026 ESC Guidelines for the management of cardiovascular disease and chronic kidney disease. Eur Heart J. 2026. doi:10.1093/eurheartj/ehag098.
ii 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.
iii 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. DOI: 10.1056/NEJMoa1812792
iv 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.
