New REDUCE-IT® Legacy Analysis Presented at European Society of Cardiology (ESC) Congress 2026 Suggests Persistent Cardiovascular Benefit Following Icosapent Ethyl Treatment Cessation in Adherent Patients
Rhea-AI Summary
Amarin (NASDAQ:AMRN) reported new post hoc “REDUCE-IT Legacy” data presented at ESC Congress 2026, based on the REDUCE-IT® cardiovascular outcomes trial of 8,179 statin-treated, high‑risk patients with elevated triglycerides. Among 6,921 “high adherers” who stayed on icosapent ethyl (IPE) for at least 1.5 years, investigators observed approximately 29–30% relative risk reduction in the primary composite endpoint versus placebo, compared with 25% in the intention‑to‑treat population.
In a secondary prevention cohort of 1,318 patients who discontinued study drug after a mean 2.3 years, Kaplan‑Meier curves remained separated with a hazard ratio of 0.73 during total follow‑up and 0.73 after discontinuation, suggesting a potential “legacy” effect with no apparent loss of benefit over one to four years off therapy.
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Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 24 | ESC presentation preview | Positive | -1.8% | Upcoming REDUCE-IT adherence, legacy-effect, and mechanistic analyses at ESC Congress |
| Jul 29 | Second-quarter earnings | Positive | +1.5% | Lower expenses, improved loss, higher cash, and continued international demand growth |
| Jul 15 | Earnings date announcement | Neutral | +0.6% | Scheduled release of second-quarter financial results and conference call |
| Jun 30 | Product positioning update | Positive | +3.3% | Reaffirmed VASCEPA's guideline-recommended role amid injectable competition |
| May 27 | REDUCE-IT clinical analysis | Positive | +1.5% | Risk-weighted apoB improved identification of residual cardiovascular risk |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent reactions varied: three constructive announcements aligned with positive returns, while the August 24 ESC presentation diverged with a -1.77% reaction.
Key Terms
post hoc analysis technical
intention-to-treat analysis medical
hazard ratio medical
kaplan-meier event curves medical
double-blind medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Data Supports Approximately
DUBLIN and BRIDGEWATER, N.J., Aug. 28, 2026 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular disease worldwide, today highlighted a new post hoc analysis from the landmark REDUCE-IT® cardiovascular outcomes trial, presented at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. The analysis showed that highly adherent participants who remained on icosapent ethyl (IPE) treatment for at least 1.5 years experienced approximately
"REDUCE-IT remains a landmark cardiovascular outcomes trial in preventive cardiology, and more than seven years after its completion we continue to generate meaningful insights from this important dataset," said Steven Ketchum, Ph.D., EVP, President R&D, & Chief Scientific Officer at Amarin. "The findings from this analysis suggest that patients who remained adherent on treatment long enough to achieve the full benefit of therapy may continue to experience cardiovascular protection for additional years after discontinuation. While exploratory in nature, these data provide important insights into the durability of the treatment effect and add to the body of scientific evidence generated from REDUCE-IT."
Key findings from the post hoc analysis are outlined below:
Adherence and Legacy Effects of High Dose Eicosapentaenoic Acid in Hypertriglyceridemia and High CV Risk – REDUCE-IT Legacy
A new analysis from the landmark REDUCE-IT trial evaluated the impact of treatment adherence on cardiovascular (CV) outcomes and explored whether the benefits of icosapent ethyl (IPE), a purified form of eicosapentaenoic acid, may persist after treatment discontinuation among patients who chose to discontinue the study medication while still in the double-blind trial follow up to gain further insight into the nature of the risk reduction on this agent. Investigators assessed outcomes among statin-treated patients with elevated triglycerides and high CV risk to better understand the relationship between sustained treatment exposure and long-term clinical benefit.
Among the 8,179 participants enrolled in REDUCE-IT, the intention-to-treat analysis demonstrated a
Beyond the adherence findings, investigators explored whether CV benefits achieved during treatment persisted after study drug discontinuation. In the secondary prevention cohort, 1,318 participants who had taken study drug for at least three months and subsequently discontinued treatment (mean of 2.3 years on therapy) maintained separation of Kaplan-Meier event curves throughout their entire study follow-up, with a hazard ratio of 0.73. Notably, a similar hazard ratio of 0.73 was observed for CV events occurring after study drug discontinuation, suggesting that benefits achieved during treatment may persist for years after therapy is stopped, with no apparent diminution in benefit over the subsequent one to four years of follow-up (participants were off study drug for a mean of 2.1 years).
“The observed pattern is consistent with a potential legacy effect and reinforces the importance of long-term adherence to treatment in high-risk CV patients,” said Chris Packard, Ph.D., D.Sc., Professor of Vascular Biochemistry, University of Glasgow. “The legacy effect, in which the benefits of an intervention persist for years after the trial ends, is an established concept in cardiovascular medicine. It was described in the long-term follow-up in the 20-year follow-up of the West of Scotland Coronary Prevention Study (WOSCOPS), in which approximately five years of treatment by statins was associated with cardiovascular benefits that persisted across two decades of follow-up.i Our findings suggest that sustained treatment with IPE may influence the trajectory of CV disease, resulting in durable clinical benefits beyond the period of active treatment.”
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
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 Ford I, Murray H, McCowan C, Packard CJ. Long-Term Safety and Efficacy of Lowering Low-Density Lipoprotein Cholesterol With Statin Therapy: 20-Year Follow-Up of West of Scotland Coronary Prevention Study. Circulation. 2016;133(11):1073-80. doi: 10.1161/CIRCULATIONAHA.115.019014.
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.
