New REDUCE-IT庐 Analyses Presented at ESC 2025 Include Data Showing VASCEPA庐/VAZKEPA庐 (Icosapent Ethyl) Therapy Resulted in 9% Fewer Total Hospitalizations & Reduces Cardiovascular Disease Risk in Certain High-Risk Patient Subgroups
Amarin Corporation (NASDAQ:AMRN) presented three significant sub-analyses from the REDUCE-IT庐 trial at ESC Congress 2025, demonstrating the effectiveness of VASCEPA庐/VAZKEPA庐 (icosapent ethyl) in reducing cardiovascular risks. Key findings showed that the treatment resulted in 9% fewer total hospitalizations and significant cardiovascular risk reductions across multiple patient subgroups.
The analyses revealed a 44% relative risk reduction in cardiovascular events for patients with CKM syndrome and eGFR <60. The treatment showed significant reductions in major adverse cardiovascular events across all quartiles of baseline ApoB and TRL-C concentrations. Additionally, the 2025 ESC/EAS Dyslipidemia Guideline Update reaffirmed icosapent ethyl as a Class IIA recommended therapy for high-risk or very high-risk patients.
Amarin Corporation (NASDAQ:AMRN) ha presentato tre importanti sotto-analisi dello studio REDUCE-IT庐 al Congresso ESC 2025, dimostrando l'efficacia di VASCEPA庐/VAZKEPA庐 (icosapent ethyl) nella riduzione del rischio cardiovascolare. I risultati principali hanno mostrato che il trattamento ha comportato il 9% in meno di ricoveri totali e rilevanti diminuzioni del rischio cardiovascolare in diversi sottogruppi di pazienti.
Le analisi hanno evidenziato una riduzione del rischio relativo del 44% per eventi cardiovascolari nei pazienti con sindrome CKM e eGFR <60. Il trattamento ha ridotto significativamente gli eventi cardiovascolari maggiori in tutti i quartili delle concentrazioni basali di ApoB e TRL-C. Inoltre, l鈥橝ggiornamento 2025 delle Linee Guida ESC/EAS sulla Dislipidemia ha confermato l鈥檌cosapent ethyl come terapia raccomandata di Classe IIA per pazienti ad alto o altissimo rischio.
Amarin Corporation (NASDAQ:AMRN) present贸 tres suban谩lisis relevantes del ensayo REDUCE-IT庐 en el Congreso ESC 2025, demostrando la eficacia de VASCEPA庐/VAZKEPA庐 (icosapent ethyl) para reducir el riesgo cardiovascular. Los hallazgos clave indicaron que el tratamiento result贸 en un 9% menos de hospitalizaciones totales y reducciones significativas del riesgo cardiovascular en m煤ltiples subgrupos de pacientes.
Los an谩lisis mostraron una reducci贸n relativa del riesgo del 44% en eventos cardiovasculares para pacientes con s铆ndrome CKM y eGFR <60. El tratamiento produjo reducciones significativas en los eventos cardiovasculares adversos mayores en todos los cuartiles de las concentraciones basales de ApoB y TRL-C. Adem谩s, la Actualizaci贸n 2025 de la Gu铆a ESC/EAS sobre Dislipidemias reafirm贸 el icosapent ethyl como terapia recomendada de Clase IIA para pacientes de alto o muy alto riesgo.
鞎勲毽� 旖旐嵓霠堨澊靺�(NASDAQ:AMRN)鞚� REDUCE-IT庐 鞛勳儊鞁滍棙鞚� 靹� 臧�歆� 欤检殧 頃橃渼 攵勳劃 瓴瓣臣毳� ESC 頃欗殞 2025鞐愳劀 氚滍憸頃橂┌ VASCEPA庐/VAZKEPA庐(鞚挫綌靷帨韸� 鞐愴嫺)鞚� 鞁槇甏� 鞙勴棙 臧愳唽 須臣毳� 鞛呾頄堨姷雼堧嫟. 欤检殧 瓴瓣臣鞐� 霐半ゴ氅� 頃措嫻 旃橂電� 鞝勳泊 鞛呾洂 瓯挫垬 9% 臧愳唽鞕� 鞐煬 頇橃瀽 頃橃渼甑办棎靹� 鞙犾潣頃� 鞁槇甏� 鞙勴棙 臧愳唽毳� 氤挫榾鞀惦媹雼�.
攵勳劃 瓴瓣臣 CKM 歃濏泟甑� 氚� eGFR <60鞚� 頇橃瀽鞐愳劀 鞁槇甏� 靷贝鞐� 雽�頃� 靸侂寑 鞙勴棙 44% 臧愳唽臧� 甏�彀半悩鞐堨姷雼堧嫟. 霕愴暅 旮办爛 ApoB 氚� TRL-C 雴嶋弰鞚� 氇摖 靷秳鞙勳棎靹� 欤检殧 鞁槇甏� 靷贝鞚� 鞙犾潣頃橁矊 臧愳唽頄堨姷雼堧嫟. 雿旊秷鞏� 2025雲� ESC/EAS 鞚挫儊歆�歆堩槇歃� 歆�旃� 鞐呺嵃鞚错姼電� 瓿犾渼項� 霕愲姅 毵れ毎 瓿犾渼項� 頇橃瀽鞐� 雽�頃� 鞚挫綌靷帨韸� 鞐愴嫺鞚� 韥措灅鞀� IIA 甓岅碃 旃橂搿� 鞛檿鞚疙枅鞀惦媹雼�.
Amarin Corporation (NASDAQ:AMRN) a pr茅sent茅 trois sous-analyses importantes de l'essai REDUCE-IT庐 au congr猫s ESC 2025, montrant l'efficacit茅 de VASCEPA庐/VAZKEPA庐 (icosapent ethyl) pour r茅duire les risques cardiovasculaires. Les r茅sultats cl茅s ont montr茅 que le traitement entra卯nait 9% d'hospitalisations totales en moins et des r茅ductions significatives du risque cardiovasculaire dans plusieurs sous-groupes de patients.
Les analyses ont r茅v茅l茅 une r茅duction relative du risque de 44% pour les 茅v茅nements cardiovasculaires chez les patients pr茅sentant le syndrome CKM et un eGFR <60. Le traitement a significativement r茅duit les 茅v茅nements cardiovasculaires majeurs dans tous les quartiles des concentrations basales d'ApoB et de TRL-C. De plus, la mise 脿 jour 2025 des recommandations ESC/EAS sur la dyslipid茅mie a r茅affirm茅 l'icosapent ethyl comme th茅rapie recommand茅e de Classe IIA pour les patients 脿 risque 茅lev茅 ou tr猫s 茅lev茅.
Amarin Corporation (NASDAQ:AMRN) stellte auf dem ESC-Kongress 2025 drei bedeutende Subanalysen der REDUCE-IT庐-Studie vor, die die Wirksamkeit von VASCEPA庐/VAZKEPA庐 (Icosapent ethyl) bei der Reduktion kardiovaskul盲rer Risiken belegen. Zentrale Ergebnisse zeigten, dass die Behandlung zu 9% weniger Krankenhausaufenthalten insgesamt sowie zu signifikanten Risikominderungen in mehreren Patientensubgruppen f眉hrte.
Die Analysen ergaben eine relative Risikoreduktion von 44% f眉r kardiovaskul盲re Ereignisse bei Patienten mit CKM-Syndrom und eGFR <60. Die Behandlung verringerte bedeutende kardiovaskul盲re Ereignisse in allen Quartilen der baseline ApoB- und TRL-C-Konzentrationen erheblich. Dar眉ber hinaus best盲tigte das ESC/EAS-Leitlinienupdate 2025 zur Dyslipid盲mie Icosapent ethyl als Klasse IIA empfohlene Therapie f眉r Patienten mit hohem oder sehr hohem Risiko.
- 44% relative risk reduction in cardiovascular events for CKM syndrome patients with eGFR <60
- 9% reduction in total hospitalizations (HR 0.91, P=0.017)
- Significant MACE reductions across all ApoB quartiles (HR 0.72-0.80)
- Reaffirmation as Class IIA recommended therapy in ESC/EAS guidelines
- 12% increased likelihood of surviving without hospitalization (OR 1.12, P=0.016)
- None.
Insights
New REDUCE-IT analyses reinforce VASCEPA's cardiovascular benefits across high-risk groups, strengthening its clinical position with regulatory endorsement.
The new REDUCE-IT sub-analyses presented at ESC 2025 provide robust additional evidence supporting icosapent ethyl's efficacy in cardiovascular risk reduction across several important patient populations. The data showing 9% fewer total hospitalizations represents a meaningful patient-centered outcome that translates to real-world clinical benefits and potential healthcare cost savings.
Particularly impressive is the 44% relative risk reduction (HR 0.56) in the primary composite endpoint for patients with CKM syndrome and compromised kidney function (eGFR <60), yielding an absolute risk reduction of 11.2% and a remarkably low NNT of just 9. This indicates exceptional clinical efficiency in this high-risk subgroup.
The consistent cardiovascular benefit across all quartiles of ApoB and most quartiles of TRL-C levels demonstrates that icosapent ethyl's protective effects extend beyond simple triglyceride lowering, suggesting multiple mechanisms of action. This breadth of efficacy supports broader clinical utility than previously understood.
The reaffirmation of icosapent ethyl as a Class IIA recommended therapy in the ESC/EAS guidelines is significant, particularly in the context of the guideline explicitly noting the lack of established ASCVD risk reduction with fibrates and mixed EPA+DHA supplements. This creates clear differentiation between prescription-grade icosapent ethyl and other triglyceride-lowering approaches.
These findings collectively strengthen the clinical case for VASCEPA/VAZKEPA in contemporary cardiovascular risk management, potentially expanding its utilization in patients with metabolic syndrome, kidney dysfunction, and various lipid profiles beyond the initial approval population.
-- 2025 ESC/EAS Dyslipidemia Guideline Focused Update Reaffirms High Dose Icosapent Ethyl as Class IIA Recommended Therapy in High-Risk or Very High-Risk Patients Based on REDUCE-IT --
DUBLIN and BRIDGEWATER, N.J., Aug. 30, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today highlighted three sub-analyses from the REDUCE-IT庐 trial describing the impact of VASCEPA庐/VAZKEPA庐听(icosapent ethyl - IPE) administration on cardiovascular disease (CVD) risk associated with Cardiovascular-Kidney-Metabolic (CKM) syndrome, major adverse cardiovascular events (MACE) stratified by baseline apolipoprotein B (ApoB) and fasting triglyceride rich lipoprotein cholesterol (TRL-C) levels, and on hospitalizations. All three post hoc analyses showed significant reductions in cardiovascular risk and outcomes in the populations studied. The data was presented at the European Society of Cardiology (ESC) Congress 2025 in Madrid, Spain.
鈥淭he REDUCE-IT data continue to yield important insights into the clinical utility of VASCEPA/VAZKEPA and how icosapent ethyl can reduce cardiovascular risk across diverse patient populations,鈥� said Deepak L. Bhatt, MD, MPH, MBA, Director of Mount Sinai Fuster Heart Hospital. 鈥淭hese new analyses reinforce the robustness of the original findings and highlight the potential of icosapent ethyl to address complex conditions like cardiovascular-kidney-metabolic syndrome and lipid-driven risk. The consistency of benefit observed across multiple high-risk subgroups supports its integration into contemporary treatment strategies as a complementary therapy aimed at improving patient outcomes.鈥�
Key findings from these post hoc analyses are outlined below:听
Icosapent Ethyl Reduces CVD Risk in Cardiovascular-Kidney-Metabolic Syndrome: REDUCE-IT CKM
Cardiovascular-kidney-metabolic syndrome is a recently defined disorder linking metabolic syndrome risk factors to chronic kidney disease and cardiovascular disease.鈥�
This analysis examined the incremental CVD risk of CKM in secondary prevention patients with metabolic syndrome but without diabetes at baseline (n=2860) and the effect of IPE therapy.鈥� Subjects were divided into four baseline estimated glomerular filtration rate (eGFR) groups: 鈮� 90, < 90, 鈮� 60, and < 60 mL/min/1.73 m2. IPE treatment vs placebo showed a statistically significant reduction in the primary composite endpoint (CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina) in eGFR groups < 60, 鈮� 60, and < 90. IPE treatment in the eGFR < 60 group showed a
The analysis showed that IPE treatment reduced CVD risk in patients with CKM syndrome, thereby supporting a role for this therapy in these high CVD risk patients.
Icosapent Ethyl Reduces Cardiovascular Risk Across Apolipoprotein B and Fasting Triglyceride Rich Lipoprotein Levels
Increased ApoB levels due to triglyceride rich听lipoproteins (TRL) are associated with increased cardiovascular risk, even when low-density听lipoprotein cholesterol (LDL-C) levels are well controlled.
This analysis assessed the impact of IPE on MACE (CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina) stratified by ApoB and fasting TRL-C. Relationships between quartiles of baseline ApoB concentration, baseline fasting TRL-C and risk for first MACE were analyzed.鈥�
IPE treatment resulted in significant听reductions in MACE, from the first through fourth baseline quartiles of ApoB: HR 0.72 (
This analysis showed that IPE significantly reduced MACE across all quartiles of baseline ApoB and TRL-C concentrations above the 25th percentile, supporting the use of IPE in patients with mild or moderate hypertriglyceridemia regardless of ApoB and TRL-C levels.
Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT
This analysis of REDUCE-IT estimated the effects of IPE treatment on total hospitalizations and days lost to hospitalization and death.鈥�
The analysis听showed that among participants in REDUCE-IT, IPE reduced total hospitalizations and had favorable impacts on measures of days lost due to hospitalization and death. 鈥婭PE significantly reduced total hospitalizations, HR 0.91 (
These findings provide additional insights on the effects of IPE on patient-centered measures of total disease burden.
Recommendation for High Dose Icosapent Ethyl Reaffirmed in ESC/EAS Dyslipidemias Guideline Focused Update as Class IIA Therapy in High-Risk or Very High-Risk Patients to Reduce Cardiovascular Events
In addition to the abstracts presented at ESC, use of icosapent ethyl was reaffirmed as a Class IIA recommendation within the ESC/EAS Dyslipidemias Guideline Focused Update. The guideline states, 鈥渢hat high-dose icosapent ethyl (as in the REDUCE-IT trial) should be considered for high-risk or very high-risk patients with elevated triglyceride levels (fasting triglyceride level 135鈥�499 mg/dL [1.52鈥�5.63 mmol/L]) despite statin therapy to lower CVD events.鈥� 鈥淲e were very pleased to see the maintenance of IPE class recommendation in this ESC/EAS focused dyslipidemia update based on our robust data from REDUCE-IT,鈥� said Steven Ketchum, Ph.D., EVP, President of R&D, and Chief Scientific Officer at Amarin. 鈥淭he focused update also states that, in contrast to the robust evidence of ASCVD risk reduction with LDL-C lowering therapies, the efficacy of triglyceride lowering with fibrates in reducing ASCVD risk has not been established, and that there has not been evidence that dietary supplementation with polyunsaturated fatty acids, including EPA+DHA mixtures, can lower LDL-C levels or reduce the risk of CV events.鈥�1
About Amarin
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.听 Amarin provided funding to Mount Sinai Hospital for Dr. Bhatt鈥檚 work on the above analyses.
About VASCEPA庐/VAZKEPA庐 (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鈥檚 initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (鈮�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 (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) 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 (鈮� 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 (鈮� 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 鈮�
3% and 鈮�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 CAN BE FOUND AT .
Europe
For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA庐 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鈥檚 key achievements in 2024 and the potential impact and outlook for achievements in 2025 and beyond; Amarin鈥檚 2025 financial outlook and cash position; Amarin鈥檚 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鈥檚 quarterly report on Form 10-Q for the period ending June 30, 2025 and annual report on Form 10-K for the fiscal year ended 2024. 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鈥檚 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 (www.amarincorp.com), the investor relations website (www.amarincorp.com/investor-relations) including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts
Availability of Other Information About Amarin
Amarin communicates with its investors and the public using the company website () and the investor relations website (), including but not limited to investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin鈥檚 investor relations website and may include social media channels. The contents of Amarin鈥檚 website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.听听
Amarin Contact Information
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1 Fran莽ois Mach, Konstantinos C Koskinas, Jeanine E Roeters van Lennep, Lale Tokg枚zo臒lu, Lina Badimon, Colin Baigent, Marianne Benn, Christoph J Binder, Alberico L Catapano, Guy G De Backer, Victoria Delgado, Natalia Fabin, Brian A Ference, Ian M Graham, Ulf Landmesser, Ulrich Laufs, Borislava Mihaylova, B酶rge Gr酶nne Nordestgaard, Dimitrios J Richter, Marc S Sabatine, ESC/EAS Scientific Document Group , 2025 Focused Update of the 2019 ESC/EAS Guidelines for the management of dyslipidaemias: Developed by the task force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS), European Heart Journal, 2025;, ehaf190,
FAQ
What were the key findings of AMRN's REDUCE-IT trial sub-analyses presented at ESC 2025?
How effective was VASCEPA/VAZKEPA in reducing hospitalizations according to the REDUCE-IT trial?
What is the new ESC/EAS guideline recommendation for icosapent ethyl in 2025?
What was the cardiovascular risk reduction in CKM syndrome patients treated with VASCEPA?
How did VASCEPA affect cardiovascular outcomes across different ApoB levels?
