Investigators to Present New REDUCE-IT Subanalysis of VASCEPA®/VAZKEPA® (icosapent ethyl) in Patients With and Without Coronary Artery Disease History and Mechanistic Data on Eicosapentaenoic Acid (EPA) at the American Heart Association’s (AHA) Annual Scientific Sessions
Amarin (NASDAQ:AMRN) announced upcoming presentations of new REDUCE-IT trial subanalysis and mechanistic data at the American Heart Association's Scientific Sessions (November 16-18, 2024) in Chicago. The presentations will focus on VASCEPA®/VAZKEPA® (icosapent ethyl) effectiveness in patients with and without coronary artery disease (CAD) history.
Key presentations include cardiovascular risk reduction data in patients with prior cardiovascular events, EPA's antioxidant effects in endothelial cells, and EPA's impact on Lp(a) particle oxidation. The research highlights that approximately 20% of the global population is affected by high Lp(a) concentrations, which increase cardiovascular event risk by 2-4 times.
Amarin (NASDAQ:AMRN) ha annunciato le prossime presentazioni di nuove sottosezioni dell'analisi del trial REDUCE-IT e dati meccanistici durante le Sessioni Scientifiche dell'American Heart Association (16-18 novembre 2024) a Chicago. Le presentazioni si concentreranno sull'efficacia di VASCEPA®/VAZKEPA® (etile eicosapentanoico) in pazienti con e senza una storia di malattia coronarica (CAD).
Le presentazioni chiave includeranno dati sulla riduzione del rischio cardiovascolare in pazienti con eventi cardiovascolari pregressi, gli effetti antiossidanti dell'EPA nelle cellule endoteliali e l'impatto dell'EPA sull'ossidazione delle particelle Lp(a). La ricerca evidenzia che circa il 20% della popolazione globale è colpita da alte concentrazioni di Lp(a), che aumentano il rischio di eventi cardiovascolari da 2 a 4 volte.
Amarin (NASDAQ:AMRN) anunció las próximas presentaciones de nuevos subanálisis del ensayo REDUCE-IT y datos mecanicistas en las Sesiones Científicas de la Asociación Americana del Corazón (16-18 de noviembre de 2024) en Chicago. Las presentaciones se centrarán en la efectividad de VASCEPA®/VAZKEPA® (éster de icosapentano) en pacientes con y sin antecedentes de enfermedad arterial coronaria (CAD).
Las presentaciones clave incluirán datos sobre la reducción del riesgo cardiovascular en pacientes con eventos cardiovasculares previos, los efectos antioxidantes del EPA en células endoteliales y el impacto del EPA en la oxidación de partículas de Lp(a). La investigación destaca que aproximadamente el 20% de la población mundial se ve afectada por altas concentraciones de Lp(a), lo que aumenta el riesgo de eventos cardiovasculares de 2 a 4 veces.
아마린 (NASDAQ:AMRN)은 REDUCE-IT 시험의 새로운 하위 분석 및 기초 메커니즘 데이터를 미국심장협회의 과학 세션에서 (2024년 11월 16-18일) 시카고에서 발표할 예정이라고 발표했습니다. 발표는 관상동맥질환(CAD) 이력이 있는 환자와 없는 환자에서 VASCEPA®/VAZKEPA® (이코사펜 에틸)의 효과에 초점을 맞출 것입니다.
주요 발표 내용에는 이전 심혈관 사건이 있는 환자에서의 심혈관 위험 감소 데이터, 내피 세포에서의 EPA의 항산화 효과 및 Lp(a) 입자 산화에 대한 EPA의 영향이 포함됩니다. 연구는 약 20%의 전 세계 인구가 높은 Lp(a) 농도의 영향을 받으며, 이는 심혈관 사건의 위험을 2-4배 증가시킨다고 강조합니다.
Amarin (NASDAQ:AMRN) a annoncé les prochaines présentations de nouvelles sous-analyses de l'essai REDUCE-IT et de données mécanistes lors des Séances Scientifiques de l'American Heart Association (16-18 novembre 2024) à Chicago. Les présentations se concentreront sur l'efficacité de VASCEPA®/VAZKEPA® (éthyle icosapent) chez les patients avec et sans antécédents de maladie coronarienne (CAD).
Les présentations clés incluront des données sur la réduction du risque cardiovasculaire chez les patients ayant eu des événements cardiovasculaires antérieurs, les effets antioxydants de l'EPA sur les cellules endothéliales, et l'impact de l'EPA sur l'oxydation des particules Lp(a). La recherche souligne qu'environ 20 % de la population mondiale est touchée par de fortes concentrations de Lp(a), ce qui augmente le risque d'événements cardiovasculaires de 2 à 4 fois.
Amarin (NASDAQ:AMRN) hat die bevorstehenden Präsentationen neuer Subanalysen der REDUCE-IT-Studie und mechanistischer Daten bei den Wissenschaftlichen Sitzungen der American Heart Association (16.-18. November 2024) in Chicago angekündigt. Die Präsentationen werden sich auf die Wirksamkeit von VASCEPA®/VAZKEPA® (Icosapentethyl) bei Patienten mit und ohne Vorgeschichte von koronarer Herzkrankheit (KHK) konzentrieren.
Wichtige Präsentationen umfassen Daten zur Reduzierung des kardiovaskulären Risikos bei Patienten mit früheren kardiovaskulären Ereignissen, die antioxidativen Effekte von EPA in Endothelzellen und die Auswirkungen von EPA auf die Oxidation von Lp(a)-Partikeln. Die Forschung hebt hervor, dass etwa 20% der Weltbevölkerung von hohen Lp(a)-Konzentrationen betroffen sind, die das Risiko kardiovaskulärer Ereignisse um das 2- bis 4-fache erhöhen.
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DUBLIN and BRIDGEWATER, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that investigators will present an additional subgroup analysis from the landmark REDUCE-IT outcomes trial in patients with and without coronary artery disease (CAD) history and mechanistic data on eicosapentaenoic acid (EPA) at the American Heart Association’s Scientific Sessions, November 16-18, 2024 in Chicago, IL.
"The data to be presented at the AHA Scientific Sessions continues to affirm the clinical utility and value of VASCEPA®/VAZKEPA® (icosapent ethyl), not only in the overall REDUCE-IT trial population, but also across various subgroups analyzed to date," said Steve Ketchum, PhD, Chief Scientific Officer at Amarin. "Data presented at AHA will showcase new evidence from the REDUCE-IT CAD subanalysis, highlighting the benefits of VASCEPA/VAZKEPA in secondary prevention patients, with and without CAD history."
Dr. Ketchum further added, "Additional data to be featured at the AHA Scientific Sessions include research highlighting the mechanistic effects of EPA, particularly its antioxidant effects in endothelial cells and the ability of EPA to impact the oxidation of Lp(a) particles. High Lp(a) concentrations are associated with increased CV event risk, and people with high levels face a 2-4 times greater risk of having an early event. With about
"This latest research reinforces Amarin’s commitment to advancing cardiovascular care and enhancing the medical community’s understanding of the value, mechanism of action, and global potential of VASCEPA/VAZKEPA in reducing cardiovascular events in high-risk patients," concluded Dr. Ketchum.
Featured Amarin-supported abstracts to be presented by international academic collaborators at AHA Scientific Sessions 2024 include:
Moderated Digital Poster Presentations
- Substantial Cardiovascular Risk Reduction with Icosapent Ethyl in Patients with Prior Cardiovascular Events Regardless of Coronary Artery Disease History: REDUCE-IT CAD
-Presenter: Rahul Aggarwal, MD
-November 16th, 2:50-4:15 PM
-Location: Zone 3
- Eicosapentaenoic Acid (EPA) Increases Expression of Nrf2-mediated Antioxidant Response Element (ARE) and Heme Oxygenase-1 in Cytokine-Activated Endothelial Cells
-Presenter: R. Preston Mason, PhD
-November 18th, 2:50-4:15 PM
-Location: Zone 1, MDP 2
Poster Presentations
- Lipoprotein(a) [Lp(a)]-Enriched Plasma Undergoes More Rapid Oxidation than Small Dense LDL-Enriched Plasma that is Inhibited by Eicosapentaenoic Acid (EPA)
-Presenter: R. Preston Mason, PhD
-November 17th, 3:15-4:15 PM
-Location: Zone 1, Science & Technology Hall
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.
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.1 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
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 twenty 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, Lebanon and the United Arab Emirates. 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, Denmark, Finland, Austria, the UK, Spain and the Netherlands.
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 click here.
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 the potential for VASCEPA (marketed as VAZKEPA in Europe); beliefs about icosapent ethyl (IPE)’s role concerning appropriate patients suffering from cardiovascular disease (CVD) and potential population health impact, as well as general beliefs about the safety and effectiveness of VASCEPA. 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 full year ended 2023. 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. Availability of Other Information About Amarin communicates with its investors and the public using the company website (www.amarincorp.com) and the investor relations website (www.amarincorp.com/investor-relations), 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’s investor relations website and may include social media channels. The contents of Amarin’s 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.
Amarin Contact Information
Investor & Media Inquiries:
Mark Marmur
Amarin Corporation plc
PR@amarincorp.com
Investor.relations@amarincorp.com
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1 American Heart Association. Heart Disease and Stroke Statistics—2020 Update: A Report From the American Heart Association. Circulation. 2020;141:e139-e596.
2 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.
3Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
4 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.
FAQ
What new REDUCE-IT data will be presented at AHA 2024 for AMRN's VASCEPA?
When and where will Amarin (AMRN) present its latest VASCEPA research at AHA 2024?
What percentage of the global population is affected by high Lp(a) according to AMRN's research?