Amarin Corporation plc announced upcoming presentations at the European Society of Cardiology (ESC) Congress 2025, taking place August 29th-September 1st in Madrid, Spain, where new data will illuminate the multifaceted cardioprotective effects of icosapent ethyl (IPE). The presentations will provide deeper insight into IPE's potential role in reducing cardiovascular risk through multiple mechanisms, including effects on inflammation, lipoprotein oxidation, cardiovascular risk associated with cardiovascular-kidney-metabolic (CKM) syndrome, and risk and duration of hospitalizations.
New REDUCE-IT Post Hoc Analyses
The featured data includes new analyses from the REDUCE-IT trial evaluating the clinical benefit of IPE, alongside mechanistic studies investigating the impact of eicosapentaenoic acid (EPA) on inflammasome activation, lipoprotein(a) [Lp(a)] oxidation, and pro-inflammatory protein expression in endothelial cells under conditions of oxidative stress.
"The data being featured at ESC continue to reinforce the clinical value of IPE in reducing cardiovascular risk across specific patient subtypes," said Steven Ketchum, Ph.D., EVP, President of R&D, and Chief Scientific Officer at Amarin. "These new REDUCE-IT post hoc analyses not only support the primary outcomes data but also provide important, hypothesis-generating insights into the impact of IPE on the risk and duration of hospitalizations, CV risk associated with CKM syndrome, and major adverse CV event (MACE) endpoint stratified by apolipoproteinB (ApoB) and triglyceride-rich lipoprotein-cholesterol (TRL-C) levels."
Mechanistic Research Findings
The mechanistic findings include the effects of EPA on Lp(a) oxidation, pro-inflammatory protein expression in endothelial cells, and on modulating the activation of the NLRP3 inflammasome. According to Ketchum, these results advance understanding of the underlying science of this molecule and deepen the medical community's understanding of the role of IPE in cardiovascular care and its potential mechanisms of action.
ESC Congress 2025 Presentations
Amarin's presentations will include both oral presentations and moderated poster presentations. The company will also support educational programming addressing residual cardiovascular risk by medical and scientific leaders in Europe.
Moderated Poster Presentations
Key presentations include "Icosapent Ethyl Reduces CVD Risk in Cardiovascular-Kidney-Metabolic Syndrome: REDUCE-IT CKM" by Michael Miller and colleagues, available August 29th at 16:15 CET. Another presentation, "Icosapent Ethyl Reduces Cardiovascular Risk Across Apolipoprotein B and Fasting Triglyceride Rich Lipoprotein Levels" by Waqas A. Malick and colleagues, will be available August 30th at 8:15 CET.
A mechanistic study titled "Eicosapentaenoic Acid (EPA) Inhibited Lipoprotein(a) [Lp(a)] Oxidation and its Effects on Expression of Oxidative Stress and Pro-Inflammatory Proteins in Endothelial Cells" by Samuel C.R. Sherratt and colleagues will be presented August 29th at 13:15 CET.
Oral Presentations
Two oral presentations are scheduled, including "Effects of Icosapent Ethyl on Risk and Duration of Hospitalizations and Death in REDUCE-IT" by Michael Szarek and colleagues on August 30th at 8:15 CET. The second oral presentation, "Eicosapentaenoic Acid (EPA) Modulates Inflammasome Activation in Monocyte-derived Macrophages Isolated from Individuals with and Without Established Atherosclerotic Cardiovascular Disease (ASCVD)" by Joanna K Ward and colleagues, is scheduled for August 31st at 14:30 CET.
About VASCEPA/VAZKEPA
VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration 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 studied high-risk patients with persistent cardiovascular risk despite being on statin therapy.
Since launch, VASCEPA has been prescribed more than twenty-five million times and 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, marketing authorization was granted to icosapent ethyl in March 2021 for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.
Clinical Indications and Safety Profile
In the United States, 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 levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
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 drug was also associated with an increased risk (12% vs 10%) of bleeding in clinical trials. Common adverse reactions in the cardiovascular outcomes trial included musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
