New REDUCE-IT® Findings Unveiled at ESC 2025 Reveal VASCEPA®/VAZKEPA® (Icosapent Ethyl) Therapy Leads to 9% Decrease in Total Hospitalizations and Lowers Cardiovascular Disease Risk in Specific High-Risk Patient Groups
2025 ESC/EAS Dyslipidemia Guideline Update
- High Dose Icosapent Ethyl Recommendation: The European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) reaffirmed high-dose icosapent ethyl (IPE) as a Class IIA recommended therapy for high-risk patients with elevated triglyceride levels (135–499 mg/dL) despite statin therapy, aimed at reducing cardiovascular disease (CVD) events.
REDUCE-IT Trial Insights
Impact on Cardiovascular-Kidney-Metabolic Syndrome: A post hoc analysis from the REDUCE-IT trial indicated that IPE significantly reduced cardiovascular risk in patients with cardiovascular-kidney-metabolic syndrome. In patients with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m², IPE treatment resulted in a 44% relative risk reduction for major cardiovascular events, with a number needed to treat (NNT) of 9.
Reduction in Major Adverse Cardiovascular Events (MACE): Another analysis showed that IPE significantly reduced MACE across various baseline apolipoprotein B (ApoB) and fasting triglyceride-rich lipoprotein cholesterol (TRL-C) levels. The hazard ratios for MACE decreased progressively across quartiles of ApoB and TRL-C, indicating consistent benefits regardless of lipid levels.
Hospitalization and Mortality Effects: IPE treatment was associated with a reduction in total hospitalizations (HR 0.91) and improved survival rates without hospitalization. The odds ratio for surviving until the end of the study without hospitalization was 1.12, and the rate of days lost due to hospitalization was significantly lower (RR 0.93).
Clinical Implications
Integration into Treatment Strategies: The findings from the REDUCE-IT trial analyses support the integration of IPE into contemporary treatment strategies for high-risk patients, particularly those with complex conditions like cardiovascular-kidney-metabolic syndrome.
Robust Evidence for IPE: The consistent benefits observed across diverse patient populations reinforce the clinical utility of IPE in reducing cardiovascular risk, highlighting its potential as a complementary therapy in managing lipid-driven risks.
About Amarin and VASCEPA
Company Overview: Amarin Corporation is focused on advancing cardiovascular disease management and has offices in multiple countries. VASCEPA (icosapent ethyl) is the first FDA-approved treatment for high-risk patients with persistent cardiovascular risk despite statin therapy, launched in the U.S. in January 2020.
Market Presence: Since its launch, VASCEPA has been prescribed over 25 million times and is covered by most major medical insurance plans. It is also approved in several countries, including Canada, China, and various European nations, under the brand name VAZKEPA.
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Amarin Advances VASCEPA with Over 25 Million Global Prescriptions and New Therapy Insights
- Global Prescription Volume: Amarin's VASCEPA®/VAZKEPA® has surpassed 25 million prescriptions worldwide, demonstrating its broad acceptance and efficacy in cardiovascular treatment, thereby solidifying the company's market leadership.
- Therapeutic Innovation: The emergence of new therapies is expected to expand the use of existing treatment options, including VASCEPA, helping to meet the needs of tens of millions of cardiovascular disease patients globally, thus enhancing patient access and treatment outcomes.
- Clinical Evidence Support: According to the 2018 REDUCE-IT study, VASCEPA demonstrated a 25% reduction in cardiovascular events when used in conjunction with statin therapy, providing robust clinical support for its application in cardiovascular risk management.
- Market Expansion Plans: Amarin has signed a long-term exclusive licensing agreement with Recordati S.p.A. to commercialize VAZKEPA across 59 countries, further enhancing its influence in the European market and expected to drive future sales growth.
Daily Upgrade Report for Validea Kenneth Fisher Strategy - December 9, 2025
Validea's Upgrade for AMRN: Validea's Price/Sales Investor model, based on Kenneth Fisher's strategy, upgraded Amarin Corporation PLC (AMRN) from 28% to 60% due to improved fundamentals and valuation, indicating growing interest in the stock.
Company Overview: Amarin Corporation is a pharmaceutical company focused on developing therapeutics for cardiovascular health, primarily through its lead product, Vascepa, which is used to reduce triglyceride levels in patients with severe hypertriglyceridemia.
Kenneth Fisher's Background: Kenneth Fisher, a prominent money manager and author, is known for popularizing the price/sales ratio as a stock evaluation tool and is the founder of Fisher Investments, located in a forest preserve to encourage independent thinking away from Wall Street.
Validea's Investment Research: Validea provides investment research based on the strategies of successful investors like Warren Buffett and Benjamin Graham, offering stock analysis and model portfolios aimed at long-term market outperformance.
