DUBLIN and BRIDGEWATER, N.J., Nov. 09, 2025 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular care, today highlighted a new post hoc analysis of aspirin use in REDUCE-IT® reinforcing that icosapent ethyl significantly reduced cardiovascular (CV) events in high-risk patients. These findings highlight the importance of guideline-directed therapies and further validate the role of icosapent ethyl in comprehensive CV risk management in appropriate patients as studied in REDUCE-IT. This analysis was presented soon after the U.S. Food and Drug Administration (FDA) updated labeling for fenofibrate (fibrates) products that now include language on the neutral PROMINENT trial, reinforcing the lack of CV benefit when fibrates were used alongside statins for cardiovascular risk reduction; a pivotal moment that underscores the need for more effective, evidence-based approaches to residual CV risk.
“Data presented at AHA are the direct result of our continued investments in supporting our VASCEPA/VAZKEPA franchise and reaffirm our commitment to advancing the science of cardiovascular care and addressing the very real issue of residual risk in patients worldwide. Cardiovascular disease continues to be the leading cause of death globally, and far too many high-risk patients are in urgent need of protection now. That is why we remain committed to raising awareness among healthcare providers, payers, and patients about the importance of using FDA-approved therapies for cardiovascular risk reduction, such as VASCEPA® (icosapent ethyl) — proven to reduce cardiovascular events — on top of statin therapy in patients with elevated triglycerides,” said Steven Ketchum, Ph.D., EVP, President of R&D, and Chief Scientific Officer at Amarin. “The updated FDA labeling for fibrates is a critical development for clinicians seeking to reduce residual risk in their patients. The recent label update for fibrates – prompted by a citizen petition led by HealthyWomen – now clearly states that fibrates do not reduce cardiovascular risk when used in combination with statins based on the neutral PROMINENT trial safety and efficacy data where a fibrate was added to statins in patients with diabetes who had high triglycerides and low HDL-C. The revised indication limits fibrate use only to reduce triglyceride levels in adults with severe hypertriglyceridemia or for LDL-C reduction in adults with primary hyperlipidemia when statin therapy is not possible. We must continue to reinforce the message that fibrates offer no added cardiovascular benefit over statins and the importance of treating patient outcomes.”
“REDUCE-IT data continue to yield important insights into the clinical utility of icosapent ethyl and how it can reduce cardiovascular risk across diverse patient populations,” said Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital in New York. “The new REDUCE-IT post hoc analyses continue to support the primary outcomes datai,ii and allow us to further substantiate icosapent ethyl’s ability to reduce cardiovascular risk with or without aspirin use – an important evidence gap given the potential overlapping antiplatelet effects.iii In addition, the cardioprotective properties of icosapent ethyl are further supported by mechanistic insights into the anti-inflammatory and endothelial-protective effects of eicosapentaenoic acid.iv This important therapy has consistently demonstrated cardioprotective benefits across diverse patient populations, including those at high risk with a history of myocardial infarction or stroke, or an acute coronary syndrome population based on recent publications.v,vi,vii These findings further support the role of icosapent ethyl as a valuable option in comprehensive cardiovascular risk management.”
Key findings from the post hoc analysis are outlined below:
Efficacy of Icosapent Ethyl for Cardiovascular Risk Reduction by Aspirin Use in REDUCE-IT
A new analysis from the REDUCE-IT study reinforces the cardiovascular (CV) benefits of icosapent ethyl, a purified form of eicosapentaenoic acid, in patients with elevated triglycerides and controlled LDL-C who are at increased CV risk. The study explored outcomes among patients with and without concurrent aspirin use — an important consideration given potential overlapping antiplatelet effects.
Among 8,179 statin-treated participants, a cohort of 6,179 (75.5%) received aspirin at baseline. Icosapent ethyl significantly reduced major adverse CV events compared with placebo, with consistent benefits observed in both aspirin users and non-users. Among aspirin users, icosapent ethyl significantly reduced primary endpoint events (CV death, nonfatal MI, nonfatal stroke, coronary revascularization, or unstable angina) by 28% (P<0.0001), with absolute risk reduction (ARR) of 5.9% and number needed to treat (NNT) of 17. In this cohort, total (first plus subsequent) primary composite endpoint events were reduced by 36%, Rate Ratio (RR) 0.64 (95% CI: 0.56, 0.74); P<0.0001. Notably, among the subgroup of 4,867 aspirin users in the secondary prevention cohort, icosapent ethyl similarly reduced total primary endpoint events by 39%, RR 0.61 (95% CI: 0.53, 0.70); P
