New Analysis reinforces Vascepa/Vaskepa (icosapent ethyl) reduced cardiovascular events in high-risk patients – Amarin

Amarin Corporation 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 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.

Key findings from the post hoc analysis :

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<0.0001). The safety profile of icosapent ethyl in aspirin users was consistent with the overall study population.

The analysis showed that icosapent ethyl provides CV protection beyond standard therapy with statins and aspirin, without incremental safety concerns, addressing a key evidence gap and supporting the role of icosapent ethyl in comprehensive CV risk management.

“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. The new REDUCE-IT post hoc analyses continue to support the primary outcomes data 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. 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. 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. These findings further support the role of icosapent ethyl as a valuable option in comprehensive cardiovascular risk management.” -Deepak L. Bhatt, MD, MPH, MBA, Director of the Mount Sinai Fuster Heart Hospital in New York