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Comparison of Product Label Vs Real-World Safety Data From Branded Icosapent Ethyl Users: A Select Analysis Utilizing Marketscan Data Publisher



Nelson JR1, 2, 3, 4, 5, 6, 7 ; Hansen RA1, 2, 3, 4, 5, 6, 7 ; Soran H1, 2, 3, 4, 5, 6, 7 ; Justice N1, 2, 3, 4, 5, 6, 7 ; Ganda OP1, 2, 3, 4, 5, 6, 7 ; Abrahamson D1, 2, 3, 4, 5, 6, 7 ; Hosseini K1, 2, 3, 4, 5, 6, 7 ; Hannachi H1, 2, 3, 4, 5, 6, 7 ; Philip S1, 2, 3, 4, 5, 6, 7
Authors

Source: Journal of Clinical Lipidology Published:2025


Abstract

Background: The REDUCE-IT trial demonstrated significant reductions in cardiovascular events with icosapent ethyl (IPE) treatment among patients with elevated triglyceride levels; however, patients on IPE experienced slightly more atrial fibrillation/flutter, bleeding, constipation, and peripheral edema events compared with patients receiving placebo. The real-world frequency of these events outside of trials and spontaneous post-marketing reports is unknown. Sources of material: The frequency of the events of interest with IPE was compared across the REDUCE-IT trial, product labels, and real-world evidence (RWE) estimates derived using the MarketScan Commercial Claims database. New IPE users were followed up to 4 years; events were identified from ICD-10 codes. Cumulative incidence of each event was compared across data sources. Abstract of findings: RWE estimates exhibited similar trends to the trial-based estimates; however, the RWE estimates consistently were one-third to one-fifth of the cumulative incidences reported in the REDUCE-IT trial or product label. Conclusion: IPE may be well tolerated in real-world settings. © 2025
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