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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
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Authors Affiliations
  1. 1. California Cardiovascular Institute, Fresno, CA, United States
  2. 2. Independent Real World Evidence Consultant, Athens, GA, United States
  3. 3. Manchester University Hospital NHS Foundation Trust, Manchester, United Kingdom
  4. 4. Amarin Pharma, Inc., Bridgewater, NJ, United States
  5. 5. Amarin Pharma, Inc., Zug, Switzerland
  6. 6. Clinical Research and Adult Diabetes sections, Joslin Diabetes Center, Department of Medicine, Harvard Medical School, Boston, MA, United States
  7. 7. Tehran Heart Center, Cardiovascular Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran

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