Related Experiment Video
Updated: Jun 23, 2026

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
Published on: April 23, 2019
Comparison of product label vs real-world safety data from branded icosapent ethyl users: A select analysis utilizing
John R Nelson1, Richard A Hansen1, Handrean Soran1
1California Cardiovascular Institute, Fresno, CA, USA (Dr Nelson); Independent Real World Evidence Consultant, Athens, GA, USA (Dr Hansen); Manchester University Hospital NHS Foundation Trust, Manchester, United Kingdom (Dr Soran); Amarin Pharma, Inc., Bridgewater, NJ, USA (Drs Justice, Abrahamson, Hannachi, Philip); Amarin Pharma, Inc., Zug, Switzerland (Drs Justice, Abrahamson, Hannachi, Philip); Clinical Research and Adult Diabetes sections, Joslin Diabetes Center, Department of Medicine, Harvard Medical School, Boston, MA, USA (Dr Ganda); Tehran Heart Center, Cardiovascular Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (Dr Hosseini).
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 postmarketing 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.
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