Comparison of product label vs real-world safety data from branded icosapent ethyl users: a select analysis utilizing MarketScan data

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. 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. 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. IPE may be well tolerated in real-world settings.