John R Nelson, Richard A Hansen, Handrean Soran, Nilima Justice, Om P Ganda, David Abrahamson, Kaveh Hosseini, Hakima Hannachi, Sephy Philip
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引用次数: 0
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.
期刊介绍：
Because the scope of clinical lipidology is broad, the topics addressed by the Journal are equally diverse. Typical articles explore lipidology as it is practiced in the treatment setting, recent developments in pharmacological research, reports of treatment and trials, case studies, the impact of lifestyle modification, and similar academic material of interest to the practitioner.
Sections of Journal of clinical lipidology will address pioneering studies and the clinicians who conduct them, case studies, ethical standards and conduct, professional guidance such as ATP and NCEP, editorial commentary, letters from readers, National Lipid Association (NLA) news and upcoming event information, as well as abstracts from the NLA annual scientific sessions and the scientific forums held by its chapters, when appropriate.
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