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Brian Olshansky, MD, Division of Cardiology, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, IA 52242. Email: brian-olshansky@uiowa.edu

The authors thank the investigators, the study coordinators, and especially the patients who participated in REDUCE‐IT.

Dr Olshansky served as chairman of the Data Monitoring Committee of REDUCE‐IT and is a consultant for Amarin. He is a member of a Data Monitoring Committee for AstraZeneca and has been a consultant for Sanofi Aventis and Boehringer Ingelheim.

Dr Bhatt serves as the Chair and International Principal Investigator for REDUCE‐IT, with research funding from Amarin to Brigham and Women's Hospital. Dr Bhatt discloses the following relationships: Advisory Board: AngioWave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences, Stasys; Board of Directors: AngioWave (stock options), Boston VA Research Institute, Bristol Myers Squibb (stock), DRS.LINQ (stock options), High Enroll (stock), Society of Cardiovascular Patient Care, TobeSoft; Chair: Inaugural Chair, American Heart Association Quality Oversight Committee; Consultant: Broadview Ventures; Data Monitoring Committees: Acesion Pharma, Assistance Publique‐Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic (including for the ExCEED trial, funded by Edwards), Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY‐DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the National Institutes of Health–funded MINT trial); Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol‐Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE‐DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS‐II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co‐Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and US national co‐leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today's Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees), Wiley (steering committee); Other: Clinical Cardiology (Deputy Editor), NCDR‐ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Patent: Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; neither I nor Brigham and Women's Hospital receive any income from this patent.); Research Funding: Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol‐Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, 89Bio; Royalties: Elsevier (Editor, Braunwald's Heart Disease); Site Co‐Investigator: Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Takeda.

Dr Miller received consulting fees from Amarin, Pfizer, and 89bio. Dr Steg received research grant funding from Amarin, Bayer, Merck, Sanofi, and Servier; speaking or consulting fees from Amarin, Amgen, AstraZeneca, Bayer/Janssen, Boehringer Ingelheim, Bristol‐Myers‐Squibb, Idorsia, Lilly, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, and Servier. Dr Brinton received fees as a speaker from Amarin, Amgen, Amryt, and Esperion, and consulting fees from Amarin, Amgen, Amryt, DelCor, Esperion, 89bio, Immunovant, Ionis, Merck, NovoNordisk, and Pfizer. Dr Jacobson received consulting fees from Amgen, Esperion, Novartis, Regeneron, and Sanofi. Dr Ketchum is an employee and stockholder of Amarin Pharma, Inc. R. T. Doyle is an employee and stockholder of Amarin Pharma, Inc. Dr Juliano is a former employee and stockholder of Amarin Pharma, Inc. Dr Jiao is a former employee and stockholder of Amarin Pharma, Inc. Dr Kowey is a consultant for Amarin and Glaxo SmithKline. Dr Reiffel is an investigator for Medtronic, Janssen, and Sanofi, a consultant for Medtronic, Sanofi‐Aventis, Acesion, Correvio, and Amarin, and has served on a speakers' bureau for Sanofi‐Aventis.

Dr Tardif reports grants from Amarin, AstraZeneca, Ceapro, DalCor Pharmaceuticals, Esperion, Ionis, Novartis, Pfizer and RegenXBio; honoraria from AstraZeneca, DalCor Pharmaceuticals, HLS Pharmaceuticals, Pendopharm and Pfizer; minor equity interest in DalCor Pharmaceuticals; and patents on pharmacogenomics‐guided CETP inhibition and use of colchicine after myocardial infarction. Dr Ballantyne reports grant/research support‐ all significant and paid to institution, not individual: Abbott Diagnostic, Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, Novartis, Novo Nordisk, Regeneron, Roche Diagnostic, NIH, AHA, ADA. Consultant‐ 89Bio, Abbott Diagnostics, Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, Astra Zeneca, Denka Seiken*, Esperion, Genentech, Gilead, Illumina, Ionis, Matinas BioPharma Inc, Merck, New Amsterdam*, Novartis, Novo Nordisk, Pfizer, Regeneron, Roche Diagnostic *Significant where noted (〉$10,000); remainder modest (〈$10,000). Dr Chung was a member of the Data Monitoring Committee of REDUCE‐IT.

Subject:

Research Funding:

The main REDUCE‐IT trial and this analysis have been funded by Amarin.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Cardiovascular System & Cardiology
  • atrial fibrillation
  • bleeding
  • eicosapentaenoic acid
  • icosapent ethyl
  • prevention
  • POLYUNSATURATED FATTY-ACID
  • FISH-OIL
  • ISCHEMIC EVENTS
  • OMEGA-3-FATTY-ACIDS
  • SUPPLEMENTATION
  • HEART
  • BLOCK
  • ELECTROPHYSIOLOGY
  • ARRHYTHMIAS
  • PREVENTION

Cardiovascular Benefits of Icosapent Ethyl in Patients With and Without Atrial Fibrillation in REDUCE-IT

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Journal Title:

JOURNAL OF THE AMERICAN HEART ASSOCIATION

Volume:

Volume 12, Number 5

Publisher:

, Pages e026756-e026756

Type of Work:

Article | Final Publisher PDF

Abstract:

BACKGROUND: In REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl–Intervention Trial), icosapent ethyl (IPE) versus placebo) reduced cardiovascular death, myocardial infarction, stroke, coronary revascularization, or unstable angina requiring hospitalization, but was associated with increased atrial fibrillation/atrial flutter (AF) hospitalization (3.1% IPE versus 2.1% placebo; P=0.004). METHODS AND RESULTS: We performed post hoc efficacy and safety analyses of patients with or without prior AF (before randomi-zation) and with or without in-study time-varying AF hospitalization to assess relationships of IPE (versus placebo) and outcomes. In-study AF hospitalization event rates were higher in patients with prior AF (12.5% versus 6.3%, IPE versus placebo; P=0.007) versus without prior AF (2.2% versus 1.6%, IPE versus placebo; P=0.09). Serious bleeding rates trended higher in patients with (7.3% versus 6.0%, IPE versus placebo; P=0.59) versus without prior AF (2.3% versus 1.7%, IPE versus placebo; P=0.08). With IPE, serious bleeding trended higher regardless of prior AF (interaction P value [Pint ]=0.61) or postrandomization AF hospitalization (Pint =0.66). Patients with prior AF (n=751, 9.2%) versus without prior AF (n=7428, 90.8%) had similar relative risk reductions of the primary composite and key secondary composite end points with IPE versus placebo (Pint =0.37 and Pint =0.55, respectively). CONCLUSIONS: In REDUCE-IT, in-study AF hospitalization rates were higher in patients with prior AF especially in those randomized to IPE. Although serious bleeding trended higher in those randomized to IPE versus placebo over the course of the study, serious bleeding was not different regardless of prior AF or in-study AF hospitalization. Patients with prior AF or in-study AF hospitalization had consistent relative risk reductions across primary, key secondary, and stroke end points with IPE. REGISTRATION: URL: https://clinicaltrials.gov/ct2/show/NCT01492361; Unique Identifier: NCT01492361.

Copyright information:

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/).
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