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Brian Olshansky, Tel: +1 319 384 8756, Email: brian-olshansky@uiowa.edu

B.O. served as Chair of the Data Safety Monitoring Committee (DMC) of REDUCE-IT. He is presently a consultant for Amarin, Respicardia, Sanofi Aventis, Lundbeck and serves as United States co-coordinator for GLORIA-AF sponsored by Boehringer Ingelheim. D.L.B. serves as the Chair and International Principal Investigator for REDUCE-IT, with research funding from Amarin to Brigham and Women’s Hospital. D.L.B. discloses the following relationships—Advisory Board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, Level Ex, Medscape Cardiology, PhaseBio, PLx Pharma, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), 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), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Vice-Chair, ACC Accreditation Committee), 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), 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, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA 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); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Idorsia, Ironwood, Ischemix, Lexicon, Lilly, Medtronic, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi Aventis, Synaptic, The Medicines Company; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Novo Nordisk, Takeda. M.M. received consulting fees from Amarin, Pfizer, and 89bio. G.S. 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.

E.A.B. received fees as a speaker from Amarin, Amgen, Esperion, and Medicure, and consulting fees from Amarin, Amgen, Esperion, and Medicure. T.A.J. received consulting fees from Amgen, Esperion, Novartis, Regeneron, and Sanofi. S.B.K. is an employee and stockholder of Amarin Pharma, Inc. R.T.D. is an employee and stockholder of Amarin Pharma, Inc. R.A.J. is an employee and stockholder of Amarin Pharma, Inc. L.J. is an employee and stockholder of Amarin Pharma, Inc. C.G. is an employee and stockholder of Amarin Pharma, Inc. J.-C.T. received grant support from Amarin, AstraZeneca, Esperion, Ionis, and RegenXBio; grant support and consulting fees from DalCor; grant support and fees for serving on an executive committee from Sanofi; grant support and consulting fees from Servier; and holding a minor equity interest in DalCor and patents (US 9 909 178 B2) on dalcetrapib for therapeutic use and on use of colchicine after myocardial infarction. C.M. is an employee of Cytel, Incorporated. R.M. is an employee of Cytel, Incorporated. C.M.B. received consulting fees from Arrowhead, AstraZeneca, Eli Lilly, Matinas BioPharma, Merck, Boehringer Ingelheim, Novo Nordisk, Denka Seiken, and Gilead and grant support (paid to his institution) and consulting fees from Amarin, Amgen, Esperion, Novartis, Regeneron, Sanofi-Synthelabo, and Akcea. No other potential conflict of interest relevant to this article was reported. M.K.C. served on the Amarin DMC but has no relevant financial disclosures.

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Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Cardiac & Cardiovascular Systems
  • Pharmacology & Pharmacy
  • Cardiovascular System & Cardiology

REDUCE-IT INTERIM: accumulation of data across prespecified interim analyses to final results

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Journal Title:

EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY

Volume:

Volume 7, Number 3

Publisher:

, Pages E61-E63

Type of Work:

Article | Final Publisher PDF

Abstract:

REDUCE-IT was designed as a randomized, placebo-controlled, cardiovascular outcomes trial of patients treated with statins, who had controlled low-density lipoprotein cholesterol, but persistently elevated triglycerides, along with overt presence of or high risk for cardiovascular disease.1 Participants across 11 countries were randomized to receive icosapent ethyl, a highly purified form of eicosapentaenoic acid, 2 g twice daily or placebo and followed for a median of 4.9 years (maximum 6.2 years). The primary endpoint was time from randomization to first occurrence of a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or unstable angina requiring hospitalization. The key secondary endpoint was time from randomization to first occurrence of a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.

Copyright information:

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.

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