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

• Type of Material: Article
• Authors: Brian Olshansky, University of Iowa Hospitals and Clinics; Deepak L Bhatt, Harvard Medical School; Michael Miller, University of Maryland; Gabriel Ph Steg, Hôpital Bichat, Assistance Publique, - Hôpitaux de Paris; Eliot A Brinton, Utah Lipid Center; Terry Jacobson, Emory University; Steven B Ketchum, Amarin Pharma Inc; Ralph T Doyle Jr, Amarin Pharma Inc; Rebecca A Juliano, Amarin Pharma Inc; Lixia Jiao, Amarin Pharma Inc; Craig Granowitz, Amarin Pharma Inc; Jean-Claude Tardif, Université de Montréal; Cyrus Mehta, Cytel Inc; Rajat Mukherjee, Cytel Inc; Christie M Ballantyne, Baylor College of Medicine; Mina K Chung, Case Western Reserve University
• Language: English
• Date: 2021-05-23
• Publisher: OXFORD UNIV PRESS
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1093/ehjcvp/pvaa118
• Title of Journal or Parent Work: EUROPEAN HEART JOURNAL-CARDIOVASCULAR PHARMACOTHERAPY
• Volume: 7
• Issue: 3
• Start Page: E61
• End Page: E63
• Keywords: Life Sciences & Biomedicine; Science & Technology; Cardiovascular System & Cardiology; Pharmacology & Pharmacy; Cardiac & Cardiovascular Systems
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Epidemiology; Health Sciences, Public Health

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.