期刊
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
卷 79, 期 17, 页码 1660-1671出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2022.02.035
关键词
clinical trials; icosapent ethyl; ischemic events; myocardial infarction
资金
- Amarin Pharma, Inc.
- Amarin
- Abbott
- Edwards
- Daiichi-Sankyo
- Boehringer Ingelheim
- CSL Behring
- Ferring Pharmaceuticals
- Bayer
- Afimmune
- Amgen
- AstraZeneca
- Bristol Myers Squibb
- Cardax
- CellProthera
- Cereno Scientific
- Chiesi
- Eisai
- Ethicon
- Faraday Pharmaceuticals
- Forest Laboratories
- Fractyl
- Garmin
- HLS Therapeutics
- Idorsia
- Ironwood
- Ischemix
- Janssen
- Javelin
- Lexicon
- Lilly
- Medtronic
- MyoKardia
- NirvaMed
- Novartis
- Novo Nordisk
- Owkin
- Pfizer
- PhaseBio
- PLx Pharma
- Regeneron
- Reid Hoffman Foundation
- Roche
- Sanofi
- Stasys
- Synaptic
- Medicines Company
- 89Bio
- Servier
- Merck
- Esperion
- Ionis
- DalCor
This study examined the benefit of Icosapent ethyl (IPE) on ischemic events among patients with prior myocardial infarction (MI) in the REDUCE-IT trial. The results showed that IPE treatment significantly reduced the primary endpoint, including cardiovascular death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina.
BACKGROUND REDUCE-IT was a double-blind trial that randomized 8,179 statin-treated patients with controlled low-density lipoprotein cholesterol and moderately elevated triglycerides to Icosapent ethyl (IPE) or placebo. There was a significant reduction in the primary endpoint, including death from cardiovascular (CV) causes. The specific impact of IPE among patients with prior myocardial infarction (MI) was unknown. OBJECTIVES Our goat was to examine the benefit of IPE on ischemic events among patients with prior MI in REDUCE-IT. METHODS We performed post hoc analyses of patients with prior MI. The primary endpoint was CV death, MI, stroke, coronary revascularization, or hospitalization for unstable angina. The key secondary endpoint was CV death, MI, or stroke. RESULTS A total of 3,693 patients had a history of prior ML The primary endpoint was reduced from 26.1% to 20.2% with IPE vs placebo; HR: 0.74 (95% CI: 0.65-0.85; P 0.00001). The key secondary endpoint was reduced from 18.0% to 13.3%; HR: 0.71 (95% 0: 0.61-0.84; P 0.00006). There was also a significant 35% relative risk reduction in total ischemic events (P = 0.0000001), a 34% reduction in MI (P = 0.00009), a 30% reduction in CV death (P = 0.01), and a 20% tower rate of alt-cause mortality (P = 0.054), although there was a slight increase in atrial fibrillation. Sudden cardiac death and cardiac arrest were also significantly reduced by 40% and 56%, respectively. CONCLUSIONS Patients with a history of prior MI in REDUCE-IT treated with IPE demonstrated large and significant relative and absolute risk reductions in ischemic events, including CV death. (A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. [REDUCE-IT]; NCT01492361) (C) 2022 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
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