Effectiveness of Icosapent Ethyl on First and Total Cardiovascular Events in Patients With Metabolic Syndrome, but Without Diabetes: REDUCE-IT MetSyn

Authors

• Michael Miller
• Deepak L Bhatt
• Eliot A Brinton
• Terry A Jacobson
• Philippe Gabriel Steg
• Armando Lira Pineda
• Steven B Ketchum
• Ralph T Doyle
• Jean-Claude Tardif
• Christie M Ballantyne

Language

English

Publication Date

11-1-2023

Journal

European Heart Journal Open

DOI

10.1093/ehjopen/oead114

PMID

38035037

PMCID

PMC10684296

PubMedCentral® Posted Date

11-12-2023

PubMedCentral® Full Text Version

Post-print

Abstract

Aims: Metabolic syndrome (MetSyn) is associated with high risk of cardiovascular (CV) events, irrespective of statin therapy. In the overall REDUCE-IT study of statin-treated patients, icosapent ethyl (IPE) reduced the risk of the primary composite endpoint (CV death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, or unstable angina requiring hospitalization) and the key secondary composite endpoint (CV death, non-fatal myocardial infarction, or non-fatal stroke).

Methods and results: REDUCE-IT was an international, double-blind trial that randomized 8179 high CV risk statin-treated patients with controlled LDL cholesterol and elevated triglycerides, to IPE 4 g/day or placebo. The current study evaluated the pre-specified patient subgroup with a history of MetSyn, but without diabetes at baseline. Among patients with MetSyn but without diabetes at baseline (n = 2866), the majority (99.8%) of this subgroup was secondary prevention patients. Icosapent ethyl use was associated with a 29% relative risk reduction for the first occurrence of the primary composite endpoint [hazard ratio: 0.71; 95% confidence interval (CI): 0.59-0.84; P < 0.0001, absolute risk reduction (ARR) = 5.9%; number needed to treat = 17] and a 41% reduction in total (first plus subsequent) events [rate ratio: 0.59; (95% CI: 0.48-0.72); P < 0.0001] compared with placebo. The risk for the key secondary composite endpoint was reduced by 20% (P = 0.05) and a 27% reduction in fatal/non-fatal MI (P = 0.03), 47% reduction in urgent/emergent revascularization (P < 0.0001), and 58% reduction in hospitalization for unstable angina (P < 0.0001). Non-statistically significant reductions were observed in cardiac arrest (44%) and sudden cardiac death (34%).

Conclusion: In statin-treated patients with a history of MetSyn, IPE significantly reduced the risk of first and total CV events in REDUCE-IT. The large relative and ARRs observed supports IPE as a potential therapeutic consideration for patients with MetSyn at high CV risk. Registration REDUCE-IT ClinicalTrials.gov number: NCT01492361.

Keywords

Metabolic syndrome, Diabetes, Hypertension, Hypertriglyceridaemia, HDL-C, Icosapent ethyl, Obesity

Comments

This article has been corrected. See Eur Heart J Open. 2024 Mar 1;4(2):oeae004.

Published Open-Access

yes

Recommended Citation

Miller, Michael; Bhatt, Deepak L; Brinton, Eliot A; et al., "Effectiveness of Icosapent Ethyl on First and Total Cardiovascular Events in Patients With Metabolic Syndrome, but Without Diabetes: REDUCE-IT MetSyn" (2023). Faculty, Staff and Students Publications. 6696.
https://digitalcommons.library.tmc.edu/baylor_docs/6696