Effectiveness of icosapent ethyl on first and total cardiovascular events in patients with metabolic syndrome, but without diabetes: REDUCE-IT MetSyn

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-...

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Published in:European heart journal open 2023-11, Vol.3 (6), p.oead114-oead114
Main Authors: Miller, Michael, Bhatt, Deepak L, Brinton, Eliot A, Jacobson, Terry A, Steg, Philippe Gabriel, Pineda, Armando Lira, Ketchum, Steven B, Doyle, Jr, Ralph T, Tardif, Jean-Claude, Ballantyne, Christie M
Format: Article
Language:English
Subjects:
Cardiovascular diseases
Complications and side effects
Diagnosis
Drug therapy
Metabolic syndrome X
Original
Risk factors
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Summary: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). 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 ( = 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; < 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); < 0.0001] compared with placebo. The risk for the key secondary composite endpoint was reduced by 20% ( = 0.05) and a 27% reduction in fatal/non-fatal MI ( = 0.03), 47% reduction in urgent/emergent revascularization ( < 0.0001), and 58% reduction in hospitalization for unstable angina ( < 0.0001). Non-statistically significant reductions were observed in cardiac arrest (44%) and sudden cardiac death (34%). 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. REDUCE-IT ClinicalTrials.gov number: NCT01492361.
ISSN:2752-4191
2752-4191
DOI:10.1093/ehjopen/oead114