Abstract 12542: Effectiveness of Icosapent Ethyl on First and Total Cardiovascular Events in the Metabolic Syndrome: REDUCE-IT MetSyn

Abstract

Introduction: The Metabolic Syndrome (MetSyn) is associated with persistently high risk of cardiovascular (CV) events despite statin treatment. Methods: REDUCE-IT was a multinational, double-blind trial that randomized 8179 high CV risk statin-treated patients with controlled low density lipoprotein cholesterol, and elevated triglycerides, to icosapent ethyl (IPE) 4 grams/day or placebo. In the overall trial, IPE reduced the risk of the primary composite endpoint (CV death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization or hospitalization for unstable angina) and the key secondary composite endpoint (CV death, nonfatal myocardial infarction or nonfatal stroke). Here we examine the prespecified patient subgroup with a history of MetSyn, but without diabetes at baseline. Results: Compared with placebo, IPE use in patients with MetSyn at baseline (n=2866) was associated with a 29% relative risk reduction for the primary composite endpoint (hazard ratio [HR], 0.71 [95% CI, 0.59-0.84]; P <0.0001, absolute risk reduction [ARR]=5.9%; number needed to treat [NNT]=17) and 41% reduction in total (first plus subsequent) events (rate ratio [RR], 0.59 [95% CI, 0.48-0.72]; P <0.0001) (Figure 1). The risk for the key secondary composite endpoint was reduced by 20% (P=0.05) with a 27% reduction in fatal/nonfatal 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 fatal/nonfatal stroke (27%), cardiac arrest (44%) and sudden cardiac death (34%). Conclusions: In statin-treated patients, the addition of IPE significantly reduced the risk of first and total CV events in REDUCE-IT patients with a history of MetSyn. The large relative and absolute risk reductions observed support IPE as a therapeutic consideration for high CV risk patients with MetSyn.