OBJECTIVES:  The ongoing REDUCE-IT study is investigating the effects of the prescription omega-3 fatty acid icosapent ethyl as add-on therapy to statins on long-term cardiovascular (CV) events in high-risk patients with hyperlipidemia. The objective of this study was to examine real-world evidence on CV outcomes and health care resource utilization and costs in a patient population similar to REDUCE-IT. METHODS:  This was a retrospective administrative claims analysis using the Optum Research Database of medical and pharmacy claims data, enrollment information, laboratory results, and mortality data. Patients ≥45 years with documented diabetes and/or atherosclerotic CV disease (ASCVD), baseline statin usage, baseline triglycerides ≥150 mg/dL, and up to 5 years of available data for follow-up were included. Patients had continuous enrollment with medical and pharmacy coverage for 6 months of baseline and ≥6 months of follow-up. Evaluation parameters included use of fibrates and prescription omega-3 fatty acid products, statin titration patterns, rates of occurrence of first and subsequent major CV events, new chronic heart failure, transient ischemic attack, coronary revascularization, and quantification of health care costs and resource utilization. RESULTS:  This report describes the baseline characteristics of the study population: 27,471 patients were included and had these characteristics: mean (SD) age, 61.6 (9.6) years; 46.7% female; 41.2 months mean follow-up; 69.3% commercial insurance enrollees, 30.7% Medicare; 83.7% on statins only, 13.4% on statin+fibrate, 1.9% on statin+omega-3, 1.0% on statin+fibrate+omega-3. Most (85.0%) patients had diabetes, 29.1% had ASCVD, 2.1% had prior myocardial infarction, and 3.1% had prior stroke. CONCLUSIONS:  This real-world evidence study of patients with characteristics similar to those in REDUCE-IT identified more than 27,000 patients for an analysis that is well positioned to provide robust insight into medication patterns, CV events, health care costs and resource utilization, and the potential impact of icosapent ethyl therapy, based on the forthcoming REDUCE-IT results.