Cross-sectional analysis of demographic and clinical characteristics of patients using icosapent ethyl

Abstract

Abstract Background/Introduction Icosapent ethyl (IPE) is an ethyl ester of eicosapentaenoic acid first approved in 2012 in the United States for the treatment of severe hypertriglyceridemia (triglyceride [TG] levels ≥500 mg/dL).1 Following results from the global REDUCE-IT trial in 2019 in which IPE substantially reduced the risk of cardiovascular (CV) events,2 IPE was approved in European countries and the United States to reduce the risk of CV events in adults treated with statins who have elevated TG levels (≥150 mg/dL) and established CV disease (CVD) or diabetes mellitus (DM) with additional risk factors for CVD.1,3 An estimated 3 million American adults are eligible to receive IPE for primary and secondary CVD prevention.4 Purpose Provide the first descriptive study of demographic and clinical characteristics of US patients taking IPE. Methods A database with electronic medical records of >89 million patients from 56 US health care organizations was used to identify those taking IPE, defined as those for whom at least 2 IPE prescriptions were documented (ie, on 2 separate dates). No specific date range or exclusion criteria were applied. Patient demographic information, prior/existing conditions, prior/concomitant medications, and laboratory data were retrieved. Results As of January 19, 2023, a total of 40,408 patients taking IPE were identified; they had a mean (SD) age of 60.3 years (12.9) and a body mass index of 31.9 kg/m2 (6.07). Most patients started taking IPE after January 1, 2019 (72.8%), were men (60.5%), White (75.2%), non-Hispanic or Latino (73.1%), and from the southern (46.0%) or northeastern (34.0%) United States (Table). In line with the indication of IPE, 65.3% had prior atherosclerotic CVD or DM and at least 1 risk factor. Common prior or existing conditions associated with those indicated for IPE treatment were DM (41.0%), coronary artery disease (30.2%), prior myocardial infarction (11.0%), prior stroke (7.4%), and severe hypertriglyceridemia (8.1%); hypertension (68.4%) and obesity (40.9%) were common comorbidities. Mean (SD; median) TG level in the 3 months before IPE initiation was 422 mg/dL (506; 300). Treatment with statins was very high (71.8%), and common other concomitant medications included anticoagulants (53.3%), antidiabetic agents (52.3%), and antiplatelets (46.0%; Table). Fibrates were used by 26.0% of patients taking IPE any time on or before IPE initiation. Conclusion(s) Patients using IPE commonly had a history of CVD, DM, or both, took statins, and had elevated levels of TG, thereby meeting the indication for IPE treatment. The high baseline TG levels in this population suggest that IPE is underutilized.