5PSQ-018 Adequacy of omega-3-acid ethyl esters in patients with established cardiovascular diseases or cardiovascular risk factors
Year: 2025
Type: conference-paper
Abstract: Background and Importance Omega-3-acid ethyl esters (O3AEE) are indicated for the treatment of hypertriglyceridaemia, when diet and other non-pharmacological measures are not enough to reduce triglyceride levels. Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation (AF) in patients with established cardiovascular diseases (ECV) or cardiovascular risk factors (RCV) treated with O3AEE compared to placebo. The observed risk is highest with a dose of 4g/daily. European Medicines Agency (EMA) has recommended that the product information of these medicines should be updated to reflect data regarding the risk of AF. Aim and Objectives To analyse O3AEE prescriptions in adult patients with ECV or RCV after notification of EMA (November 2023), provide therapeutic recommendations if necessary and assess the level of acceptance. Material and Methods A prospective intervention study carried out in March 2024 at a University Hospital. Patients receiving treatment with O3AEE and an anticoagulant or other drug affecting coagulation (e.g. aspirin, warfarin and coumarin) were included. Electronic medical records were used to obtain the following data: sex, age, dosing regimen of O3AEE, comorbidities and life habits. Cardiovascular risk was calculated using the Framingham Risk Score. We recommend to the prescriber: 1) to discontinue O3AEE if the patient had AF; 2) to assess benefit-risk in patients with ECV or RCV, especially in those with a daily dose of O3AEE>4g. Results We identified 55 patients on O3AEE with ECV or RCV, 63.6% women with a mean age of 63.5±11.0 years. Clinical departments: 36.4% nephrology, 30.9% internal medicine, 14.5% cardiology, 9.1% endocrinology and 9.1% others. We recommended to discontinue O3AEE in seven patients with AF (71.4% accepted). Benefit-risk was assessed in 48 patients with ECV or RCV. Daily dose of O3AEE was >4g in 11 patients (22.9%). Treatment with O3AEE was discontinued in 17 patients (30.9%). Dose was reduced in seven patients (14.6%). Treatment was continued in 47.3%. Recommendations were accepted in 75% of nephrology patients, 52.9% internal medicine, 12.5% cardiology, 60% endocrinology, and 20% others. Conclusion and Relevance Most patients with AF have discontinued O3AEE treatment. However, despite the increased risk of AF in patients with ECV or RCV, prescribers have continued these medicines in almost half of patients. References and/or Acknowledgements Conflict of Interest No conflict of interest
Authors: MR Cantudo Cuenca, MDM García Valdés, B Gonzalez Sanchez, Á García López, A Jiménez Morales
Institution: Hospital Universitario Virgen de las Nieves
Language: English
Subfield: Nutrition and Dietetics
Field: Nursing
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408377147