Real-world use of Omega-3 fatty acids: a population-based study in an Italian local health unit from Northern Italy

Background and aims: Patients with atherosclerotic cardiovascular disease (ASCVD) often remain at high residual cardiovascular risk despite achieving target low-density lipoprotein cholesterol (LDL-C) levels, frequently due to persistent hypertriglyceridemia. While omega-3 fatty acids (EPA/DHA) are widely prescribed, recent trials and updated EAS/ESC guidelines support cardiovascular benefit only for purified Icosapent Ethyl (IPE). This study evaluated the real-world use of EPA/DHA in Italy. Methods and results: We conducted a retrospective observational study using administrative claims data from the Val Padana Local Health Unit (LHU) database (2022-2024). All individuals with at least one EPA/DHA dispensing were identified. Lipid-lowering therapy (LLT) users were assessed, and the EPA/DHA cohort was characterized by demographics, cardiovascular (CV) prevention setting (primary vs. secondary), treatment regimen (monotherapy or combination), and switching patterns. Among 669,292 residents, 23.1% received LLT; of these, 7.9% were prescribed EPA/DHA, corresponding to 1.2% of the overall population. Most EPA/DHA users were men aged 45-79 years, and more than half were in secondary CV prevention. Although combination therapy was common, overall 38.2% received EPA/DHA as monotherapy, including over 29% of secondary CV prevention patients. Switching from other LLTs, mainly statins, occurred in 16.6% of secondary CV prevention users, suggesting inappropriate use of EPA/DHA as a substitute for statin therapy. Conclusions: EPA/DHA were frequently prescribed outside current guideline recommendations, particularly as monotherapy in high-risk secondary CV prevention patients. These findings highlight a gap between evidence-based guidance and clinical practice and emphasize the need to improve prescribing appropriateness.