EP-031 - PHARMACOKINETIC INTERACTION OF OMEGA-3 FATTY ACID 4 G AND ATORVASTATIN 40 MG.

J. Kim¹, J. Song¹, Y. Seo¹, W. Jung², K. Nam², Y. Kim², H. Lee³, J. Moon³, J. Jung¹, J. Hong¹, J. Sunwoo¹; ¹Chungnam National University Hospital, Daejeon, Republic of Korea, ²Korea United Pharm., Inc., Seoul, Republic of Korea, ³Caleb Multilab., Inc., Seoul, Republic of Korea.

Background: The efficacy of omega-3 fatty acid (OM3) and statin co-administration is controversial [1]. This study was conducted to explore the pharmacokinetic (PK) interactions between OM3 4 g and atorvastatin (ATV) 40 mg.

Methods: The plasma concentrations of ATV, docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) were determined with LC-MS/MS. Parameters of DHA and EPA were analyzed after baseline correction. Primary endpoints were geometric mean ratios (GMRs) of the area under the concentration-time curve during the dosing interval at steady state (AUCτ,ss) and the maximum plasma concentration at steady state (Cmax,ss) of ATV, DHA, and EPA. All data were analyzed before September 15, 2022.

Results: The plasma concentrations of ATV, docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA) were determined with LC-MS/MS. Parameters of DHA and EPA were analyzed after baseline correction. Primary endpoints were geometric mean ratios (GMRs) of the area under the concentration-time curve during the dosing interval at steady state (AUCτ,ss) and the maximum plasma concentration at steady state (Cmax,ss) of ATV, DHA, and EPA.

Conclusion: As the efficacy of OM3 4 g and ATV 40 mg co-administration was established in a phase 3 study [2], their fixed dose combination could be an alternative for mixed hyperlipidemia patients.

1. Eussen SR, Geleijnse JM, Giltay EJ, Rompelberg CJ, Klungel OH, Kromhout D. Effects of n-3 fatty acids on major cardiovascular events in statin users and non-users with a history of myocardial infarction. Eur Heart J. 2012;33(13):1582-1588. doi:10.1093/eurheartj/ehr499
2. Woo JS, Hong SJ, Cha DH, et al. Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 Fatty Acids 4 g Fixed-dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-week, Multicenter, Randomized, Double-blind Phase III Study. Clin Ther. 2021;43(8):1419-1430. doi:10.1016/j.clinthera.2021.07.001