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Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial

Kim, CH | Han, KA | Yu, J | Lee, SH | Jeon, HK | Kim, SH | Kim, SY | Han, KH | Won, K | Kim, DB | Lee, KJ | Min, K | Byun, DW | Lim, SW | Ahn, CW | Kim, S | Hong, YJ | Sung, J | Hur, SH | Hong, SJ | Lim, HS  | Park, IB | Kim, IJ | Lee, H | Kim, HS
Clinical therapeutics, 40(1). : 83-94, 2018
Journal Title
Clinical therapeutics
PURPOSE: The purpose of this study was to examine the efficacy and safety of adding omega-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment.
METHODS: This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus omega-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks.
FINDINGS: A total of 201 patients were analyzed (mean [SD] age, 58.1 [10.7] years: 62.7% male). After 8 weeks of treatment, the percentage change from baseline in triglycerides (TGs) and non-HDL-C was significantly greater in the ROSUMEGA group than in the rosuvastatin group (TGs: -26.3% vs -11.4%, P < 0.001: non-HDL-C: -10.7% vs -2.2%, P = 0.001). In the linear regression analysis, the lipid-lowering effect of omega-3 fatty acids was greater when baseline TG or non-HDL-C levels were high and body mass index was low. The incidence of adverse events was not significantly different between the 2 groups.
IMPLICATIONS: In patients with residual hypertriglyceridemia despite statin treatment, a combination of omega-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non-HDL-C than rosuvastatin alone. Further study is needed to determine whether the advantages of this lipid profile of omega-3 fatty acids actually leads to the prevention of cardiovascular event.
ClinicalTrials.gov identifier: NCT03026933.

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Journal Papers > School of Medicine / Graduate School of Medicine > Cardiology
Ajou Authors
임, 홍석
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