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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.

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Author(s)
Chee Hae KimKyung Ah HanJaemyung YuSang Hak LeeHui Kyung JeonSang Hyun KimSeok Yeon KimKi Hoon HanKyungheon WonDong-Bin KimKwang-Jae LeeKyungwan MinDong Won ByunSang-Wook LimChul Woo AhnSeongHwan KimYoung Joon HongJidong SungSeung-Ho HurSoon Jun HongHong-Seok LimIe Byung ParkIn Joo KimHyoungwoo LeeHyo-Soo Kim
Keimyung Author(s)
Hur, Seung Ho
Department
Dept. of Internal Medicine (내과학)
Journal Title
Clinical Therapeutics
Issued Date
2018
Volume
40
Issue
1
Keyword
hypertriglyceridemiacombinationnon–HDL-Crosuvastatintriglyceridesω-3 fatty acids
Abstract
PURPOSE:

The purpose of this study was to examine the efficacy and safety of adding ω-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 ω-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 ω-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 ω-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 ω-3 fatty acids actually leads to the prevention of cardiovascular event. ClinicalTrials.
Keimyung Author(s)(Kor)
허승호
Publisher
School of Medicine (의과대학)
Citation
Chee Hae Kim et al. (2018). 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. Clinical Therapeutics, 40(1), 83–94. doi: 10.1016/j.clinthera.2017.11.007
Type
Article
ISSN
0149-2918
DOI
10.1016/j.clinthera.2017.11.007
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41223
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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