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KMID : 1200020200440010078
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Diabetes & Metabolism Journal
2020 Volume.44 No. 1 p.78 ~ p.90
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Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
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Jun Ji-Eun
Jeong In-Kyung
Yu Jae-Myung
Kim Sung-Rae
Lee In-Kye
Han Kyung-Ah
Choi Sung-Hee
Kim Soo-Kyung
Park Hyeong-Kyu
Mok Ji-Oh
Lee Yong-Ho
Kwon Hyuk-Sang
Kim So-Hun
Kang Ho-Cheol
Lee Sang-Ah
Lee Chang-Beom
Choi Kyung-Mook
Her Sung-Ho
Shin Won-Yong
Shin Mi-Seung
Ahn Hyo-Suk
Kang Seung-Ho
Cho Jin-Man
Jo Sang-Ho
Cha Tae-Joon
Kim Seok-Yeon
Kim Dong-Bin
Lee Jae-Hyuk
Lee Moon-Kyu
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Abstract
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Background: Cardiovascular risk remains increased despite optimal low density lipoprotein cholesterol (LDL-C) level induced by intensive statin therapy. Therefore, recent guidelines recommend non-high density lipoprotein cholesterol (non-HDL-C) as a secondary target for preventing cardiovascular events. The aim of this study was to assess the efficacy and tolerability of omega-3 fatty acids (OM3-FAs) in combination with atorvastatin compared to atorvastatin alone in patients with mixed dyslipidemia.
Methods: This randomized, double-blind, placebo-controlled, parallel-group, and phase III multicenter study included adults with fasting triglyceride (TG) levels ≥200 and <500 mg/dL and LDL-C levels <110 mg/dL. Eligible subjects were randomized to ATOMEGA (OM3-FAs 4,000 mg plus atorvastatin calcium 20 mg) or atorvastatin 20 mg plus placebo groups. The primary efficacy endpoints were the percent changes in TG and non-HDL-C levels from baseline at the end of treatment.
Results: After 8 weeks of treatment, the percent changes from baseline in TG (?29.8% vs. 3.6%, P<0.001) and non-HDL-C (?10.1% vs. 4.9%, P<0.001) levels were significantly greater in the ATOMEGA group (n=97) than in the atorvastatin group (n=103). Moreover, the proportion of total subjects reaching TG target of <200 mg/dL in the ATOMEGA group was significantly higher than that in the atorvastatin group (62.9% vs. 22.3%, P<0.001). The incidence of adverse events did not differ between the two groups.
Conclusion: The addition of OM3-FAs to atorvastatin improved TG and non-HDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.
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KEYWORD
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Atorvastatin, Fatty acids, omega-3, Hypertriglyceridemia
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