Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Authors
- 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; Won, Kyung Heon; Kim, Dong-Bin; Lee, Jae Hyuk; Lee, Moon-Kyu
- Issue Date
- Feb-2020
- Publisher
- KOREAN DIABETES ASSOC
- Keywords
- Atorvastatin; Fatty acids; omega-3; Hypertriglyceridemia
- Citation
- DIABETES & METABOLISM JOURNAL, v.44, no.1, pp.78 - 90
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- DIABETES & METABOLISM JOURNAL
- Volume
- 44
- Number
- 1
- Start Page
- 78
- End Page
- 90
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/57864
- DOI
- 10.4093/dmj.2018.0265
- ISSN
- 2233-6079
- Abstract
- 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 (0M3-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-I IDL-C levels to a significant extent compared to atorvastatin alone in subjects with residual hypertriglyceridemia.
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