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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

Authors
 Ji Eun Jun  ;  In Kyung Jeong  ;  Jae Myung Yu  ;  Sung Rae Kim  ;  In Kye Lee  ;  Kyung Ah Han  ;  Sung Hee Choi  ;  Soo Kyung Kim  ;  Hyeong Kyu Park  ;  Ji Oh Mok  ;  Yong Ho Lee  ;  Hyuk Sang Kwon  ;  So Hun Kim  ;  Ho Cheol Kang  ;  Sang Ah Lee  ;  Chang Beom Lee  ;  Kyung Mook Choi  ;  Sung Ho Her  ;  Won Yong Shin  ;  Mi Seung Shin  ;  Hyo Suk Ahn  ;  Seung Ho Kang  ;  Jin Man Cho  ;  Sang Ho Jo  ;  Tae Joon Cha  ;  Seok Yeon Kim  ;  Kyung Heon Won  ;  Dong Bin Kim  ;  Jae Hyuk Lee  ;  Moon Kyu Lee 
Citation
 DIABETES & METABOLISM JOURNAL, Vol.44(1) : 78-90, 2020-02 
Journal Title
 DIABETES & METABOLISM JOURNAL 
ISSN
 2233-6079 
Issue Date
2020-02
Keywords
Atorvastatin ; Fatty acids, omega-3 ; Hypertriglyceridemia
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 (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.
Files in This Item:
T202001578.pdf Download
DOI
10.4093/dmj.2018.0265
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Yong Ho(이용호) ORCID logo https://orcid.org/0000-0002-6219-4942
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/176190
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