Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- 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.
- All Author(s)
- J. E. Jun
; I. K. Jeong
; J. M. Yu
; S. R. Kim
; I. K. Lee
; K. A. Han
; S. H. Choi
; S. K. Kim
; H. K. Park
; J. O. Mok
; Y. H. Lee
; H. S. Kwon
; S. H. Kim
; H. C. Kang
; S. A. Lee
; C. B. Lee
; K. M. Choi
; S. H. Her
; W. Y. Shin
; M. S. Shin
; H. S. Ahn
; S. H. Kang
; J. M. Cho
; S. H. Jo
; T. J. Cha
; S. Y. Kim
; K. H. Won
; D. B. Kim
; J. H. Lee
; M. K. Lee
- Issued Date
- 2020
- Type
- Article
- Keyword
- Atorvastatin; Fatty acids, omega-3; Hypertriglyceridemia
- Publisher
- 대한당뇨병학회
- ISSN
- 2233-6079
- Citation Title
- Diabetes & Metabolism Journal
- Citation Volume
- 44
- Citation Number
- 1
- Citation Start Page
- 78
- Citation End Page
- 90
- Language(ISO)
- eng
- DOI
- 10.4093/dmj.2018.0265
- URI
- http://schca-ir.schmc.ac.kr/handle/2022.oak/1882
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