Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Title
- Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- Author
- 이창범
- Keywords
- Atorvastatin; Fatty acids; omega-3; Hypertriglyceridemia
- Issue Date
- 2020-02
- Publisher
- KOREAN DIABETES ASSOC
- Citation
- DIABETES & METABOLISM JOURNAL, v. 44, no. 1, Page. 78-90
- 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 effi-
cacy 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.
- URI
- https://e-dmj.org/DOIx.php?id=10.4093/dmj.2018.0265https://repository.hanyang.ac.kr/handle/20.500.11754/151478
- ISSN
- 2233-6079; 2233-6087
- DOI
- 10.4093/dmj.2018.0265
- Appears in Collections:
- COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
- Files in This Item:
- Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia A Randomized, Double-Blind, Placebo-C...Download
- Export
- RIS (EndNote)
- XLS (Excel)
- XML