Efficacy and Safety of Omega-3 Fatty Acids in Patients Treated with Statins for Residual Hypertriglyceridemia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

• Published in: Diabetes & metabolism journal Vol. 44; no. 1; pp. 78 - 90
• Main 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
• Format: Journal Article
• Language: English
• Published: Korea (South) Korean Diabetes Association / Daehan Dangnyobyeong Hakoe 01.02.2020; Korean Diabetes Association; 대한당뇨병학회
• Subjects: Aged; atorvastatin; Atorvastatin - administration & dosage; Cardiovascular disease; Cholesterol; Cholesterol, HDL - blood; Cholesterol, LDL - blood; Clinical trials; Coronary vessels; Double-Blind Method; fatty acids, omega-3; Fatty Acids, Omega-3 - administration & dosage; Female; High density lipoprotein; HIV; Human immunodeficiency virus; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hypertension; hypertriglyceridemia; Hypertriglyceridemia - drug therapy; Laboratories; Linear Models; Lipids; Lipoproteins; Male; Metabolic disorders; Middle Aged; Omega-3 fatty acids; Original; Risk factors; Statins; Triglycerides - blood; 내과학; Atorvastatin; Fatty acids, omega-3; Hypertriglyceridemia
• ISSN: 2233-6079; 2233-6087; 2233-6087
• DOI: 10.4093/dmj.2018.0265

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. 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. After 8 weeks of treatment, the percent changes from baseline in TG (-29.8% vs. 3.6%, <0.001) and non-HDL-C (-10.1% vs. 4.9%, <0.001) levels were significantly greater in the ATOMEGA group ( =97) than in the atorvastatin group ( =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%, <0.001). The incidence of adverse events did not differ between the two groups. 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.