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:
Ji Eun JUN
1
;
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
Author Information
- Publication Type:Original Article
- From:Diabetes & Metabolism Journal 2020;44(1):78-90
- CountryRepublic of Korea
- Language:English
-
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.
