Efficacy and safety of omega-3 fatty acids in patients treated with statins for residual hypertriglyceridemia: A randomized, double-blind, placebo-controlled clinical trial

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 ShinHyo 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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)78-90
Number of pages13
JournalDiabetes and Metabolism Journal
Volume44
Issue number1
DOIs
Publication statusPublished - 2020 Feb 1

Keywords

  • Atorvastatin
  • Fatty acids
  • Hypertriglyceridemia
  • Omega-3

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism

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    Jun, J. E., Jeong, I. K., Yu, J. M., Kim, S. R., Lee, I. K., Han, K. A., Choi, S. H., Kim, S. K., Park, H. K., Mok, J. O., Lee, Y. H., Kwon, H. S., Kim, S. H., Kang, H. C., Lee, S. A., Lee, C. B., Choi, K. M., Her, S. H., Shin, W. Y., ... Lee, M. K. (2020). Efficacy and safety of omega-3 fatty acids in patients treated with statins for residual hypertriglyceridemia: A randomized, double-blind, placebo-controlled clinical trial. Diabetes and Metabolism Journal, 44(1), 78-90. https://doi.org/10.4093/dmj.2018.0265