Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial

Chee Hae Kim, Kyung Ah Han, Jaemyung Yu, Sang Hak Lee, Hui Kyung Jeon, Sang Hyun Kim, Seok Yeon Kim, Ki Hoon Han, Kyungheon Won, Dong Bin Kim, Kwang Jae Lee, Kyungwan Min, Dong Won Byun, Sang Wook Lim, Chul Woo Ahn, Seong Hwan Kim, Young Joon Hong, Jidong Sung, Seung Ho Hur, Soon Jun HongHong Seok Lim, Ie Byung Park, In Joo Kim, Hyoungwoo Lee, Hyo Soo Kim

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5 Citations (Scopus)

Abstract

Purpose The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment. Methods This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks. Findings A total of 201 patients were analyzed (mean [SD] age, 58.1 [10.7] years; 62.7% male). After 8 weeks of treatment, the percentage change from baseline in triglycerides (TGs) and non–HDL-C was significantly greater in the ROSUMEGA group than in the rosuvastatin group (TGs: −26.3% vs −11.4%, P < 0.001; non–HDL-C: −10.7% vs −2.2%, P = 0.001). In the linear regression analysis, the lipid-lowering effect of ω-3 fatty acids was greater when baseline TG or non−HDL-C levels were high and body mass index was low. The incidence of adverse events was not significantly different between the 2 groups. Implications In patients with residual hypertriglyceridemia despite statin treatment, a combination of ω-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non−HDL-C than rosuvastatin alone. Further study is needed to determine whether the advantages of this lipid profile of ω-3 fatty acids actually leads to the prevention of cardiovascular event. ClinicalTrials.gov identifier: NCT03026933.

Original languageEnglish
Pages (from-to)83-94
Number of pages12
JournalClinical Therapeutics
Volume40
Issue number1
DOIs
Publication statusPublished - 2018 Jan 1

Keywords

  • combination
  • hypertriglyceridemia
  • non–HDL-C
  • rosuvastatin
  • triglycerides
  • ω-3 fatty acids

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

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    Kim, C. H., Han, K. A., Yu, J., Lee, S. H., Jeon, H. K., Kim, S. H., Kim, S. Y., Han, K. H., Won, K., Kim, D. B., Lee, K. J., Min, K., Byun, D. W., Lim, S. W., Ahn, C. W., Kim, S. H., Hong, Y. J., Sung, J., Hur, S. H., ... Kim, H. S. (2018). Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia: ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial. Clinical Therapeutics, 40(1), 83-94. https://doi.org/10.1016/j.clinthera.2017.11.007