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

Research output: Contribution to journalArticle

4 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

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Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypertriglyceridemia
Omega-3 Fatty Acids
Placebos
Safety
Fatty Acids
Triglycerides
Lipids
Omacor
Rosuvastatin Calcium
Therapeutics
Linear Models
Body Mass Index
Regression Analysis
Incidence

Keywords

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

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

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

In: Clinical Therapeutics, Vol. 40, No. 1, 01.01.2018, p. 83-94.

Research output: Contribution to journalArticle

Kim, CH, Han, KA, Yu, J, Lee, SH, Jeon, HK, Kim, SH, Kim, SY, Han, KH, Won, K, Kim, DB, Lee, KJ, Min, K, Byun, DW, Lim, SW, Ahn, CW, Kim, SH, Hong, YJ, Sung, J, Hur, SH, Hong, SJ, Lim, HS, Park, IB, Kim, IJ, Lee, H & Kim, HS 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, vol. 40, no. 1, pp. 83-94. https://doi.org/10.1016/j.clinthera.2017.11.007
Kim, Chee Hae ; Han, Kyung Ah ; Yu, Jaemyung ; Lee, Sang Hak ; Jeon, Hui Kyung ; Kim, Sang Hyun ; Kim, Seok Yeon ; Han, Ki Hoon ; Won, Kyungheon ; Kim, Dong Bin ; Lee, Kwang Jae ; Min, Kyungwan ; Byun, Dong Won ; Lim, Sang Wook ; Ahn, Chul Woo ; Kim, Seong Hwan ; Hong, Young Joon ; Sung, Jidong ; Hur, Seung Ho ; Hong, Soon Jun ; Lim, Hong Seok ; Park, Ie Byung ; Kim, In Joo ; Lee, Hyoungwoo ; Kim, Hyo Soo. / 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. In: Clinical Therapeutics. 2018 ; Vol. 40, No. 1. pp. 83-94.
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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.",
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author = "Kim, {Chee Hae} and Han, {Kyung Ah} and Jaemyung Yu and Lee, {Sang Hak} and Jeon, {Hui Kyung} and Kim, {Sang Hyun} and Kim, {Seok Yeon} and Han, {Ki Hoon} and Kyungheon Won and Kim, {Dong Bin} and Lee, {Kwang Jae} and Kyungwan Min and Byun, {Dong Won} and Lim, {Sang Wook} and Ahn, {Chul Woo} and Kim, {Seong Hwan} and Hong, {Young Joon} and Jidong Sung and Hur, {Seung Ho} and Hong, {Soon Jun} and Lim, {Hong Seok} and Park, {Ie Byung} and Kim, {In Joo} and Hyoungwoo Lee and Kim, {Hyo Soo}",
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T1 - Efficacy and Safety of Adding Omega-3 Fatty Acids in Statin-treated Patients with Residual Hypertriglyceridemia

T2 - ROMANTIC (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia), a Randomized, Double-blind, and Placebo-controlled Trial

AU - Kim, Chee Hae

AU - Han, Kyung Ah

AU - Yu, Jaemyung

AU - Lee, Sang Hak

AU - Jeon, Hui Kyung

AU - Kim, Sang Hyun

AU - Kim, Seok Yeon

AU - Han, Ki Hoon

AU - Won, Kyungheon

AU - Kim, Dong Bin

AU - Lee, Kwang Jae

AU - Min, Kyungwan

AU - Byun, Dong Won

AU - Lim, Sang Wook

AU - Ahn, Chul Woo

AU - Kim, Seong Hwan

AU - Hong, Young Joon

AU - Sung, Jidong

AU - Hur, Seung Ho

AU - Hong, Soon Jun

AU - Lim, Hong Seok

AU - Park, Ie Byung

AU - Kim, In Joo

AU - Lee, Hyoungwoo

AU - Kim, Hyo Soo

PY - 2018/1/1

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N2 - 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.

AB - 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.

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KW - non–HDL-C

KW - rosuvastatin

KW - triglycerides

KW - ω-3 fatty acids

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