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Clin Ther. 2018 Jan;40(1):83-94. doi: 10.1016/j.clinthera.2017.11.007. Epub 2017 Dec 7.

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.

Author information

1
Department of Internal Medicine, Seoul National University Hospital, Cardiovascular Centre, Seoul, Korea.
2
Diabetes Center, Eulji University, Seoul Eulji hospital, Seoul, Korea.
3
Kangnam Sacred Heart Hospital, Seoul, Korea.
4
Cardiology Division, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, Korea.
5
Department of Internal Medicine, Division of Cardiology, The Catholic University of Korea, Seoul, Korea.
6
Department of Cardiology, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
7
Department of Internal Medicine, Seoul Medical Center, Seoul, Korea.
8
Departments of Cardiology, Ischemic Heart Disease Center, Asan Medical Center Heart Institute, Seoul, Korea.
9
Department of Cardiology, Catholic University of Korea College of Medicine, Seoul, Korea.
10
Department of Endocrinology, Daedong Hospital, Seoul, Korea.
11
Endocrinology and Metabolism, Soonchunhyang University Hospital, Seoul, Korea.
12
Department of Cardiology, Bundang Cha General Hospital, Seoul, Korea.
13
Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea.
14
Division of Cardiology, Department of Medicine, Korea University Ansan Hospital, Seoul, Korea.
15
Heart Center of Chonnam National University Hospital, Chonnam National University, Seoul, Korea.
16
Division of Cardiology, Cardiac and Vascular Center, Samsung Medical Center, Seoul, Korea.
17
Department of Cardiology, Keimyung University Dongsan Hospital, Daegu, Korea.
18
Korea University Medical Center, Korea University, Seoul, Korea.
19
Department of Cardiology, Ajou University School of Medicine, Suwon, Korea.
20
Division of Endocrinology and Metabolism, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
21
Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea.
22
Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
23
Department of Internal Medicine, Seoul National University Hospital, Cardiovascular Centre, Seoul, Korea. Electronic address: usahyosoo@gmail.com.

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.

KEYWORDS:

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

PMID:
29223557
DOI:
10.1016/j.clinthera.2017.11.007
[Indexed for MEDLINE]
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