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Omega-3 Fatty Acids in Statin-Treated Patients With Hypertriglyceridemia
Study Questions:
What is the efficacy and safety of adding omega-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment?
Methods:
The ROMANTIC study investigators conducted 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 omega-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. The efficacy endpoints were the percentage change of lipid and lipoprotein levels, including triglycerides (TGs), non–high-density lipoprotein cholesterol (non–HDL-C), total cholesterol, low-density lipoprotein cholesterol (LDL-C), HDL-C, very LDL-C (VLDL-C), and apolipoprotein A1 and B (Apo A1 and Apo B) after 8 weeks from baseline. To identify the clinical factors associated with the greater effect of omega-3 fatty acids in lowering TG and non–HDL-C levels, linear regression analyses were performed and the prediction model was obtained.
Results:
A total of 201 patients were analyzed (mean [standard deviation] age, 58.1 [10.7] years; 62.7% male). After 8 weeks of treatment, the percentage change from baseline in 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 omega-3 fatty acids was greater when baseline TG or non–HDL-C levels were high and body mass index (BMI) was low. The incidence of adverse events was not significantly different between the two groups.
Conclusions:
The authors concluded that in patients with residual hypertriglyceridemia despite statin treatment, a combination of omega-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non–HDL-C than rosuvastatin alone.
Perspective:
This study reports that a combination of omega-3 fatty acids and rosuvastatin in patients with residual hypertriglyceridemia achieved a greater reduction in TG, non–HDL-C, and other lipid and lipoprotein levels than rosuvastatin alone did. Furthermore, the higher the baseline TG and non-HDL levels and the lower the BMI, the better the effect of omega-3 fatty acids, and the effect of lowering non–HDL-C levels was also more noticeable in patients with diabetes mellitus. Finally, there was no apparent adverse event to adding 4 g/d of omega-3 fatty acids to rosuvastatin. Additional studies are needed to assess whether the reduction in TGs with omega-3 fatty acids actually leads to better outcomes and prevention of cardiovascular events before recommending their use on top of statins.
Keywords: Apolipoprotein A-I, Apolipoproteins B, Body Mass Index, Cholesterol, HDL, Cholesterol, LDL, Cholesterol, VLDL, Diabetes Mellitus, Docosahexaenoic Acids, Dyslipidemias, Eicosapentaenoic Acid, Fatty Acids, Omega-3, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hypertriglyceridemia, Lipoproteins, Metabolic Syndrome, Primary Prevention, Triglycerides
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