Abstract
Background:
This study was designed to evaluate the effects of omega-3 fatty acids supplements and simvastatin on lipoproteins and heart rate variability (HRV), a surrogate parameter of cardiac autonomic function, in patients with mixed dyslipidemia.
Methods:
This study was a prospective, randomized, open-label study. Among the 171 patients screened, 62 who met the inclusion criteria after 6 weeks on a strict diet therapy were randomized into two treatment groups. The inclusion criteria were mixed dyslipidemia with a high triglyceride level (200–499 mg per 100 ml) and a total cholesterol level >200 mg per 100 ml. After a run-in period of 6 weeks, the patients were randomized into two groups and given a combination treatment with 4 g of omega-3 fatty acids (four 1 g Omacor (eicosapentaenoic acid, 465 mg; docosahexaenoic acid, 375 mg; other omega-3 fatty acids, 60 mg; others 100 mg, Gun-il Pharmacy, Seoul, Korea)) and 20 mg of simvastatin daily or a monotherapy of 20 mg simvastatin for 6 weeks. In the combination therapy group, seven patients dropped out, and in the simvastatin alone therapy group, five patients dropped out during the study period.
Results:
After 6 weeks of drug treatment, triglyceride levels decreased by 41.0% in the combination treatment group and 13.9% in the simvastatin monotherapy group (from 309.2±95 mg per 100 ml to 177.7±66 versus 294.6±78 mg per 100 ml to 238.3±84 mg per 100 ml, respectively, P=0.0007). No significant changes in the HRV parameters were observed in either group.
Conclusion:
The combination of omega-3 fatty acids plus simvastatin, which achieved a significantly greater reduction of triglycerides without adverse reactions, should be considered as an optimal treatment option for patients with mixed dyslipidemia.
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Acknowledgements
This work was supported by the Innovative Research Institute for Cell Therapy (IRICT) and the Clinical Research Center for Ischemic Heart Disease (0412-CR02-0704-0001). Dr Hyo-Soo Kim is a professor of Molecular Medicine & Biopharmaceutical Sciences, Seoul National University sponsored by World Class University Program from the Ministry of Education, Science, and Technology, Korea.
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Kim, SH., Kim, MK., Lee, HY. et al. Prospective randomized comparison between omega-3 fatty acid supplements plus simvastatin versus simvastatin alone in Korean patients with mixed dyslipidemia: lipoprotein profiles and heart rate variability. Eur J Clin Nutr 65, 110–116 (2011). https://doi.org/10.1038/ejcn.2010.195
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DOI: https://doi.org/10.1038/ejcn.2010.195
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