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
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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Nutraceuticals, either alone or in combination, when administered with statins seem to confer additional benefit on plasma lipid profiles, allowing statin doses to be reduced without diminishing total cholesterol and LDL-C reduction, and significantly limiting adverse effects.
“Nutraceuticals, either alone or in combination, when administered with statins seem to confer additional benefit on plasma lipid profiles (Table 5), allowing the statin doses to be reduced (in case of statin intolerance) without diminishing the results in terms of total cholesterol (TC) and LDL-C reduction (109-121) and significantly limiting adverse effects (122).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [110]
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- Authors
- Kim, S.-H., Kim, M.-K., Lee, H.-Y., Kang, H.-J., Kim, Y.-J., & Kim, H.-S.
- Affiliations
- Seoul National University (KR)
- Corresponding author
- Kim, Hyo-Soo
- Venue
- European Journal of Clinical Nutrition
- Published
- 2010-09-29
- Volume
- 65
- Issue
- 1
- Pages
- 110-116
- ISSN
- 0954-3007 (ISSN-L)
- 1476-5640
- OpenAlex
- W2026613797
- Cited by
- 21
- References
- 25
- Citations by year
- 2024: 1 · 2023: 1 · 2019: 2 · 2018: 1 · 2017: 4 · 2016: 3 · 2015: 1 · 2013: 4 · 2012: 1
- FWCI
- 2.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Clinical Nutrition (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Seoul
- Seoul National University Hospital
- NIH Clinical Center
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- omega-3 fatty acids, simvastatin, mixed dyslipidemia, triglyceride lowering, lipoprotein profile, heart rate variability, cardiac autonomic function, eicosapentaenoic acid, docosahexaenoic acid, combination therapy, hypertriglyceridemia, hypercholesterolemia
- MeSH terms
- Adult, Aged, Hypolipidemic Agents, Cholesterol, Docosahexaenoic Acids, Drug Combinations, Drug Therapy, Combination, Female, Heart Rate, Humans, Lipoproteins, Male, Middle Aged, Prospective Studies, Triglycerides, Eicosapentaenoic Acid, Fatty Acids, Omega-3, Dietary Supplements, Simvastatin, Asian People, Dyslipidemias, Republic of Korea
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