Effects of prescription niacin and omega-3 fatty acids on lipids and vascular function in metabolic syndrome: a randomized controlled trial
Open accessAbstract
The metabolic syndrome includes both dyslipidemia and impaired vascular function. Because extended-release niacin (ERN) and prescription omega-3 acid ethyl-esters (P-OM3) independently improve these characteristics, we tested their effects in combination. Sixty metabolic syndrome subjects were randomized to 16 weeks of treatment on dual placebo, P-OM3 (4 g/day), ERN (2 g/day), or combination in a double-blind trial. Lipoprotein subfractions and vascular endpoints were measured and tested using ANCOVA. ERN increased HDL cholesterol by 5.4 mg/dl from baseline (P = 0.04), decreased triglycerides (TG) by 39 mg/dl (-21%, P = 0.003), and decreased the augmentation index, which is a measure of vascular stiffness, by 3.5 units (P = 0.04). P-OM3 reduced TG by 26 mg/dl (-13%, P = 0.04). Combination treatment increased HDL cholesterol by 7.8 mg/dl (P = 002) and decreased TG by 72 mg/dl (-34%) but there was no improvement in vascular stiffness. Detailed analysis of lipoprotein subfractions revealed increased large, bouyant HDL(2) (3.3 mg/dl; P = 0.002) and decreased VLDL(1+2) (-32%; P < 0.0001), among subjects treated with combination therapy, that were not present with either therapy alone. ERN and P-OM3 alone improved characteristics of metabolic syndrome; however, whereas subjects on combination therapy did not have improved vascular stiffness, TG and HDL levels improved as did certain lipoprotein subfractions.
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In a Japanese trial of about 600 patients with hypertriglyceridemia, 4 g/d O3AEE reduced triglycerides by about 22%, while 2 g/d O3AEE and 2 g/d IPE each reduced triglycerides by about 11% after 12 weeks.
“Triglyceride reductions from baseline were ≈22% in the 4 g/d O3AEE group and ≈11% for both the O3AEE and IPE 2 g/d groups after 12 weeks”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [52]
The Methods (Study design; page unavailable) describe a 16-week trial with 60 participants assigned to placebo, 4 g/day prescription omega-3, 2 g/day niacin, or their combination—not the claimed 12-week, approximately 600-patient comparison of O3AEE and IPE doses. The Results (Effects on lipid and lipoprotein levels; page unavailable) report a 13% triglyceride reduction with omega-3 alone, rather than approximately 22%. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredIn that trial, non-HDL-C decreased by 4% to 6% in all three groups at 12 and 52 weeks.
“Non-HDL-C decreased by 4% to 6% in all 3 groups at 12 and 52 weeks”
From Omega-3 Fatty Acids for the Management of Hypertriglyceridemia: A Science Advisory From the American Heart Association (2019) · cites this paper as [52]
The Methods (Study design; page unavailable) describe four groups treated for 16 weeks, not three groups assessed at 12 and 52 weeks. Results (Table 3; page unavailable) report non-HDL-C decreases in all four groups, but as changes in mg/dL (−5.9, −23, −11, and −7.3), not a 4%–6% decrease in three groups at those time points. (LLM, conf=0.90)
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- Authors
- Shearer, G. C., Pottala, J. V., Hansen, S. N., Brandenburg, V., & Harris, W. S.
- Affiliations
- University of South Dakota (US)
- Corresponding author
- Shearer, Gregory C.
- Venue
- Journal of Lipid Research
- Publisher
- Elsevier BV
- Published
- 2012-11
- Volume
- 53
- Issue
- 11
- Pages
- 2429-2435
- ISSN
- 0022-2275 (ISSN-L)
- PMC
- PMC3466011
- OpenAlex
- W2021910980
- Cited by
- 42
- References
- 32
- Citations by year
- 2024: 3 · 2023: 5 · 2022: 1 · 2021: 3 · 2020: 2 · 2019: 2 · 2018: 2 · 2017: 5 · 2016: 4 · 2015: 3 · 2014: 4 · 2013: 8
- FWCI
- 4.48
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Lipid Research (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- GlaxoSmithKline
- National Institutes of Health (5r01dk061486-06, 5 R01DK061486)
- National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK061486, 5 R01 DK061486)
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- metabolic syndrome, nicotinic acid, omega-3 fatty acids, extended-release niacin, combination therapy, dyslipidemia, vascular function, vascular stiffness, augmentation index, HDL cholesterol, HDL2, triglycerides, lipoprotein subfractions, VLDL
- MeSH terms
- Adult, Docosahexaenoic Acids, Female, Humans, Lipids, Lipoproteins, Lipoproteins, HDL, Lipoproteins, VLDL, Male, Middle Aged, Niacin, Eicosapentaenoic Acid, Fatty Acids, Omega-3, Metabolic Syndrome
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