Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease
Open accessAbstract
BACKGROUND: Both lipid-modifying therapy and antioxidant vitamins are thought to have benefit in patients with coronary disease. We studied simvastatin-niacin and antioxidant-vitamin therapy, alone and together, for cardiovascular protection in patients with coronary disease and low plasma levels of HDL. METHODS: In a three-year, double-blind trial, 160 patients with coronary disease, low HDL cholesterol levels and normal LDL cholesterol levels were randomly assigned to receive one of four regimens: simvastatin plus niacin, vitamins, simvastatin-niacin plus antioxidants; or placebos. The end points were arteriographic evidence of a change in coronary stenosis and the occurrence of a first cardiovascular event (death, myocardial infarction, stroke, or revascularization). RESULTS: The mean levels of LDL and HDL cholesterol were unaltered in the antioxidant group and the placebo group; these levels changed substantially (by -42 percent and +26 percent, respectively) in the simvastatin-niacin group. The protective increase in HDL2 with simvastatin plus niacin was attenuated by concurrent therapy with antioxidants. The average stenosis progressed by 3.9 percent with placebos, 1.8 percent with antioxidants (P=0.16 for the comparison with the placebo group), and 0.7 percent with simvastatin-niacin plus antioxidants (P=0.004) and regressed by 0.4 percent with simvastatin-niacin alone (P<0.001). The frequency of the clinical end point was 24 percent with placebos; 3 percent with simvastatin-niacin alone; 21 percent in the antioxidant-therapy group; and 14 percent in the simvastatin-niacin-plus-antioxidants group. CONCLUSIONS: Simvastatin plus niacin provides marked clinical and angiographically measurable benefits in patients with coronary disease and low HDL levels. The use of antioxidant vitamins in this setting must be questioned.
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Clinical trials using niacin, alone or in combination with other lipid medications, have shown benefits in decreasing cardiovascular event rates and atherosclerosis.
“Clinical trials using niacin, alone or in combination with other lipid medications, have shown benefits in decreasing cardiovascular event rates and atherosclerosis (173-176).”
From Evaluation and Treatment of Hypertriglyceridemia: An Endocrine Society Clinical Practice Guideline (2012) · cites this paper as [176]
HATS showed small regression of angiographic coronary plaques with combined nicotinic acid and statin versus progression on placebo, and a 90% lower cardiovascular event risk, though in very few patients.
“The HATS study showed not only a small regression of angiographically measured coronary plaques due to combined nicotinic acid and statin treatment as compared with progression observed on placebo, but also 90% lower risk of CV events, although in a very small number of patients.145”
From ESC/EAS Guidelines for the management of dyslipidaemias (2011) · cites this paper as [145]
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- Authors
- Brown, B. G., Zhao, X.-Q., Chait, A., Fisher, L. D., Cheung, M. C., Morse, J. S., Dowdy, A. A., Marino, E. K., Bolson, E. L., Alaupovic, P., Frohlich, J., Serafini, L., Huss-Frechette, E., Wang, S., DeAngelis, D., Dodek, A., & Albers, J. J.
- Affiliations
- University of Washington (US)
- Oklahoma Medical Research Foundation (US)
- University of British Columbia (CA)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2001-11-29
- Volume
- 345
- Issue
- 22
- Pages
- 1583-1592
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2046991199
- Cited by
- 1,979
- References
- 39
- Citations by year
- 2026: 9 · 2025: 12 · 2024: 25 · 2023: 17 · 2022: 19 · 2021: 16 · 2020: 28 · 2019: 30 · 2018: 26 · 2017: 34 · 2016: 44 · 2015: 56 · 2014: 63 · 2013: 112 · 2012: 98
- FWCI
- 122.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Upsher-Smith
- U.S. Public Health Service (MO1 00037)
- Merck Sharp and Dohme
- National Heart, Lung, and Blood Institute (R01HL049546, R01 HL49546)
- National Institute of Diabetes and Digestive and Kidney Diseases (DK-35816, DK-17047, P30DK035816, P30DK017047)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Biochemistry › Antioxidant Activity and Oxidative Stress
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Keywords
- simvastatin, nicotinic acid, antioxidant vitamins, coronary artery disease, low HDL cholesterol, HDL2, coronary stenosis progression, cardiovascular events, lipid therapy, combination therapy, LDL cholesterol
- MeSH terms
- Hypolipidemic Agents, Antioxidants, Apolipoproteins, Ascorbic Acid, Cardiovascular Diseases, Coronary Disease, Double-Blind Method, Drug Interactions, Drug Therapy, Combination, Female, Humans, Lipids, Cholesterol, HDL, Cholesterol, LDL, Male, Middle Aged, Niacin, Selenium, Vitamin E, Coronary Angiography, Hydroxymethylglutaryl-CoA Reductase Inhibitors, beta Carotene, Simvastatin, Coronary Stenosis, alpha-Tocopherol
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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