Document Detail


Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease.
MedLine Citation:
PMID:  11757504     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
B G Brown; X Q Zhao; A Chait; L D Fisher; M C Cheung; J S Morse; A A Dowdy; E K Marino; E L Bolson; P Alaupovic; J Frohlich; J J Albers
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The New England journal of medicine     Volume:  345     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2001 Nov 
Date Detail:
Created Date:  2001-11-19     Completed Date:  2001-12-28     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1583-92     Citation Subset:  AIM; IM    
Affiliation:
Department of Medicine, University of Washington School of Medicine, Seattle 98195, USA.
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MeSH Terms
Descriptor/Qualifier:
Antilipemic Agents / adverse effects,  therapeutic use*
Antioxidants / therapeutic use*
Apolipoproteins / blood
Ascorbic Acid / blood,  therapeutic use
Cardiovascular Diseases / mortality,  prevention & control
Cholesterol, HDL / blood*
Cholesterol, LDL / blood
Coronary Angiography
Coronary Disease / drug therapy,  mortality,  prevention & control*
Coronary Stenosis / drug therapy*
Double-Blind Method
Drug Interactions
Drug Therapy, Combination
Female
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
Lipids / blood
Male
Middle Aged
Niacin / adverse effects,  therapeutic use*
Selenium / therapeutic use
Simvastatin / therapeutic use*
Vitamin E / blood
alpha-Tocopherol / therapeutic use
beta Carotene / blood,  therapeutic use
Grant Support
ID/Acronym/Agency:
DK 17047/DK/NIDDK NIH HHS; DK 35816/DK/NIDDK NIH HHS; MO1 00037//PHS HHS; R01 HL49546/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Antilipemic Agents; 0/Antioxidants; 0/Apolipoproteins; 0/Cholesterol, HDL; 0/Cholesterol, LDL; 0/Hydroxymethylglutaryl-CoA Reductase Inhibitors; 0/Lipids; 1406-18-4/Vitamin E; 50-81-7/Ascorbic Acid; 59-02-9/alpha-Tocopherol; 59-67-6/Niacin; 7235-40-7/beta Carotene; 7782-49-2/Selenium; 79902-63-9/Simvastatin
Comments/Corrections
Comment In:
N Engl J Med. 2001 Nov 29;345(22):1636-7   [PMID:  11757512 ]
Rev Cardiovasc Med. 2002 Fall;3(4):205-6   [PMID:  12556756 ]
N Engl J Med. 2002 Apr 4;346(14):1092-3   [PMID:  11932481 ]
Summary for patients in:
Curr Cardiol Rep. 2002 Nov;4(6):486   [PMID:  12379170 ]

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