Document Detail

Secondary prevention with antioxidants of cardiovascular disease in endstage renal disease (SPACE): randomised placebo-controlled trial.
MedLine Citation:
PMID:  11072938     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Excess cardiovascular mortality has been documented in chronic haemodialysis patients. Oxidative stress is greater in haemodialysis patients with prevalent cardiovascular disease than in those without, suggesting a role for oxidative stress in excess cardiovascular disease in haemodialysis. We investigated the effect of high-dose vitamin E supplementation on cardiovascular disease outcomes in haemodialysis patients with pre-existing cardiovascular disease. METHODS: Haemodialysis patients with pre-existing cardiovascular disease (n=196) aged 40-75 years at baseline from six dialysis centres were enrolled and randomised to receive 800 IU/day vitamin E or matching placebo. Patients were followed for a median 519 days. The primary endpoint was a composite variable consisting of: myocardial infarction (fatal and non-fatal), ischaemic stroke, peripheral vascular disease (excluding the arteriovenous fistula), and unstable angina. Secondary outcomes included each of the component outcomes, total mortality, and cardiovascular-disease mortality. FINDINGS: A total of 15 (16%) of the 97 patients assigned to vitamin E and 33 (33%) of the 99 patients assigned to placebo had a primary endpoint (relative risk 0.46 [95% CI 0.27-0.78], p=0.014). Five (5.1%) patients assigned to vitamin E and 17 (17.2%) patients assigned to placebo had myocardial infarction (0.3 [0.11-0.78], p=0.016). No significant differences in other secondary endpoints, cardiovascular disease, or total mortality were detected. INTERPRETATION: In haemodialysis patients with prevalent cardiovascular disease, supplementation with 800 IU/day vitamin E reduces composite cardiovascular disease endpoints and myocardial infarction.
M Boaz; S Smetana; T Weinstein; Z Matas; U Gafter; A Iaina; A Knecht; Y Weissgarten; D Brunner; M Fainaru; M S Green
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  356     ISSN:  0140-6736     ISO Abbreviation:  Lancet     Publication Date:  2000 Oct 
Date Detail:
Created Date:  2000-11-09     Completed Date:  2000-11-30     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  1213-8     Citation Subset:  AIM; IM    
Department of Epidemiology and Preventive Medicine, Sackler Faculty of Medicine, Tel Aviv University, Israel.
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MeSH Terms
Antioxidants / adverse effects,  therapeutic use*
Cardiovascular Diseases / complications,  prevention & control*
Deglutition / drug effects
Double-Blind Method
Follow-Up Studies
Gastrointestinal Diseases / chemically induced
Kidney Failure, Chronic / complications,  therapy*
Middle Aged
Pruritus / chemically induced
Renal Dialysis
Survival Analysis
Treatment Outcome
Vitamin E / adverse effects,  therapeutic use*
Reg. No./Substance:
0/Antioxidants; 1406-18-4/Vitamin E
Comment In:
Lancet. 2001 Feb 24;357(9256):633   [PMID:  11558506 ]
ACP J Club. 2001 May-Jun;134(3):91
Lancet. 2001 May 26;357(9269):1705-6   [PMID:  11428363 ]
Lancet. 2001 Feb 24;357(9256):632-3   [PMID:  11558505 ]
Lancet. 2001 Feb 24;357(9256):631-2; author reply 632-3   [PMID:  11558503 ]
Lancet. 2001 Feb 24;357(9256):631; author reply 632-3   [PMID:  11558504 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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