See also:

SUVIMAX study, 2005	TRC10365
	download pdf: combination | antioxydants for cardiovascular prevention

Treatments

Studied treatment	single daily capsule of combination of antioxydants: 120 mg of ascorbic acid, 30 mg of vitamin E, 6 mg of beta carotene, 100 ìg of selenium, and 20 mg of zinc
Control treatment	matched placebo

Patients

Patients	women aged 35-60 years and men aged 45-60 years
Exclusion criteria	disease likely to hinder active participation or threatened 5-year survival; previous regular supplementation with any of the vitamins or minerals in the supplement provided; extreme beliefs or behavior regarding diet
Baseline characteristics	Women (%) 61%  age (yr) male: 51.3, female: 46.6  Body mass index 24.05

Method and design

Randomized effectives	6481 / 6536 (studied vs. control)
Design	Parallel groups
Blinding	double-blind
Follow-up duration	7.5 years
Lost to follow-up	6%
Number of centre	media campaign
Geographic area	France
Primary endpoint	not defined
Studied endpoints	Ischemic cardiovascular disease incidence, Cancer incidence, Mortality

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

cardiovascular events

134 / 6481
137 / 6536
0,99 [0,78;1,25]

All cause death

76 / 6481
98 / 6536
0,78 [0,58;1,05] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
cardiovascular events	134 / 6481 (2,1%)	137 / 6536 (2,1%)	0,99	[0,78;1,25]	Ischemic cardiovascular disease	13108
All cause death	76 / 6481 (1,2%)	98 / 6536 (1,5%)	0,78	[0,58;1,05]		13108
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 13108: Hercberg S, Galan P, Preziosi P, Bertrais S, Mennen L, Malvy D, Roussel AM, Favier A, Briançon SThe SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals.Arch Intern Med 2004 Nov 22;164:2335-42 0:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 7.5 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
cardiovascular events	2,07%	2,10%	-0,03%
All cause death	1,17%	1,50%	-0,33%

Meta-analysis of all similar trials:

antioxydants in cardiovascular prevention for all type of patients

antioxydants in cardiovascular prevention for primary prevention

Reference(s)

TrialResults-center ID	TRC10365
Trials register #	NA

• Hercberg S, Galan P, Preziosi P, Bertrais S, Mennen L, Malvy D, Roussel AM, Favier A, Briançon S. The SU.VI.MAX Study: a randomized, placebo-controlled trial of the health effects of antioxidant vitamins and minerals.. Arch Intern Med 2004 Nov 22;164:2335-42
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• Hercberg S, Preziosi P, Briançon S, Galan P, Triol I, Malvy D, Roussel AM, Favier A. A primary prevention trial using nutritional doses of antioxidant vitamins and minerals in cardiovascular diseases and cancers in a general population: the SU.VI.MAX study--design, methods, and participant characteristics. SUpplementation en VItamines et Minéraux AntioXydants.. Control Clin Trials 1998;19:336-51
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• Hercberg S, Galan P, Preziosi P, Roussel AM, Arnaud J, Richard MJ, Malvy D, Paul-Dauphin A, Briançon S, Favier A. Background and rationale behind the SU.VI.MAX Study, a prevention trial using nutritional doses of a combination of antioxidant vitamins and minerals to reduce cardiovascular diseases and cancers. SUpplementation en VItamines et Minéraux AntioXydants Study.. Int J Vitam Nutr Res 1998;68:3-20
  Pubmed | Hubmed | Fulltext

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