See also:

NORVIT (folic acid + B12) (Bonaa) study, 2006	TRC3437
[NCT00266487]	download pdf: folic acid, B12 | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	folic acid 0.8mg and B12 0.4 mg daily
Control treatment	no folic acid and B12
Concomittant treatment	patients received vit B6 or its placebo (factorial design)
Remarks	patients received also Vit B6 or placebo in a two by two factorial design

Patients

Patients	men and women who had had an acute myocardial infarction within seven days before
Exclusion criteria	coexisting disease associated with a life expectancy of less than four years, prescribed treatment with B vitamins or untreated vitamin B deficiency, or inability to follow the protocol
Baseline characteristics	Age (yr) 63 y  Male sex 74%  BMI 26.2  diabetes (%) 10%

Method and design

Randomized effectives	1872 / 1877 (studied vs. control)
Design	Factorial plan
Blinding	double-blind
Follow-up duration	36 months
Number of centre	multicenter
Geographic area	Norway
Hypothesis	Superiority
Primary endpoint	CV events (fatal and non ftala MI, stroke, sudden death)
Remarks

Remarks / Comments

Results

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

All cause death

184 / 1872
181 / 1877
1,02 [0,84;1,24]

cardiac death

115 / 1872
120 / 1877
0,96 [0,75;1,23]

Cancer

79 / 1872
65 / 1877
1,22 [0,88;1,68]

cardiovascular events

369 / 1872
347 / 1877
1,07 [0,93;1,22]

stroke (fatal and non fatal)

49 / 1872
49 / 1877
1,00 [0,68;1,48]

Non fatal MI

245 / 1872
217 / 1877
1,13 [0,95;1,34] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
All cause death	184 / 1872 (9,8%)	181 / 1877 (9,6%)	1,02	[0,84;1,24]
cardiovascular events	369 / 1872 (19,7%)	347 / 1877 (18,5%)	1,07	[0,93;1,22]		0
Non fatal MI	245 / 1872 (13,1%)	217 / 1877 (11,6%)	1,13	[0,95;1,34]
stroke (fatal and non fatal)	49 / 1872 (2,6%)	49 / 1877 (2,6%)	1,00	[0,68;1,48]		0
cardiac death	115 / 1872 (6,1%)	120 / 1877 (6,4%)	0,96	[0,75;1,23]
Cancer	79 / 1872 (4,2%)	65 / 1877 (3,5%)	1,22	[0,88;1,68]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 36 months)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
All cause death	9,83%	9,64%	0,19%
cardiovascular events	19,71%	18,49%	1,2%
Non fatal MI	13,09%	11,56%	1,5%
stroke (fatal and non fatal)	2,62%	2,61%	0,01%
cardiac death	6,14%	6,39%	-0,25%
Cancer	4,22%	3,46%	0,76%

Meta-analysis of all similar trials:

plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC3437
Trials register #	NCT00266487
Study web site link	http://www.medscape.com/viewarticle/512905

• B�naa KH, Nj�lstad I, Ueland PM, Schirmer H, Tverdal A, Steigen T, Wang H, Nordrehaug JE, Arnesen E, Rasmussen K. Homocysteine lowering and cardiovascular events after acute myocardial infarction.. N Engl J Med 2006;354:1578-88 - 10.1056/NEJMoa055227
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