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NORVIT (folic acid, B12 and vit B6) (Bonaa) study, 2006	TRC4371
[NCT00266487]	download pdf: folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	0.8 mg of folic acid, 0.4 mg of vitamin B12, and 40 mg of vitamin B6
Control treatment	placebo
Remarks	factorial design of folic acid plus B12 and B6

Patients

Patients	men and women who had had an acute myocardial infarction within seven days
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	937 / 943 (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)

Results

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

stroke (fatal and non fatal)

21 / 937
27 / 943
0,78 [0,45;1,37]

Non fatal MI

132 / 937
104 / 943
1,28 [1,00;1,62]

Non fatal MI

182 / 937
153 / 943
1,20 [0,99;1,45]

cardiac death

68 / 937
59 / 943
1,16 [0,83;1,62]

All cause death

104 / 937
89 / 943
1,18 [0,90;1,54]

Cancer

40 / 937
40 / 943
1,01 [0,66;1,55]

cardiovascular events

201 / 937
172 / 943
1,18 [0,98;1,41] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
Non fatal MI	182 / 937 (19,4%)	153 / 943 (16,2%)	1,20	[0,99;1,45]		0
Cancer	40 / 937 (4,3%)	40 / 943 (4,2%)	1,01	[0,66;1,55]
Non fatal MI	132 / 937 (14,1%)	104 / 943 (11,0%)	1,28	[1,00;1,62]
All cause death	104 / 937 (11,1%)	89 / 943 (9,4%)	1,18	[0,90;1,54]
cardiovascular events	201 / 937 (21,5%)	172 / 943 (18,2%)	1,18	[0,98;1,41]		0
cardiac death	68 / 937 (7,3%)	59 / 943 (6,3%)	1,16	[0,83;1,62]
stroke (fatal and non fatal)	21 / 937 (2,2%)	27 / 943 (2,9%)	0,78	[0,45;1,37]		0
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.
Non fatal MI	19,42%	16,22%	3,2%
Cancer	4,27%	4,24%	0,03%
Non fatal MI	14,09%	11,03%	3,1%
All cause death	11,10%	9,44%	1,7%
cardiovascular events	21,45%	18,24%	3,2%
cardiac death	7,26%	6,26%	1,0%
stroke (fatal and non fatal)	2,24%	2,86%	-0,62%

Meta-analysis of all similar trials:

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

Reference(s)

TrialResults-center ID	TRC4371
Trials register #	NCT00266487

• 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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