See also:

NORVIT (vit B6) (Bonaa) study, 2006	TRC4370
[NCT00266487]	download pdf: vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	vit B6 40 mg daily
Control treatment	no vit B6
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	1871 / 1878 (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

196 / 1871
169 / 1878
1,16 [0,96;1,42]

stroke (fatal and non fatal)

43 / 1871
55 / 1878
0,78 [0,53;1,16]

Cancer

65 / 1871
79 / 1878
0,83 [0,60;1,14]

Non fatal MI

245 / 1871
217 / 1878
1,13 [0,96;1,34]

Non fatal MI

343 / 1871
300 / 1878
1,15 [1,00;1,32]

cardiovascular events

376 / 1871
340 / 1878
1,11 [0,97;1,27]

cardiac death

129 / 1871
106 / 1878
1,22 [0,95;1,57] 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	196 / 1871 (10,5%)	169 / 1878 (9,0%)	1,16	[0,96;1,42]
Non fatal MI	343 / 1871 (18,3%)	300 / 1878 (16,0%)	1,15	[1,00;1,32]		0
cardiovascular events	376 / 1871 (20,1%)	340 / 1878 (18,1%)	1,11	[0,97;1,27]		0
Non fatal MI	245 / 1871 (13,1%)	217 / 1878 (11,6%)	1,13	[0,96;1,34]
stroke (fatal and non fatal)	43 / 1871 (2,3%)	55 / 1878 (2,9%)	0,78	[0,53;1,16]		0
Cancer	65 / 1871 (3,5%)	79 / 1878 (4,2%)	0,83	[0,60;1,14]
cardiac death	129 / 1871 (6,9%)	106 / 1878 (5,6%)	1,22	[0,95;1,57]
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	10,48%	9,00%	1,5%
Non fatal MI	18,33%	15,97%	2,4%
cardiovascular events	20,10%	18,10%	2,0%
Non fatal MI	13,09%	11,55%	1,5%
stroke (fatal and non fatal)	2,30%	2,93%	-0,63%
Cancer	3,47%	4,21%	-0,73%
cardiac death	6,89%	5,64%	1,3%

Meta-analysis of all similar trials:

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

Reference(s)

TrialResults-center ID	TRC4370
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
  Pubmed | Hubmed | Fulltext

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