WENBIT (vit B6) trial

WENBIT (vit B6) study, 2008	TRC9992
[NCT00354081]	download pdf: vit B6 \| plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	vit B6 40mg daily
Control treatment	placebo
Remarks	4 arms: folic acid+B12+B6, folic ac+B12, B6, placebo (2x2 factorial design B6 vs PBO, folic ac+B12 vs pbo)

adult participants undergoing coronary angiography

Exclusion criteria

alcohol abuse; serious mental illness; cancer

Baseline characteristics

Randomized effectives	772 / 780 (studied vs. control)
Design	Factorial plan
Blinding	double blind
Follow-up duration	38.4 mo
Number of centre	2
Geographic area	Norway
Hypothesis	Superiority
Primary endpoint	all death, MI, unstable angina, stroke
Remarks

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

All cause death

28 / 771
30 / 779
0,94 [0,57;1,56]

cardiovascular events

106 / 771
97 / 779
1,10 [0,85;1,43]

Non fatal MI

55 / 771
58 / 779
0,96 [0,67;1,37]

Cancer

38 / 771
31 / 779
1,24 [0,78;1,97] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
All cause death	28 / 771 (3,6%)	30 / 779 (3,9%)	0,94	[0,57;1,56]		11313
Non fatal MI	55 / 771 (7,1%)	58 / 779 (7,4%)	0,96	[0,67;1,37]		11313
cardiovascular events	106 / 771 (13,7%)	97 / 779 (12,5%)	1,10	[0,85;1,43]		11313
Cancer	38 / 771 (4,9%)	31 / 779 (4,0%)	1,24	[0,78;1,97]		11313
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 11313: Ebbing M, Bleie �, Ueland PM, Nordrehaug JE, Nilsen DW, Vollset SE, Refsum H, Pedersen EK, Nyg�rd OJAMA 2008;300:795-804 13312: B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial.Lancet Neurol 2010;:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 38.4 mo)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
All cause death	3,63%	3,85%	-0,22%
Non fatal MI	7,13%	7,45%	-0,31%
cardiovascular events	13,75%	12,45%	1,3%
Cancer	4,93%	3,98%	0,95%

Meta-analysis of all similar trials:

TrialResults-center ID	TRC9992
Trials register #	NCT00354081