SU.FOL.OM3 trial

SU.FOL.OM3 study,	TRC11320
[ISRCTN41926726]	download pdf: folic acid, vit B12 and vit B6 \| plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	supplementation with natural foLate, vitamin B6 and B12 5-methyl-THF (560 �g), vitamin B6 (3 mg) and B12 (20 �g)
Control treatment	placebo
Remarks	factorial design with as 2nd comparison omega 3 fatty acids (600 mg of eicosapentanoic acid and docosahexaenoic acid at a ratio of 2:1) versus placebo

Patients

patients with coronary or cerebral event within the previous 12 months

Exclusion criteria

Age <45 years or >80 years; Cardiovascular pathology not well defined; Patients that are incapable of understanding the study protocol; Patients with a pathology that might interfere with homocysteine or omega-3 fatty acid metabolism, in particular those that use methotrexate for the treatment of a cancer or rheumatoid arthritis and chronic renal failure (plasma level of creatinine >200 �mol/l or creatinine clearance <40 ml/min); Patients with a non-cardiovascular pathology with a suspected survival time less than the 5 years period of the study (solid cancer, evolved dementia, leukemia etc.)

Method and design

Randomized effectives	1242 / 1259 (studied vs. control)
Design	Parallel groups
Blinding	double-blind
Geographic area	France
Primary endpoint	MI, stroke, CV death

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
Major cardiovascular events	75 / 1242 (6,0%)	82 / 1259 (6,5%)	0,93	[0,68;1,26]
Non-fatal myocardial infarction	28 / 1242 (2,3%)	32 / 1259 (2,5%)	0,89	[0,54;1,46]
All coronary events	49 / 1242 (3,9%)	55 / 1259 (4,4%)	0,90	[0,62;1,32]
Stroke	21 / 1242 (1,7%)	36 / 1259 (2,9%)	0,59	[0,35;1,01]
All cerebrovascular events	35 / 1242 (2,8%)	48 / 1259 (3,8%)	0,74	[0,48;1,13]
All revascularisations	155 / 1242 (12,5%)	153 / 1259 (12,2%)	1,03	[0,83;1,27]
Other cardiovascular events	224 / 1242 (18,0%)	212 / 1259 (16,8%)	1,07	[0,90;1,27]
All deaths	72 / 1242 (5,8%)	45 / 1259 (3,6%)	1,62	[1,13;2,33]

Endpoints used by the meta-analysis and data retained for this trial

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

All cause death

72 / 1242
45 / 1259
classic 1,62 [1,13;2,33]

stroke (fatal and non fatal)

21 / 1242
36 / 1259
0,59 [0,35;1,01]

Non fatal MI

28 / 1242
32 / 1259
0,89 [0,54;1,46]

Non fatal MI

49 / 1242
55 / 1259
0,90 [0,62;1,32]

cardiovascular events

75 / 1242
82 / 1259
0,93 [0,68;1,26] 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	72 / 1242 (5,8%)	45 / 1259 (3,6%)	1,62	[1,13;2,33]	All deaths
Non fatal MI	49 / 1242 (3,9%)	55 / 1259 (4,4%)	0,90	[0,62;1,32]	All coronary events
cardiovascular events	75 / 1242 (6,0%)	82 / 1259 (6,5%)	0,93	[0,68;1,26]	Major cardiovascular events
Non fatal MI	28 / 1242 (2,3%)	32 / 1259 (2,5%)	0,89	[0,54;1,46]	Non-fatal myocardial infarction
stroke (fatal and non fatal)	21 / 1242 (1,7%)	36 / 1259 (2,9%)	0,59	[0,35;1,01]	Stroke
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of )
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
All cause death	5,80%	3,57%	2,2%
Non fatal MI	3,95%	4,37%	-0,42%
cardiovascular events	6,04%	6,51%	-0,47%
Non fatal MI	2,25%	2,54%	-0,29%
stroke (fatal and non fatal)	1,69%	2,86%	-1,17%

Meta-analysis of all similar trials:

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

Reference(s)

TrialResults-center ID	TRC11320
Trials register #	ISRCTN41926726