PHS II vitamin C trial

PHS II vitamin C study, 2008	TRC8811
[NCT00270647]	download pdf: vitamin C \| antioxydants for cardiovascular prevention

Treatments

Studied treatment	vitamin C 500mg daily
Control treatment	placebo
Remarks	2x2x2x2 factorial trial evaluating vitamin E (400 IU synthetic alpha-tocopherol), vitaminC(500mg synthetic ascorbic acid), a multivitamin (Centrum Silver daily; Wyeth Pharmaceuticals) and beta carotene (50mg, Lurotin on alternate days)

US male physicians aged 50 years or older

Inclusion criteria

men with a history of myocardial infarction (MI), stroke, or cancer were eligible

Exclusion criteria

history of cirrhosis; active liver disease; anticoagulants; serious illness that might preclude participation

Baseline characteristics

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death)	619 / 7329 (8,4%)	626 / 7312 (8,6%)	0,99	[0,89;1,10]
fatal and non fatal MI	260 / 7329 (3,5%)	251 / 7312 (3,4%)	1,03	[0,87;1,23]
Myocardial infarction death	30 / 7329 (0,4%)	22 / 7312 (0,3%)	1,36	[0,79;2,36]
fatal and non fatal stroke	218 / 7329 (3,0%)	246 / 7312 (3,4%)	0,88	[0,74;1,06]
Stroke death	44 / 7329 (0,6%)	57 / 7312 (0,8%)	0,77	[0,52;1,14]
Ischemic stroke	180 / 7329 (2,5%)	207 / 7312 (2,8%)	0,87	[0,71;1,06]
Hemorrhagic stroke	30 / 7329 (0,4%)	32 / 7312 (0,4%)	0,94	[0,57;1,54]
Cardiovascular death	256 / 7329 (3,5%)	253 / 7312 (3,5%)	1,01	[0,85;1,20]
Congestive heart failure	293 / 7329 (4,0%)	290 / 7312 (4,0%)	1,01	[0,86;1,18]
Angina	718 / 7329 (9,8%)	765 / 7312 (10,5%)	0,94	[0,85;1,03]
Revascularization	678 / 7329 (9,3%)	706 / 7312 (9,7%)	0,96	[0,87;1,06]
Total mortality	857 / 7329 (11,7%)	804 / 7312 (11,0%)	1,06	[0,97;1,16]

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

stroke (fatal and non fatal)

218 / 7329
246 / 7312
0,88 [0,74;1,06]

Cardiovascular death

256 / 7329
253 / 7312
1,01 [0,85;1,20]

Haemmorhagic stroke

30 / 7329
32 / 7312
0,94 [0,57;1,54]

All cause death

857 / 7329
804 / 7312
1,06 [0,97;1,16]

ischemic stroke

180 / 7329
207 / 7312
0,87 [0,71;1,06]

cardiovascular events

619 / 7329
626 / 7312
0,99 [0,89;1,10] 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
stroke (fatal and non fatal)	218 / 7329 (3,0%)	246 / 7312 (3,4%)	0,88	[0,74;1,06]		0
ischemic stroke	180 / 7329 (2,5%)	207 / 7312 (2,8%)	0,87	[0,71;1,06]		0
Cardiovascular death	256 / 7329 (3,5%)	253 / 7312 (3,5%)	1,01	[0,85;1,20]		0
cardiovascular events	619 / 7329 (8,4%)	626 / 7312 (8,6%)	0,99	[0,89;1,10]		0
All cause death	857 / 7329 (11,7%)	804 / 7312 (11,0%)	1,06	[0,97;1,16]		0
Haemmorhagic stroke	30 / 7329 (0,4%)	32 / 7312 (0,4%)	0,94	[0,57;1,54]		0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 8 years (mean))
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
stroke (fatal and non fatal)	2,97%	3,36%	-0,39%
ischemic stroke	2,46%	2,83%	-0,37%
Cardiovascular death	3,49%	3,46%	0,03%
cardiovascular events	8,45%	8,56%	-0,12%
All cause death	11,69%	11,00%	0,70%
Haemmorhagic stroke	4,09‰	4,38‰	-0,03%

Meta-analysis of all similar trials:

TrialResults-center ID	TRC8811
Trials register #	NCT00270647