See also:

ASAP study, 2000	TRC11242
	download pdf: vitamin E | antioxydants for cardiovascular prevention

Treatments

Studied treatment	d-alpha-tocopherol 91 mg (136 IU) twice daily
Control treatment	placebo

Patients

Patients	smoking and nonsmoking men and postmenopausal women aged 45-69 years with serum cholesterol >= 5.0 mmol/l
Inclusion criteria	hypercholesterolemiadefined as serum cholesterol >=5.0 mmol/L (193 mg/dL) at screening
Exclusion criteria	regular intake of antioxidants, acetosalicylate, or any other drug with antioxidative properties, severe obesity (body mass index >32 kg/m2), type 1 diabetes, uncontrolled hypertension (sitting diastolic blood pressure >105 mm Hg), any condition limiting mobility, or severe disease shortening life expectancy; premenopausal women; oral estrogen therapy
Baseline characteristics	Women (%) 51%  age (yr) 59.7 y

Method and design

Randomized effectives	260 / 260 (studied vs. control)
Design	Factorial plan
Blinding	double-blind
Follow-up duration	3 years
Number of centre	NA
Geographic area	Finland
Hypothesis	Superiority
Primary endpoint	carotid artery mean intima-media thickness
Remarks	after the double-blind 3-year period, the study was continued for another 3 years as an open study

Results

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

All cause death

4 / 260
2 / 260
classic 2,00 [0,37;10,82] 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	4 / 260 (1,5%)	2 / 260 (0,8%)	2,00	[0,37;10,82]		13135
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 13135: Salonen JT, Nyyss�nen K, Salonen R, Lakka HM, Kaikkonen J, Porkkala-Sarataho E, Voutilainen S, Lakka TA, Rissanen T, Leskinen L, Tuomainen TP, Valkonen VP, Ristonmaa U, Poulsen HEAntioxidant Supplementation in Atherosclerosis Prevention (ASAP) study: a randomized trial of the effect of vitamins E and C on 3-year progression of carotid atherosclerosis.J Intern Med 2000;248:377-86 0:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 3 years)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
All cause death	1,54%	7,69‰	0,77%

Meta-analysis of all similar trials:

antioxydants in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC11242
Trials register #	NA

• Lepp�l� JM, Virtamo J, Fogelholm R, Huttunen JK, Albanes D, Taylor PR, Heinonen OP. Controlled trial of alpha-tocopherol and beta-carotene supplements on stroke incidence and mortality in male smokers.. Arterioscler Thromb Vasc Biol 2000;20:230-5
  Pubmed | Hubmed | Fulltext
• Salonen JT, Nyyss�nen K, Salonen R, Lakka HM, Kaikkonen J, Porkkala-Sarataho E, Voutilainen S, Lakka TA, Rissanen T, Leskinen L, Tuomainen TP, Valkonen VP, Ristonmaa U, Poulsen HE. Antioxidant Supplementation in Atherosclerosis Prevention (ASAP) study: a randomized trial of the effect of vitamins E and C on 3-year progression of carotid atherosclerosis.. J Intern Med 2000;248:377-86
  Pubmed | Hubmed | Fulltext
• Salonen RM, Nyyss�nen K, Kaikkonen J, Porkkala-Sarataho E, Voutilainen S, Rissanen TH, Tuomainen TP, Valkonen VP, Ristonmaa U, Lakka HM, Vanharanta M, Salonen JT, Poulsen HE. Six-year effect of combined vitamin C and E supplementation on atherosclerotic progression: the Antioxidant Supplementation in Atherosclerosis Prevention (ASAP) Study.. Circulation 2003;107:947-53
  Pubmed | Hubmed | Fulltext

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