Women’s Health Study study - description and results

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This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - antiplatelets drug - all type of patients

cardiovascular prevention - antiplatelets drug - primary prevention

cardiovascular prevention - antiplatelets drug - patients without established disease

cardiovascular prevention - antithrombotics - all type of patients

Related trials

AAA, 2009 - aspirin vs placebo

JPAD, 2008 - aspirin vs no treatment

POPADAD aspirin, 2008 - aspirin vs placebo

CHARISMA, 2006 - clopidogrel + aspirin vs aspirin

Women’s Health Study, 2005 - aspirin vs placebo

Primary Prevention Project, 2001 - aspirin vs no treatment

Thrombosis Prevention trial (W alone), 1998 - warfarin vs placebo

HOT, 1998 - aspirin vs placebo

Thrombosis Prevention trial (W+A), 1998 - warfarin + aspirin vs placebo

Thrombosis Prevention Trial, 1998 - aspirin vs placebo

CAPRIE, 1996 - clopidogrel vs aspirin

Physicians Health Study, 1989 - aspirin vs placebo

British Doctor’s Trial, 1988 - aspirin vs no treatment

Treatments

Studied treatment	aspirin 100mg daily
Control treatment	placebo
Remarks	factorial esign: vitamin E vs placebo

Patients

initially healthy women 45 years of age or older

Inclusion criteria

women 45 years of age or older; no history of coronary heart disease, cerebrovascular disease, cancer (except nonmelanoma skin cancer), or other major chronic illness; no history of side effects to any of the study medications; not taking aspirin or nonsteroidal antiinflammatory medications (NSAIDs) more than once a week; not taking anticoagulants or corticosteroids; and not taking individual supplements of vitamin A, E, or beta carotene more than once a week.

Baseline characteristics

Age (yr)	54.6
Body-mass index	26.05
Hypertension (%)	25.85
Diabetes (%)	2.6
Hyperlipidemia (%)	29.5
Female (%)	100

Method and design

Randomized effectives	19934 / 19942 (studied vs. control)
Design	Factorial plan
Blinding	Double blind
Follow-up duration	10.1 y mean (range 8.2 to 10.9
Hypothesis	Superiority
Primary endpoint	nonfatal myocardial infarction, nonfatal stroke, and death from cardiovascular causes

Results

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

Coronary event

243 / 19934
250 / 19942
0,97 [0,82;1,16]

stroke (fatal and non fatal)

221 / 19934
266 / 19942
0,83 [0,70;0,99]

Haemmorhagic stroke

51 / 19934
41 / 19942
1,24 [0,83;1,88]

Cardiovascular events

477 / 19934
522 / 19942
0,91 [0,81;1,03]

Peptic ulcer

542 / 19934
413 / 19942
1,31 [1,16;1,49]

Hematuria

3039 / 19934
2879 / 19942
1,06 [1,01;1,11]

ischemic stroke

170 / 19934
221 / 19942
0,77 [0,63;0,94]

Coronary death

14 / 19934
12 / 19942
classic 1,17 [0,54;2,52]

All cause death

609 / 19934
642 / 19942
0,95 [0,85;1,06]

Gastrointestinal Bleeding

910 / 19934
751 / 19942
1,21 [1,10;1,33]

myocardial infarction (fatal and non fatal)

198 / 19934
193 / 19942
1,03 [0,84;1,25]

Major gastrointestinal bleeding

127 / 19934
91 / 19942
1,40 [1,07;1,83]

Non fatal MI

184 / 19934
181 / 19942
1,02 [0,83;1,25] 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
Coronary event	243 / 19934 (1,2%)	250 / 19942 (1,3%)	0,97	[0,82;1,16]		10916
stroke (fatal and non fatal)	221 / 19934 (1,1%)	266 / 19942 (1,3%)	0,83	[0,70;0,99]
Haemmorhagic stroke	51 / 19934 (0,3%)	41 / 19942 (0,2%)	1,24	[0,83;1,88]
Cardiovascular events	477 / 19934 (2,4%)	522 / 19942 (2,6%)	0,91	[0,81;1,03]
Peptic ulcer	542 / 19934 (2,7%)	413 / 19942 (2,1%)	1,31	[1,16;1,49]
Hematuria	3039 / 19934 (15,2%)	2879 / 19942 (14,4%)	1,06	[1,01;1,11]
Non fatal MI	184 / 19934 (0,9%)	181 / 19942 (0,9%)	1,02	[0,83;1,25]		10916
ischemic stroke	170 / 19934 (0,9%)	221 / 19942 (1,1%)	0,77	[0,63;0,94]		10916
Coronary death	14 / 19934 (0,1%)	12 / 19942 (0,1%)	1,17	[0,54;2,52]	fatal MI
All cause death	609 / 19934 (3,1%)	642 / 19942 (3,2%)	0,95	[0,85;1,06]
Gastrointestinal Bleeding	910 / 19934 (4,6%)	751 / 19942 (3,8%)	1,21	[1,10;1,33]
myocardial infarction (fatal and non fatal)	198 / 19934 (1,0%)	193 / 19942 (1,0%)	1,03	[0,84;1,25]
Major gastrointestinal bleeding	127 / 19934 (0,6%)	91 / 19942 (0,5%)	1,40	[1,07;1,83]	requiring transfusion	0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 10916: Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti AAspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials.Lancet 2009 May 30;373:1849-60 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Coronary event	1,22%	1,25%	-0,3‰
stroke (fatal and non fatal)	1,11%	1,33%	-2,3‰
Haemmorhagic stroke	2,56‰	2,06‰	0,5‰
Cardiovascular events	2,39%	2,62%	-2,2‰
Peptic ulcer	2,72%	2,07%	6,5‰
Hematuria	15,25%	14,44%	8,1‰
Non fatal MI	9,23‰	9,08‰	0,2‰
ischemic stroke	8,53‰	1,11%	-2,6‰
Coronary death	0,70‰	0,60‰	0,1‰
All cause death	3,06%	3,22%	-1,6‰
Gastrointestinal Bleeding	4,57%	3,77%	8,0‰
myocardial infarction (fatal and non fatal)	9,93‰	9,68‰	0,3‰
Major gastrointestinal bleeding	6,37‰	4,56‰	1,8‰

Reference(s)

Trials register #

Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson JE, Hennekens CH, Buring JE. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women.. N Engl J Med 2005 Mar 31;352:1293-304
Pubmed | Hubmed | Fulltext

Women’s Health Study study, 2005

Treatments

Patients

Method and design

Results

Reference(s)