Women

1
Womens Health Study Vitamin E in Primary
Prevention
Womens Health Study Vitamin E in Primary
Prevention
Presented at American College of
Cardiology Scientific Sessions 2005 Presented by
Dr. Julie E. Buring Orlando, Florida
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Women's Health Study Vitamin E in Primary
Prevention
39,876 initially healthy women age 45
Randomized, blinded, factorial

• Placebo
• n19,939

• Vitamin E
• 600 IU on alternate days
• n19,937

• Primary Endpoints (mean 10.1 years)
• Combined endpoint of nonfatal MI, nonfatal
  stroke, and total cardiovascular death
• Incidence of total malignant neoplasms of
  epithelial cell origin

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 (or were willing
to forego their use during the trial) not taking
anticoagulants or corticosteroids and not taking
individual supplements of vitamin A, E, or beta
carotene more than once a week.
Presented at ACC 2005
3
Women's Health Study Vitamin E in Primary
Prevention
Primary Composite Endpoint Major Cardiovascular
Events Relative Risk RR 0.93 95 CI
0.82-1.05 p0.26
Composite Components
Stroke p0.82
MI p0.96
Death from CV Causes p0.03

• Among the individual components of the composite
  endpoint, there was no difference in MI or
  stroke, but total cardiovascular death was
  significantly lower in the vitamin E group.
• In subgroup analysis, there was no modification
  of the primary endpoint results among women with
  high level of compliance, women using HRT, or by
  menopausal status.

Presented at ACC 2005
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Women's Health Study Vitamin E in Primary
Prevention
Components of Stroke
Ischemic Stroke p0.88
Hemorrhagic Stroke p0.68

• There was no difference in total stroke

Presented at ACC 2005
5
Women's Health Study Vitamin E in Primary
Prevention
Side Effects Gastrointestinal Bleeding
p0.77

• Gastrointestinal bleed rate did not differ
  between the vitamin E group and the placebo group

Presented at ACC 2005
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Womens Health Study Vitamin E in Primary
Prevention Summary

• Among initially healthy women, treatment with
  vitamin E was not associated with a significant
  difference in the primary endpoint of major
  cardiovascular events compared with placebo at a
  mean 10 year follow-up.
• Randomized trials of vitamin E for secondary
  prevention did not demonstrate benefit as shown
  in the large Heart Protection Study. These
  findings, along with data from the earlier Heart
  Protection Study, do not support use of vitamin E
  for prevention of cardiovascular disease.
• The reduction of cardiovascular death associated
  with vitamin E use will require further
  exploration, as there was no decrease in fatal MI
  or fatal stroke.

Presented at ACC 2005