women’s health study: vitamin e in primary prevention presented at american college of cardiology...
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Women’s Health Study: Women’s Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Women’s Health Study: Women’s Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Presented atPresented atAmerican College of CardiologyAmerican College of Cardiology
Scientific Sessions 2005Scientific Sessions 2005
Presented by Dr. Julie E. BuringPresented by Dr. Julie E. Buring
Orlando, FloridaOrlando, Florida
Women’s Health Study: Vitamin E in Primary PreventionWomen’s Health Study: Vitamin E in Primary PreventionWomen’s Health Study: Vitamin E in Primary PreventionWomen’s Health Study: Vitamin E in Primary Prevention
www. Clinical trial results.org
Vitamin E600 IU on alternate days
n=19,937
Vitamin E600 IU on alternate days
n=19,937
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
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
Presented at ACC 2005Presented at ACC 2005
39,876 initially healthy† women age ≥ 45 Randomized, blinded, factorial
39,876 initially healthy† women age ≥ 45 Randomized, blinded, factorial
Placebo n=19,939Placebo
n=19,939
†: 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.
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
www. Clinical trial results.org
Primary Composite Endpoint:Major Cardiovascular Events
Relative Risk [RR] 0.9395% CI 0.82-1.05
p=0.26
482517
0
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Vitamin E Placebo
482517
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Vitamin E Placebo
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
• 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.
196
106
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Vitamin E Placebo
196
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246
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Vitamin E Placebo
Composite Components:
MIp=0.96
Strokep=0.82
Death from CV Causes
p=0.03
Presented at ACC 2005Presented at ACC 2005
www. Clinical trial results.org
Ischemic Strokep=0.88
Hemorrhagic Strokep=0.68
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Components of Stroke
Presented at ACC 2005Presented at ACC 2005
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Vitamin E Placebo
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Vitamin E Placebo
•There was no difference in total stroke•There was no difference in total stroke
www. Clinical trial results.org
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Women's Health Study: Women's Health Study: Vitamin E in Primary PreventionVitamin E in Primary Prevention
Side Effects: Gastrointestinal BleedingSide Effects: Gastrointestinal Bleeding
•Gastrointestinal bleed rate did not differ between the vitamin E group and the placebo group
•Gastrointestinal bleed rate did not differ between the vitamin E group and the placebo group
4.2 4.1
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%
Vitamin E Placebo
4.2 4.1
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%
Vitamin E Placebo
p=0.77p=0.77
Presented at ACC 2005Presented at ACC 2005
www. Clinical trial results.org
• 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.
• 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.
Women’s Health Study: Women’s Health Study: Vitamin E in Primary Prevention: SummaryVitamin E in Primary Prevention: Summary
Women’s Health Study: Women’s Health Study: Vitamin E in Primary Prevention: SummaryVitamin E in Primary Prevention: Summary
Presented at ACC 2005Presented at ACC 2005