Women’s Health Study: Vitamin E in Primary Prevention Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Julie E. Buring Orlando, Florida Women’s Health Study: Vitamin E in Primary Prevention

www. Clinical trial results.org Vitamin E 600 IU on alternate days  n=19,937 Vitamin E 600 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 ,876 initially healthy † women age ≥ 45 Randomized, blinded, factorial 39,876 initially healthy † women age ≥ 45 Randomized, blinded, factorial Placebo  n=19,939 Placebo  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: Vitamin E in Primary Prevention

www. Clinical trial results.org Primary Composite Endpoint: Major Cardiovascular Events Relative Risk [RR] % CI p=0.26 Women's Health Study: Vitamin 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. Composite Components: MI p=0.96 Stroke p=0.82 Death from CV Causes p=0.03 Presented at ACC 2005

www. Clinical trial results.org Ischemic Stroke p=0.88 Hemorrhagic Stroke p=0.68 Women's Health Study: Vitamin E in Primary Prevention Components of Stroke Presented at ACC 2005 There was no difference in total stroke

www. Clinical trial results.org Women's Health Study: Vitamin E in Primary Prevention Side Effects: Gastrointestinal Bleeding Gastrointestinal bleed rate did not differ between the vitamin E group and the placebo group p=0.77 Presented 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: Vitamin E in Primary Prevention: Summary Presented at ACC 2005