The Women's Angiographic Vitamin and Estrogen Trial
(WAVE)
Objectives:
Determine the efficacy of of estrogen replacement and
antioxidant vitamins for preventing angiographic progression of coronary artery
disease.
Background:
Prior to the WAVE trial, Hormone Replacement Therapy
(HRT) and antioxidant vitamins were widely used for primary and secondary
prevention in postmenopausal women with coronary disease, but clincal trials
had not yet demonstrated benefit to support these therapies.
Subjects:
Seven clinical centers randomized 423 postmenopausal
women with one or more angiographically documented coronary vessel stenosis of
15-75%. The study design was a double blind, 2X2 factorial consisting of active
hormone replacement therapy or placebo and active vitamins E and C or their
placebos. Randomization was stratified for clinical center and prior
hysterectomy. Women in the active arm of the HRT treatment received either
conjugated equine estrogen (prior history of hysterectomy) or conjugated equine
estrogen and medroxypregesterone acetate (women with a uterus). Women assigned
to the active arm of the vitamin therapy took two capsules daily of vitamin E
and two tablets daily of vitamin C. The primary endpoint was mean change in
minimum lumen diameter as determined by angiography.
Conclusions:
After a mean interval of 2.8 years, neither HRT nor
antioxidant vitamin supplements provided cardiovascular benefit in
postmenopausal women with coronary disease. Instead, a potential for harm was
suggested with each treatment.(JAMA 2002; 288:2432-40)
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Study Website |
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Study Documentation |
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Data Distribution Agreement |
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