Background: Heart disease is a major cause of illness and death in women. To understand better the role of estrogen in the treatment and prevention of heart disease, more information is needed about its effects on coronary atherosclerosis and the extent to which concomitant progestin therapy may modify these effects. Methods: The investigators randomly assigned a total of 309 women with angiographically verified coronary disease to receive 0.625 mg of conjugated estrogen per day, 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate per day, or placebo. The women were followed for a mean (±SD) of 3.2±0.6 years. Base-line and follow-up coronary angiograms were were analyzed by quantitative methods. Follow-up coronary angiograms were obtained after an average of 3.2 years of follow up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
309
one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily
one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily
two placebo tablets daily
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
mean minimal coronary-artery diameter
mean minimal coronary-artery diameter within each subject at follow-up, analyzed on an intention-to-treat basis
Time frame: at average of 3.2 years follow-up
stenosis as a percentage of the reference diameter
Time frame: at average of 3.2 years follow-up
development of new lesions in a patient
Time frame: at average of 3.2 years follow-up
Models focusing on change in diameter were also examined
Time frame: at average of 3.2 years follow-up
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