Cardiovascular Diseases Clinical Trial
To evaluate the cardiovascular effects of postmenopausal hormone replacement therapy and the suspected beneficial effects on myocardial infarction and stroke.
BACKGROUND:
Post-menopausal women who use estrogens generally experience at once a reduced risk of
coronary heart disease and, at the same time, an increased risk of endometrial cancer. In
order to protect the endometrium from unopposed estrogens, many physicians now recommend the
addition of a progestin during 10-13 days of the cycle. Progestins may be implicated in the
increased risk of myocardial infarction in women on oral contraceptives.
DESIGN NARRATIVE:
This was a case-control study. The computerized files of the Group Health Cooperative (GHC)
in Seattle were used to identify cases. All postmenopausal women, aged 40 to 79, were
eligible as cases if, according to World Health Organization criteria, they presented with a
fatal or non-fatal myocardial infarction. A random sample of women listed in the enrollment
files at GHC served as a source of potential controls. Review of the out-patient medical
records, performed by an assistant blind to case-control status ensured that all study
subjects met the same criteria. Telephone interviews were used to obtain information about
exposure to postmenopausal hormones as well as known risk factors. The computerized pharmacy
records at GHC provided additional information about exposure. Frequency matching controlled
for the potential confounding effects of age and year of presentation. Stratification and
logistic regression were used in data analysis.
The study was renewed in 1995 to make more precise some of the indeterminate findings
related to current use, cumulative dose and duration of use but also to extend the
assessment of the risk or benefit to incident strokes. The study ended in January, 1999.
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