Hypertension Clinical Trial
To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
BACKGROUND:
The life expectancy of American women is 78 years. More than one-third of those years are
postmenopausal, during which time the risk of coronary heart disease is increased. The
current United States estimate of more than 40 million women over the age of 50 indicates a
large segment of the population at increased risk for coronary heart disease. Heart disease
accounts for a third of all deaths in 50-69 year old women. In 1978, for example,
approximately 66,000 of the 210,000 deaths in women 50-69 were attributed to heart disease.
Premenopausal women have a lower rate of ischemic heart disease compared to men of similar
age. Surgically induced or natural early menopause increases the risk of ischemic heart
disease. These facts have focused interest on estrogens as possible mediators of the
beneficial effects, and pointed to the need for further study of their relationship to
atherosclerosis risk factors.
Estimates from the Lipid Research Clinics Program indicate estrogen use in approximately one
third of postmenopausal women. Analysis of Lipid Research Clinics data confirmed that
administration of estrogens results in lower plasma low density lipoprotein levels and
elevated plasma high density lipoprotein levels. Thus, the ratio of high density
lipoprotein/low density lipoprotein levels is substantially increased. Given the inverse
relationship between high density lipoprotein levels and coronary heart disease risk, this
effect of estrogens on the plasma lipoproteins could be expected to further reduce coronary
heart disease risk in women.
Although the bulk of currently available evidence suggests benefit, some controversy
concerning the effects of postmenopausal estrogens on morbidity and mortality from coronary
heart disease persists. Analysis of the Lipid Research Clinics Follow-up Study population
indicated a potentially profound beneficial effect of postmenopausal estrogen use. Mortality
from all causes decreased considerably in postmenopausal estrogen users, and the effect was
most pronounced in hysterectomized and oophorectomized women. Similar results have been
observed for cardiovascular deaths. These benefits appeared to be mediated by the higher
high density lipoprotein levels associated with postmenopausal estrogen use. Framingham data
are the primary sources reporting possible detrimental effects of postmenopausal estrogen
use on cardiovascular morbidity; mortality from all cause and cardiovascular disease was not
reported to vary by use.
NHLBI convened a Trans-NIH Estrogen Working Group to make recommendations to NHLBI on the
feasibility of undertaking a clinical trial of the effects of postmenopausal estrogen use on
cardiovascular disease mortality. The Working Group identified a number of important
research questions which needed to be answered to elucidate the effects of postmenopausal
estrogen use on risk factors for cardiovascular disease and osteoporosis. This initiative
was the result of the Working Group's deliberations and recommendations.
DESIGN NARRATIVE:
There were seven clinical centers and a coordinating center in this randomized, double-blind
clinical trial. The women were allocated to one of five treatment arms: placebo; conjugated
equine estrogen (CEE), 0.625 milligrams per day; conjugated equine estrogen, 0.625
milligrams per day plus cyclic medroxyprogesterone acetate (MPA), 10 milligrams per day for
12 days per month; CEE, 0.625 milligrams per day plus consecutive MPA, 2.5 milligrams per
day; CEE, 0.625 milligrams per day plus cyclic micronized progesterone (MP), 200 milligrams
per day for 12 days a month. The four primary endpoints were chosen to represent four
biological systems related to the risk of cardiovascular disease and included high density
lipoprotein cholesterol (HDL-C), systolic blood pressure, serum insulin, and fibrinogen.
Recruitment began in October 1989 and ended in February 1991. Baseline data collected
included blood pressure, resting heart rate, weight, waist/hip ratios and endometrial
biopsy. Laboratory evaluations included lipid panel, high density lipoprotein cholesterol,
insulin and glucose, bone density, fibrinogen, and in three clinics, additional hemostasis
factors, renin substrate, plasma renin activity, aldosterone, and oral post-heparin lipase
activity. All women underwent an endometrial aspiration biopsy at baseline and annually
thereafter. Additional biopsy specimens were obtained if there was noncyclic endometrial
bleeding. All women also had baseline and annual mammograms. Other data were collected on
quality of life, exercise, diet, alcohol use, and smoking. Participants were followed at
three, six and twelve months post-randomization, and at six month intervals thereafter for
three years. Post-trial analyses of existing data sets were funded for three years by the
cooperative agreement mechanism beginning August 1, 1994. A three-year safety follow-up
funded through the contract mechanism began in 1994. It included three annual visits at
which endometrial biopsies, mammograms, and some limited health information were obtained.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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