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Heart Health

PEPI - the study

To learn more about estrogen's possible benefits and risks, the National Heart, Lung, and Blood Institute (NHLBI) and other units of the National Institutes of Health started a major clinical trial in 1987--the "Postmenopausal Estrogen/Progestin Interventions Trial," called PEPI. PEPI's other sponsors are 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.

PEPI was conducted at seven clinical centers across the United States. It followed 875 women, ages 45-64, for 3years. All were healthy and postmenopausal, and about a third had had a hysterectomy. Participants included a variety of races but were predominantly white. The women were closely monitored and had such tests as a yearly physical examination, mammogram, and, for those with a uterus, endometrial biopsy. The main goal was to see what effects different hormone regimens would have on some key risk factors for heart disease.

The study also collected other information, including the regimens' effects on quality of life, bone mass, and the risk of endometrial changes that might progress into cancer.

The four hormone regimens tested were:

Estrogen alone, taken daily
Estrogen taken daily and a synthetic progestin (medroxyprogesterone acetate), taken 12 days a month
Estrogen and synthetic progestin taken daily
Estrogen taken daily plus a natural progesterone (micronized progesterone), taken 12 days a month.

The effects of these regimens were compared with those of a placebo, a substance that looks like the real drug but has no biologic effect. The trial also compared for the first time the effects of cyclic and continuous use of progestin. Cyclic use mean staking a medication for only some days of each month, while continuous use means taking the drug daily throughout the month. A main reason for the comparison was to see if continuous use produced less bleeding.

Source: The National Heart, Lung and Blood Institute