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PEPI - First results on heart disease risk factors
A huge amount of information was collected in PEPI. Thus, the results will take time to be fully analyzed. But, because of their importance to women and their doctors, the findings are being released, as they become available. The first results are summarized here--they are reported in detail in the January 18, 1995 issue of the Journal of the American Medical Association, in the article titled "Effects of Estrogen or Estrogen/Progestin Regimens on Heart Disease Risk Factors in Postmenopausal Women" (volume 273, pages199-208).

The first results cover PEPI's findings on changes in heart disease risk factors and on hormone safety. For heart disease risk factors, key results are:

  • Estrogen-only therapy raises the level of good HDL cholesterol. (This finding had been previously reported in short-term studies and can now be expanded to long-term effects.)
  • The combined estrogen-progestin therapies also increased HDL levels, although less than estrogen alone. At the same time, the addition of progestin produced the desired effect of reducing the increased risk of overgrowth of the lining of the uterus (endometrial hyperplasia) associated with estrogen-only therapy. The natural micronized progesterone produced a higher HDL level than the synthetic form.
  • All of the hormone regimens decreased the level of "bad" LDL cholesterol about equally well.
  • Blood pressure was not increased by any of the hormone regimens.
  • Fibrinogen levels were decreased by all of the hormones, which is thought to be a desirable change. Fibrinogen allows clots to form more readily, which increases the risk of heart disease and stroke.
  • Insulin levels were not significantly affected by any of the hormone regimens. While fasting blood glucose seemed to be reduced by all of the regimens, the blood glucose 2 hours after eating seemed to be elevated to varying degrees. The importance of these changes is unclear, but they are of interest because of their relationship to carbohydrate metabolism and potentially to diabetes, which would in turn affect the risk of heart disease. These altered glucose levels need further evaluation.
  • All hormone regimens caused a rise in triglyceride levels. These are fatty substances carried through the blood to tissues, where they are stored for use as energy. Their link to heart disease risk is not clear.
  • None of the hormone regimens caused a significant weight gain.

For hormone safety, a key result is - women with a uterus who took only estrogen had a higher risk of changes to the uterus lining. A third of these women developed serious abnormal cell growth of the endometrium. These hyperplasias can become cancerous but, if caught early, are treatable. PEPI did not last long enough to study the effect of hormone therapy on the risk of breast cancer.

Source: The National Heart, Lung and Blood Institute





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