MEDICATIONS: NEW FACTS ABOUT ESTROGEN/PROGESTIN HORMONE THERAPY

MEDICATIONS: NEW FACTS ABOUT ESTROGEN/PROGESTIN HORMONE THERAPY

Choosing whether or not to use post-menopausal hormone therapy is one of the most important health decisions women face as they age. On July 9, 2002, new findings were released about the type of postmenopausal hormone therapy that uses estrogen plus progestin. The findings offer women important new guidance in considering this type of postmenopausal hormone therapy.

The findings come from the Women's Health Initiative (WHI), a 15-year study of ways to prevent heart disease, breast and colorectal cancer, and osteoporosis. WHI, which consists of a set of clinical studies and an observational study, began in 1991 and involves more than 161,000 healthy postmenopausal women. WHI is sponsored by the National Heart, Lung and Blood Institute (NHLBI) in collaboration with other units of the National Institutes of Health.

One of the clinical studies involved 16,608 women with a uterus who took either estrogen plus progestin therapy or a placebo (a substance that looks like the real drug but has no biologic effect). The main goal was to see if the therapy would help prevent heart disease and hip fractures. Another goal was to see if those possible benefits were greater than the possible risks for breast cancer, endometrial cancer and blood clots.

The study was stopped early because after 5.2 years the therapy's risks outweighed and outnumbered its benefits.

Another WHI study seeks to answer the same questions for estrogen-only therapy and continues, with results expected in 2005.

Understanding the Results

Results from the estrogen plus progestin study are given in the box. They show that the therapy did not protect against heart disease but actually increased heart attacks, stroke and blood clots. It also increased the chance of breast cancer. It produced some benefits too: It reduced the risk of colorectal cancer and bone fractures.

It's important to understand that these increased risks apply to an entire population. Women should not be unduly alarmed by the results. The increased risk for an individual woman would be small. For instance, each woman in the study who took the estrogen plus progestin therapy had an increased risk of breast cancer of less than a tenth of 1 percent per year.

Study Results

· Estrogen/progestin therapy resulted in a 26 percent increase in breast cancer, which caused the study to be stopped. No increase in deaths from breast cancer occurred from the combined therapy — or in deaths from other causes.

Estrogen/progestin therapy also resulted in:

· 41 percent increase in strokes

· 29 percent increase in heart attacks

· Doubled rates of blood clots in legs and lungs

· 37 percent less colorectal cancer

· 34 percnet fewer hip fractures and 24 percent less total fractures

Recommendations

The new findings allow the following recommendations for estrogen plus progestin use:

1. The therapy should not be continued or started to prevent heart disease. Women should consult their doctor about other methods of prevention, such as lifestyle changes, and cholesterol- and blood pressure-lowering drugs.

2. For osteoporosis prevention, women should consult their doctor and weigh the benefits against their personal risks for heart attack, stroke, blood clots and breast cancer. Alternate treatments also are available to prevent osteoporosis and fractures.

3. Women should keep up with their regular schedule of mammograms and breast self-examinations.

Finally, while short-term use was not studied, women taking the therapy for relief of menopausal symptoms may reap more benefits than risks. Women should talk with their doctor about their personal risks and benefits.

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