- The Washington Times - Tuesday, March 2, 2004

A clinical trial of hormone therapy for women was halted because preliminary data showed that estrogen raises the risk of strokes, the National Institutes of Health (NIH) announced yesterday.

The 11,000 participants in the Women’s Health Initiative Estrogen-Alone study have been asked to stop taking the pills and to begin the follow-up phase. The full results are expected to be reported in the next two months.

“Estrogen alone does not appear to [either increase or decrease] heart disease, a key question of the study,” said Dr. Barbara Alving, director of the Women’s Health Initiative. “At the same time, estrogen alone appears to increase the risk of stroke and decrease the risk of hip fracture.”

The study of estrogen-replacement therapy involved healthy women who were 50 to 79 years old and had undergone hysterectomies. It was aimed at assessing the effects of long-term use of hormone therapy on the prevention of heart disease and hip fractures.

For seven years on average, 11,000 women had been randomly assigned to a daily dose of Wyeth Co.’s Premarin estrogen-only pill or a placebo.

“The increased risk of stroke in the estrogen-alone study is similar to what was found in the Women’s Health Initiative study of estrogen plus progestin when that trial was stopped in July 2002,” said Dr. Alving, also acting director of the National Heart, Lung and Blood Institute, which organized the test.

An earlier estrogen-progestin trial, stopped after more than five years, found eight more strokes per year among every 10,000 women taking the therapy than among those taking the placebo.

“An increased risk of stroke is not acceptable in healthy women in a research study. This is especially true if estrogen alone does not affect heart disease, as appears to be the case in the current study,” NIH reported.

Researchers found no increased risk of breast cancer during the estrogen-alone study.

The final results of the study also will address any influence of estrogen therapy on the memories of women 65 and older.

“Preliminary data suggests that … there was a trend toward increased risk of probable dementia and/or mild cognitive impairments,” Dr. Alving said.

Immediately after NIH announced it was halting the estrogen trial, the Food and Drug Administration (FDA) said it would determine whether the new data required additional labeling changes for hormones used in such therapy.

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