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NIH stops estrogen-only arm of Women's Health Initiative trial
  By Maggie Fox
WASHINGTON (Reuters) - The National Institutes of Health said on Tuesday it had stopped a large trial of women taking estrogen replacement therapy, after finding it not only failed to improve their health but also may have slightly raised the risk of strokes.
In July 2002, the arm of the Women's Health Initiative in which women were taking estrogen plus progestin was stopped abruptly because of the risk of heart attack, stroke and some forms of cancer.
The 11,000 women in the estrogen-only part of the trial that was stopped on Tuesday were taking Wyeth Co.'s Premarin.
"After careful consideration of the data, NIH has concluded that with an average of nearly seven years of follow-up completed, estrogen alone does not appear to affect (either increase or decrease) heart disease, a key question of the study," the National Heart, Lung and Blood Institute, which runs the Women's Health Initiative, said in a statement.
"At the same time, estrogen alone appears to increase the risk of stroke and decrease the risk of hip fracture. It has not increased the risk of breast cancer during the time period of the study."
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," the NHLBI said.
"In that study, women taking estrogen plus progestin had eight more strokes per year for every 10,000 women than those taking the placebo. The NIH believes that an increased risk of stroke is not acceptable in healthy women in a research study."
But officials stressed that women taking ERT should not panic, because the risk of stroke had already been noted years before. "This is not an emergency," Dr. Barbara Alving, director of the Women's Health Initiative trial, told reporters.
The women had received letters in 2000 and 2002 warning them of the stroke risk. The NIH decided to stop the trial about a year early after getting enough information to decide that the benefits of estrogen did not outweigh the stroke risk.
Some advisers disagreed, but the decision was finally made "at the top level" of the NIH to stop the trial and analyze the data. Details on the effects of estrogen-only therapy will be published in a major medical journal in April, Dr. Alving said.
She said the findings would not apply to young women who take estrogen after having hysterectomies. "The mean age of these women is about 70 years of age. We are talking about women of a certain age, a certain population," she said.
The Food and Drug Administration, which has been directing hormone replacement therapy makers to update their labeling with clear warnings, said it will act on the latest findings.
"FDA is advising women that postmenopausal hormone therapy has never received approval for prevention of heart disease, or cognitive disorders such as Alzheimer's disease or memory loss," the agency said in a statement.
"FDA emphasizes that when estrogen-containing products are used for relief of postmenopausal symptoms such as hot flushes, they should be used only when the symptoms are moderate to severe. When used for treating moderate to severe symptoms of vulvar and vaginal atrophy, FDA urges healthcare providers to consider the use of topical products first," the FDA added.
"In addition, when estrogen-containing products are prescribed only to treat postmenopausal osteoporosis, FDA recommends that they be considered only for women at significant risk for osteoporosis and for whom non-estrogen treatments are inappropriate."


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