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Estrogen hormone replacement therapy does not reduce the risk of stroke or death in postmenopausal women who have already had a stroke or a transient ischemic attack.
Estrogen hormone replacement therapy does not reduce the risk of stroke or death in postmenopausal women who have already had a stroke or a transient ischemic attack, according to a report from the first randomized, controlled clinical trial of estrogen therapy for secondary prevention of cerebrovascular disease.
Previous observational studies have suggested that estrogen replacement therapy may reduce the risk of stroke and death in postmenopausal women. However, it was not clear whether the apparent benefits of estrogen among women in those studies were due to the hormone therapy or other factors. The new, randomized, double-blind, placebo-controlled study, called the Women's Estrogen for Stroke Trial, was designed to resolve this question. The study, led by Ralph I. Horwitz, M.D., of the Yale University School of Medicine, was funded by the National Institute of Neurological Disorders and Stroke and was published in The New England Journal of Medicine (vol. 345, no. 17).
"The good news is that we have taken a lot of guesswork out of treating women with strokes. The benefits from estrogen that we hoped for are not there to balance the risks," said John R. Marler, NINDS associate director for clinical trials.
Based on this finding, the investigators say, estrogen therapy should not be prescribed for the purpose of preventing a second stroke or death in postmenopausal women.
The researchers enrolled 664 postmenopausal women with an average age of 71 years who had experienced an ischemic stroke or a TIA within the previous 90 days. In addition to the usual care for patients who have had a stroke, women in the trial received either oral estrogen or a matching placebo. Patients were studied for an average of 2.8 years. They stopped receiving the estrogen or placebo if they had a stroke.
The researchers found no significant difference in the incidence of stroke or death in the women who were randomly assigned to receive estrogen instead of placebo. However, the incidence of death due to stroke was higher in the estrogen group and that the non-fatal strokes in that group were associated with slightly worse neurological and functional impairments at one month after stroke. The risk of stroke within the first six months after enrollment in the study was also higher among women in the estrogen group. There were no significant differences between treatment groups in the number of TIAs or non-fatal heart attacks.
While the WEST study provides important information about the use of estrogen in women with existing cerebrovascular disease, many questions remain to be answered, according to the investigators. They are planning additional analyses of their data to look at the effects of estrogen on cognition and physical function, said Horwitz. PR