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Analysis of tamoxifen studies reveals slight increase of stroke risk

trials met their inclusion criteria, with 39,601 total subjects enrolled, 19,954 of whom were randomized to tamoxifen. Six of the trials specifically reported ischemic stroke events. All trials used a standard dose of tamoxifen (20 mg daily).

"With tamoxifen, we found the frequency of all strokes was 1.06 percent and for ischemic stroke was 0.71 percent, versus 0.39 percent with controls," reported study author Cheryl Bushnell, MD, MHS. The risk of ischemic stroke increased by 82 percent and risk of all strokes by 29 percent in women randomized to tamoxifen versus placebo or other therapies. Bushnell concluded, "The absolute increase in risk was small."

"The results of this analysis support the practice of careful screening of women who are being considered for tamoxifen therapy," noted Bushnell, "although physicians and their patients should be reassured that the absolute risk of stroke may be very low. In many women, this risk of stroke with tamoxifen may be outweighed by the benefit of treating or preventing breast cancer. In addition, women should not stop their prescribed therapy based on this study."

Results of this analysis should be interpreted with some caution. Among other variables, specific stroke risk factors of the women in these studies were not reported, and the methods of determining ischemic or other types of stroke were not documented in any of the trials. Ongoing studies of tamoxifen that are designed to carefully track stroke events will further clarify this risk.


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Contact: Marilee Reu
mreu@aan.com
651-695-2789
American Academy of Neurology
11-Oct-2004


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