A recent analysis of tamoxifen studies completed since 1980 revealed an increased risk of stroke in women who were randomized to tamoxifen versus placebo or other therapies. Details of the analysis and the researchers' conclusions are reported in the October 12 issue of Neurology, the scientific journal of the American Academy of Neurology.
More than 250,000 U.S. women are diagnosed with breast cancer each year. Breast cancer accounts for nearly one in three cancers diagnosed in the U.S. and is the second leading cause of death for women. Fortunately, 90 percent of breast cancers are now diagnosed at localized and regional stages, for which five-year survival rates are 97 percent and 79 percent, respectively. Tamoxifen, a medication in pill form that interferes with the activity of estrogen, has been used for more than 20 years to treat patients with advanced breast cancer. It is used as adjuvant, or additional, therapy following primary treatment for early stage breast cancer. In women at high risk of developing breast cancer, tamoxifen reduces the chance of developing the disease.
In addition to its effects on breast cancer, the benefits of tamoxifen include increased bone mineral density, reduced risk of hip fractures, and lower levels of cholesterol. While tamoxifen is known to increase the risk of blood clotting in women with cancer, its relationship to stroke risk has been unclear. Because tamoxifen increases the risk of thromboembolism (a blood clot that has traveled from its site of origin to another vessel), its use could be associated with a higher risk of ischemic stroke (arterial obstruction) as compared to hemorrhagic (bleeding) stroke.
Researchers from Duke University Medical Center sought to determine the overall risk of both ischemic stroke and all strokes associated with tamoxifen. They conducted a systematic review of all clinical trials of tamoxifen published since 1980 using MEDLINE.
Nine 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).