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Raloxifene Shown to Reduce Anxiety in Post-Menopausal Women (dateline September 10, 2000)

In addition to helping prevent bone loss and possibly reducing the risk of breast cancer in women at high risk for the disease, researchers have found that the drug raloxifene (brand name, Evista) may also help relieve anxiety levels in post-menopausal women. According to the researchers, approximately 50% of the women in the study who had taken raloxifene for one year said the drug eased their anxiety.

Raloxifene is approved by the U.S. Food and Drug Administration (FDA) to help prevent and treat osteoporosis in post-menopausal women. Osteoporosis is a degenerative bone disease that affects roughly one third of women over age 50. Raloxifene mimics the effects of the female hormone, estrogen, and helps reduce bone loss while increasing bone density. In several studies, raloxifene has reduced fracture risk by 50%.

According to lead researcher Dr. Ronald Strickler of the Henry Ford Hospital in Detroit, Michigan, finding that raloxifene helped relieve anxiety was a surprise. In the study, other quality of life factors such as depressed mood, memory/concentration sexual behavior, sleep problems, etc. were unchanged among women on raloxifene. Women who took estrogen replacement therapy in the study experienced a decrease in hot flashes, while women on raloxifene experience no change in hot flashes.

In addition to helping prevent and treat osteoporosis, raloxifene is being tested in clinical trials to determine if it can safely and effectively prevent breast cancer in high risk women. Raloxifene, which is similar to the breast cancer drug tamoxifen  (brand name, Nolvadex), is thought to compete with estrogen to bind to estrogen receptors in breast cancer cells. By blocking estrogen in the breast, raloxifene slows the growth and reproduction of breast cancer cells.

The STAR trial (Study of Tamoxifen and Raloxifene) will help determine the long-term safety of raloxifene and tamoxifen in helping to prevent breast cancer in 22,000 post-menopausal women over age 35. While tamoxifen has been shown to significantly reduce the chances of invasive breast cancer in women at high risk, it can increase the chances of endometrial cancer (cancer of the lining of the uterus).

In osteoporosis studies, raloxifene did not increase the risk of endometrial cancer. An important part of STAR will be to compare the long-term safety of raloxifene and tamoxifen in women at increased risk for breast cancer. Though the STAR trial began in May 1999, researchers are still enrolling participants across the United States. To date, over 6,000 women have been enrolled in the STAR trial and researchers are hoping that another 16,000 women will join within the next few years.

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