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New Hormone Therapy Shows Promise for Menopausal Symptoms

Novel approach combines estrogen with SERM-like drug (Dec. 13)

Researchers at Wake Forest Baptist Medical Center in Winston-Salem, N.C., have concluded research on a new postmenopausal hormone therapy that shows promise as an effective treatment for menopausal symptoms and for the prevention of osteoporosis without increasing the risk for heart disease or breast cancer.

According to co-author J. Mark Cline, DVM, PhD, traditional forms of hormone therapy (HT) provide the benefits of symptom relief and prevention of osteoporosis and atherosclerosis, but increase the risk of uterine cancer (with estrogens alone) or breast cancer (with combined estrogens and progestins). Therefore, the risk-benefit ratio of traditional HT is not ideal. On the other hand, less potent plant-derived estrogens are relatively safe, but less effective. Selective estrogen receptor modulators (SERMs) provide both beneficial effects and adverse effects, but the ideal menopause treatment remains elusive.

The researchers therefore explored a new treatment strategy, called Tissue-Selective Estrogen Combination (TSEC), in an animal model. Using this approach, a conventional estrogen was combined with a bone-protective SERM-like drug, bazedoxifene acetate, to produce a complementary pattern of tissue effects that maximize the benefits of HT while avoiding the risk. A 20-month randomized, parallel-arm trial was conducted in postmenopausal nonhuman primates to determine the effect of TSEC treatment on the breast, uterus, and cardiovascular system. The TSEC strategy has also been evaluated in the SMART (Selective Estrogens, Menopause, And Response to Therapy) phase III trials involving more than 6,000 women.

Cline said nonhuman primate trials are important because they can address tissue responses directly, whereas studies in women use clinical outcomes that may require many years to provide conclusive results.

The new research was published in Menopause, the journal of the North American Menopause Society.

Source: Wake Forest Baptist Medical Center; December 13, 2012.

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