Separate Retrospective Analysis of Phase 3 Data Offers Additional Information on Bazedoxifene Alone
COLLEGEVILLE, Pa., Sept. 25 /PRNewswire/ -- A retrospective analysis of Phase 3 two-year data presented at the annual meeting of the North American Menopause Society (NAMS) suggest that postmenopausal women treated with bazedoxifene/conjugated estrogens (BZA/CE) may experience incidence of breast tenderness and abnormal mammograms no greater than those treated with placebo. BZA/CE is an investigational compound being studied by Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flashes and night sweats, and for the prevention of postmenopausal osteoporosis. Wyeth describes this compound as a tissue selective estrogen complex (TSEC).
In a retrospective analysis of data from another phase 3 study, treatment with Wyeth's investigational compound bazedoxifene (BZA) alone did not appear to increase mammographic breast density in postmenopausal women with osteoporosis compared to raloxifene (the active comparator) or placebo over two years. BZA is an investigational selective estrogen receptor modulator (SERM) under development for the treatment and prevention of postmenopausal osteoporosis.
NAMS Poster Titled: Breast Effects of Bazedoxifene/Conjugated Estrogens in a Randomized, Controlled Trial of Postmenopausal Women
In the phase 3 study involving 3,397 postmenopausal women, primarily
designed to evaluate the effects of BZA/CE on the endometrium and bone
mineral density, mammograms were taken at baseline, and again at years one
and two as part of the safety evaluation. Breast tenderness was reported in
|SOURCE Wyeth Pharmaceuticals|
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