Retrospective Analysis of Phase 3 Data Suggest Wyeth's Investigational Compound Bazedoxifene/Conjugated Estrogens Comparable to Placebo on Incidence of Abnormal ... (iaries. A retrospective analysis suggest...)

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Retrospective Analysis of Phase 3 Data Suggest Wyeth's Investigational Compound Bazedoxifene/Conjugated Estrogens Comparable to Placebo on Incidence of Abnormal Mammograms

Date:9/25/2008

iaries. A retrospective analysis suggested no significant differences in the incidence of breast tenderness or abnormal mammograms between the BZA/CE groups at any of the doses studied and placebo or raloxifene.

In this study, the incidence of treatment-emergent adverse events, serious adverse events, and withdrawals due to adverse events were similar among the active treatment groups and placebo.

NAMS Poster Titled: Effects of Bazedoxifene on Mammographic Breast Density in Postmenopausal Women with Osteoporosis

A retrospective study examined mammograms in a subset representing 726 postmenopausal women from a primary phase 3 fracture reduction study of BZA, raloxifene, and placebo. The objective was to evaluate the quantitative changes in mammographic breast density after 24 months of treatment. This study indicated treatment with BZA over 24 months did not affect mammographic breast density in postmenopausal women with osteoporosis. Changes in breast density with BZA were similar to those with raloxifene and placebo.

Also presented at the NAMS meeting were data on the effects of BZA/CE on sleep and overall menopausal symptoms.

About TSEC

Wyeth describes the pairing of a selective estrogen receptor modulator (SERM) and one or more estrogens as a TSEC. The TSEC concept is based on the blended tissue-selective activity of the components, which is hypothesized to yield different clinical results than those provided by either the SERM or estrogen(s) alone.

About Menopause

According to the U.S. Census Bureau, in 2006, there were approximately 20 million women of menopausal age (45-54 years) in the United States. As many as 50 percent to 90 percent of women going through menopause experience vasomotor symptoms, such as hot flashes, which can greatly impact a woman's life. Furthermore, between 10 percent and 40 percent of postmenopausal women experience symptoms of vulvar and vaginal atrophy, which typically do not su
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Retrospective Analysis of Phase 3 Data Suggest Wyeth's Investigational Compound Bazedoxifene/Conjugated Estrogens Comparable to Placebo on Incidence of Abnormal ...(iaries. A retrospective analysis suggest...)