| Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms | | Print | |
| Monday, 27 July 2009 15:59 |
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The data, published online July 27, 2009 in the peer-reviewed journal Fertility and Sterility, is from the Selective estrogens Menopause And Response to Therapy (SMART-1) clinical trial. SMART-1 was designed to explore the hypothesis that bazedoxifene, when paired with conjugated estrogens, may have the potential to eliminate the need for progestin in menopausal therapy in women with an intact uterus. BZA/CE is characterized by Wyeth as a TSEC (tissue selective estrogen complex) as it combines a selective estrogen receptor modulator (SERM) with conjugated estrogens. Across the SMART-1 trial, the incidence of treatment-emergent adverse events, breast pain, serious adverse events and withdrawals due to adverse events were similar among the active treatment groups and placebo. About SMART-1 SMART-1 was a two-year, multinational, multicenter, randomized, double-blind, placebo- and active-controlled Phase 3 study that evaluated 3,397 healthy, postmenopausal women with an intact uterus aged 40 to 75 years. The primary end point of the SMART-1 trial was incidence of endometrial hyperplasia at one year. Secondary end points included bone mineral density (BMD) at two years, menopausal vasomotor symptoms at four and 12 weeks, vaginal maturation index at six months, menopause-related quality of life measures, and overall safety and tolerability. The results were published concurrently across four manuscripts at http://www.fertstert.org/inpress. Titles and Summary of Findings From Published Manuscripts 1. Endometrial Protection in Menopausal Therapy with a Tissue Selective Estrogen Complex (TSEC) Containing Bazedoxifene/Conjugated Estrogens (Pickar JH, et al) To evaluate endometrial effects, biopsies were performed at screening and at months six, 12, and 24, or when subjects withdrew from the study and more than three months had elapsed since their last assessment. Treatment with BZA/CE doses being considered for therapeutic use were associated with rates of endometrial hyperplasia <1%. These rates were not significantly different from those reported with placebo over two years of study. 2. Bazedoxifene/Conjugated Estrogens (BZA/CE): Incidence of Uterine Bleeding in Postmenopausal Women (Archer DF, et al) To evaluate the effect of treatment with BZA/CE on uterine bleeding, trial participants were asked to record in a diary whether or not they experienced bleeding and/or spotting. The mean number of bleeding or spotting days with BZA/CE was not statistically different from placebo over two years of therapy. 3. Evaluation of Bazedoxifene/Conjugated Estrogens (BZA/CE) for the Treatment of Menopausal Symptoms and Effects on Metabolic Parameters and Overall Safety Profile (Lobo R, et al) Results from a sub-analysis suggest that treatment with BZA/CE significantly reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy compared with placebo. In this study, analysis of most clinical laboratory determinations revealed no clinically important differences among treatment groups and no trends of concern. The incidences of breast pain and adverse events were similar between BZA/CE and placebo. 4. Efficacy of Tissue-Selective Estrogen Complex (TSEC) of Bazedoxifene/Conjugated Estrogens (BZA/CE) for Osteoporosis Prevention in At-Risk Postmenopausal Women (Lindsay R, et al) When compared with placebo, treatment with BZA/CE increased BMD at the lumbar spine and total hip at 24 months. These results suggest that women in the BZA/CE groups gained bone mass while women in the placebo treatment group lost BMD. About Menopause Approximately 40 million women in the United States are of menopausal age (45 to 64 years). Of these women, 17 million experience vasomotor symptoms; 9 million experience moderate to severe symptoms. Menopause is different for every woman, and vasomotor symptoms can last from a few months to many years and they can be mild, moderate or severe enough to interfere with daily life. The majority of menopausal women experiencing moderate to severe vasomotor symptoms are not currently treating their symptoms. About Fertility and Sterility Fertility and Sterility is the official publication of the American Society of Reproductive Medicine, which publishes peer-reviewed original articles of research relevant to reproductive endocrinology, physiology, immunology, genetics and menopause. About Wyeth Pharmaceuticals Wyeth Pharmaceuticals has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section Add this page to your favorite Social Bookmarking websites           
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COLLEGEVILLE, Pa.-- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: 
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