Wyeth Pharmaceuticals has announced that data from Phase III clinical studies involving the investigational compound bazedoxifene/conjugated estrogens (BZA/CE) have shown significant benefits against the symptoms of menopause.
The results of the study showed that BZA/CE significantly reduced the frequency and severity of hot flushes and improved measures of vaginal atrophy when compared to placebo.
BZA/CE is being studied by Wyeth Pharmaceuticals, a division of Wyeth, for the treatment of moderate-to-severe menopausal vasomotor symptoms such as hot flushes, night sweats and vulvar and vaginal atrophy, and for the prevention of postmenopausal osteoporosis.
The SMART-1 trial was designed to explore whether 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.
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.
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.
Furthermore, when compared with placebo, treatment with BZA/CE increased BMD at the lumbar spine and 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.
The mean number of bleeding or spotting days with BZA/CE was not statistically different from placebo over two years of therapy.