Bazedoxifene/conjugated estrogens: Phase III data

The double-blind, international Phase III SMART-5 trial in 1,843 non-hysterectomized, postmenopausal women showed that once-daily low- and high-dose oral bazedoxifene/conjugated estrogens (BZA/CE) (20 mg/0.45 mg and 20 mg/0.625 mg) led to 1-year rates of endometrial hyperplasia, a co-primary endpoint, that were similar to placebo (0.3% and 0.27%, respectively, vs. 0.28%). The incidence of endometrial hyperplasia for the active-controls bazedoxifene monotherapy and Prempro medroxyprogesterone was 0% and 0%, respectively. Pfizer also said that both doses of BZA/CE prevented postmenopausal osteoporosis, the other co-primary endpoint, vs. placebo at 1 year.

Additionally, in a subset of 940 women enrolled in a breast density sub-study, there was no significant difference between either dose of BZA/CE and placebo in breast density at 1 year. Prempro did significantly increase mean percent breast density vs. placebo at 1 year (p<0.001). In a subset of 459 women with bothersome vasomotor symptoms and sleep problems at baseline, high-dose BZA/CE significantly improved mean scores for sleep adequacy, sleep disturbance, sleep problems overall and time to fall asleep from baseline to 1 year vs. placebo (p<0.05 for all), while low-dose BZA/CE significantly improved mean scores for sleep disturbance and time to fall asleep (p<0.05 for both). ...