[Bazedoxifene as a new-generation SERM]

Bazedoxifene is a new-generation SERM with a novel chemical structure, which has been developed to provide improved efficacy on the bone and the lipid profile, as well as improved safety for breast and endometrial tissues. A statistically significant 42% reduction in the incidence of new vertebral fractures has been reported with bazedoxifene treatment in an overseas phase III trial, equal to that reported with the bisphosphonates and raloxifene. A significant reduction in the incidence of non-vertebral fractures was also shown with bazedoxifene, compared to placebo and raloxifene in the high-risk population in a post-hoc analysis. These data suggest that bazedoxifene could be more effective in reducing the risk for non-vertebral fractures than raloxifene. Bazedoxifene has demonstrated a favorable safety and tolerability profile with no significant differences observed among the treatment groups in coronary artery events, cerebrovascular events, and overall death rates. The incidence of adverse events, such as VTEs, hot flushes and leg cramps, reported as a class effect of the SERMs, were higher with bazedoxifene than with placebo, but was similar to that with raloxifene. Bazedoxifene is thus expected to become an important new option for the treatment of postmenopausal osteoporosis in Japan.