Raloxifene

Status

FDA-approved. FDA-approved labeling exists as Evista for treatment and prevention of osteoporosis in postmenopausal women and for risk reduction of invasive breast cancer in defined high-risk groups. It carries a boxed warning for venous thromboembolism and death from stroke.

What it is

A SERM approved for osteoporosis in postmenopausal women.

What published research measured

A selective oestrogen receptor modulator that is oestrogenic in bone and anti-oestrogenic in breast and endometrium — the last distinguishing it from tamoxifen, since it does not carry the same endometrial cancer risk. The MORE and CORE trials established reductions in vertebral fracture and in invasive breast cancer incidence in postmenopausal women, and the RUTH trial examined cardiovascular outcomes. Notably, it reduces vertebral fractures without a demonstrated reduction in hip fractures. Venous thromboembolism risk is increased, and the RUTH trial found increased fatal stroke in women at cardiovascular risk. It does not treat vasomotor symptoms and can worsen them.

Source

MORE and CORE trials · RUTH trial · FDA labeling for Evista

Sources

• Half-life source for Raloxifene