Raloxifene Data Lives Up To Expectations

Eli Lilly has reported pivotal Phase III data from a trial of itsselective estrogen receptor modulator raloxifene, which indicate that the drug may be a new therapeutic option in the prevention of postmenopausal osteoporosis. The data were presented at the 4th International Symposium on Osteoporosis Research Advances and Clinical Applications in Washington DC, USA.

Selective estrogen receptor modulators work by mimicking the effect of estrogen in certain parts of the body whilst inhibiting its effects in others. In this way, estrogen's beneficial effects on bone and the cardiovascular system are hopefully retained, while the negative consequences of the hormone, such as an increased risk of uterine cancer and perhaps breast cancer, are avoided. Other side effects of estrogen replacement include continuation of menstruation and breast pain.

In the Phase III studies reported in Washington, raloxifene was shown to prevent bone loss in the spine and hip compared with placebo plus calcium supplementation. The drug increased bone mineral density, an indicator of risk for fracture, by 2%-3% compared with placebo at all skeletal sites measured (hip, spine and total body).