Eli Lilly's Evista shows efficacy in osteoporosis treatment

Eli Lilly's selective estrogen receptor modulator Evista (raloxifene),already on the market for the prevention of postmenopausal osteoporosis, has been shown in a treatment trial to be effective in reducing vertebral fracture risk among osteoporotic postmenopausal women, according to new data published in the Journal of the American Medical Association (August 18). The US Food and Drug Administration has designated the drug a priority review for this indication.

A total of 7,705 women aged 31 to 80 years have been enrolled in the ongoing Multiple Outcomes of Raloxifene Evaluation trial, which began in 1994. To qualify for participation, enrollees must have been postmenopausal for at least two years and have met World Health Organization criteria for osteoporosis.

Participants were randomized to receive either 60mg or 120mg per day of Evista or placebo (the marketed dose of Evista is 60mg) and all patients were administered supplemental calcium and cholecalciferol (vitamin D). Vertebral fracture was assessed at baseline, and at scheduled 24- and 36-month follow-ups, while non-vertebral fracture was determined at six-month interim visits. Bone mineral density was ascertained using dual-energy X-ray absorptiometry on an annual basis.