Raloxifene Safely Reduces Vertebral Fractures After Menopause

Laurie Barclay, MD

October 04, 2002

Oct. 7, 2002 — Results from the Multiple Outcomes of Raloxifene (MORE) trial suggest that raloxifene is safe and effective in postmenopausal osteoporosis, according to two presentations at the North American Menopause Society 13th Annual Meeting. The drug reduces vertebral fractures over the course of four years, and it does not increase early cardiovascular (CV) events; it may even reduce them in the second year of treatment.

"Raloxifene did not affect the yearly risk of CV events in osteoporotic postmenopausal women at lower or higher risk for CV events," write C. Keech, MD, PhD, from Lilly Research Laboratories in Indianapolis, Indiana, and colleagues. "The cumulative CV risk reduction [40% at four years] among higher-risk women was related to consistently fewer events in the raloxifene group starting from the second year of the trial."

In the MORE trial, osteoporotic postmenopausal women were randomized to daily treatment for four years with placebo (n=2,576) or raloxifene 60 mg (n=2,557). Subjects had low bone mineral density and/or pre-existing vertebral fractures at study enrollment.

In the whole cohort, raloxifene decreased the risk of new vertebral fractures compared with placebo (relative risk [RR], 0.64; 95% confidence interval [CI], 0.53-0.76}. To prevent one new vertebral fracture, 22 women would have to be treated with raloxifene for four years (number needed to treat [NNT], 22). Women with pre-existing vertebral fractures who were at higher risk of subsequent fractures had a 34% risk reduction with raloxifene (RR, 0.66; 95% CI, 0.55-0.81; NNT, 12).

"Raloxifene 60 mg/day decreased the incidence of new vertebral fractures at four years in women with and women without a pre-existing vertebral fracture at baseline," write M. Wong, PhD, from Lilly, and colleagues.

NAMS 13th Annual Meeting: Abstracts LB-1, P-47. Oct. 3-5, 2002.

Reviewed by Gary D. Vogin, MD