Raloxifene safe for women with kidney disease

NEW YORK (Reuters Health) - Treatment with raloxifene safely increases bone mineral density in postmenopausal women with chronic kidney disease, and also lowers their risk of vertebral fractures, according to an analysis of data from the Multiple Outcomes of Raloxifene Evaluation (MORE) trial.

Raloxifene is also known by the trade names Evista and Keoxifene.

Because patients with chronic kidney disease have an increased risk of bone loss, women with elevated creatinine levels - a sign of kidney failure -- are usually excluded from trials of drugs for osteoporosis, a bone-thinning disease common among postmenopausal women, according to the report in the Journal of the American Society of Nephrology.

Raloxifene, a drug that binds to estrogen receptors, can increase bone mineral density and lower the risk of vertebral fractures in postmenopausal women with osteoporosis, Dr. Areef Ishani and MORE co-investigator notes. Whether the presence of chronic kidney disease affects the safety and effectiveness of this drug, however, was unclear.

The 3-year trial included 7,316 women who had their creatinine clearance calculated, which is the average volume of creatinine in milliliters of urine excreted in one minute. The women were then separated into three groups based on the results: less than 45, 45 to 59, and 60 or more milliliters per minute. The normal range of creatinine clearance for men is 110 to 120 mL/min, and the average range for women is 100 t0 110 mL/min.

Bone mineral density was also measured at the beginning of the study and then annually. The women were randomly assigned to treatment with raloxifene or placebo.

Ishani, from the University of Minnesota in Minneapolis, and colleagues report that among women who took the placebo, a lower creatinine clearance at the start of the trial correlated with higher annual losses in bone mineral density at the hip.

In the raloxifene group, by contrast, lower clearance at the start of the trial correlated with greater increases in hip bone mineral density. A significant interaction between category of creatinine clearance and treatment assignment was noted for the rate of change in hip bone mineral density.