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Women with chronic kidney disease benefit from raloxifene

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In postmenopausal women with mild to moderate chronic kidney disease, raloxifene increases bone mineral density and reduces the risk of vertebral fractures.

Using data from the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, researchers from Minnesota, California and Canada examined the efficacy of raloxifene (Evista, Eli Lilly) in 7,705 postmenopausal women with osteoporosis and chronic kidney disease. The researchers analyzed the rate of change in BMD, fracture incidence and adverse events over a three-year period to determine the safety and efficacy of raloxifene in this group of patients.

Compared with patients assigned to placebo, those assigned to raloxifene experienced a greater reduction in vertebral fractures and an increase in spine BMD, irrespective of kidney function. Researchers found a greater effect of raloxifene on hip BMD in those women with mild to moderate chronic kidney disease.

Lower baseline creatinine clearance was associated with greater loss of femoral neck BMD in the placebo group, but associated with greater increases in femoral neck BMD in the raloxifene group, the researchers wrote.

According to the researchers, adverse events were similar in the raloxifene and placebo groups, regardless of kidney function category. – by Stacey L. Adams

J Am Soc Nephrol. 2008;doi: 10.1681/ASN.2007050555.

An unmet need remains to identify bone loss treatments that show efficacy and are well-tolerated in patients with chronic kidney disease. In this retrospective analysis of the MORE trial, the authors demonstrated skeletal benefit with raloxifene compared with placebo, as judged by BMD and fracture risk, across tertiles of creatinine clearance. As the authors point out, clinical trial entry criteria across many pivotal osteoporosis studies prevented enrollment of subjects with advanced chronic kidney disease. Prospective study of subjects with impaired renal function with agents for treatment of bone loss will help validate these findings.

– Rachel B. Wagman, MD

Adjunct Clinical Assistant Professor
Department of Medicine, Stanford University School of Medicine