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Osteoporosis Drug May Fight Several Diseases

Study Shows Lasofoxifene Cuts Risk of Breast Cancer, Heart Attack, and Stroke

Do We Need Another Osteoporosis Drug?

In an editorial that accompanies the study, Caroline Becker, MD, of Brigham and Women's Hospital in Boston, questions whether the benefits of lasofoxifene shown in this PEARL (Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene) study are enough to merit entering an already crowded field of osteoporosis drugs.

According to PEARL study information submitted to the FDA, Becker says, lasofoxifene did not reduce the risk of new, symptomatic vertebral fractures after three years of treatment. Instead it only reduced the risk of vertebral fractures as shown by radiological (X-ray) evidence at five years.

In contrast, another SERM, raloxifene (Evista), has been shown to significantly reduce both new symptomatic vertebral fractures as well as those shown by X-rays.

"On balance, lasofoxifene seems to offer little, if any, advantage over raloxifene as an agent against osteoporosis," Becker writes. "Although the cardiovascular benefits reported in the PEARL trial seem impressive, one would need to treat 492 patients for one year to prevent a single major coronary event."

Also, because lasofoxifene has not been tested in women at high risk for heart disease, its safety in this group is unknown, she says.

"Given the plethora of drugs currently available for osteoporosis, studies of new agents should show clear benefits over existing agents," Becker writes. "On the basis of this criterion, the results of the PEARL trial suggest that lasofoxifene offers no major clinically important benefits over raloxifene for the skeleton, breast, heart, or reproductive tract."

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