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Lasofoxifene Reduces Fracture Risk After 5 Years, But Increases Risk of VTE BOSTON -- February 26, 2010 -- Lasofoxifene (Fablyn) reduces the risk of fractures in postmenopausal women with osteoporosis, compared with placebo, and is associated with a lower risk of some breast cancers, coronary heart disease, and stroke, according to a study published in this week’s issue of the New England Journal of Medicine. In an accompanying commentary, however, reviewer Carolyn Becker, MD, Brigham and Women’s Hospital, Boston, Massachusetts, said: “My conclusion after looking at all the data is that it does not offer enough advantages to warrant switching from a drug I’m familiar with.” In the randomised study, 8,556 postmenopausal women with osteoporosis were treated with either lasofoxifene 0.25 or 0.50 mg/day or placebo. After 5 years, data showed that patients treated with lasofoxifene had a lower risk of vertebral and nonvertebral fractures, compared with those who received placebo. For the higher dose of lasofoxifene, the risk for nonvertebral fractures was reduced by 24% compared with placebo, and the risk for vertebral fractures was reduced by 42%. The risk of breast cancer was reduced by more than half, compared with placebo, while the risks of stroke and coronary heart disease events were reduced by 36% and 32%, respectively. However, data showed that lasofoxifene was associated with more than double the risk of blood clots, compared with placebo: 3.8 cases per 1,000 person years for the lower dose and 2.9 cases for the higher dose, versus 1.4 cases in the placebo arm. The authors noted these rates are similar to other selective oestrogen-receptor modulators. In addition, there were more cases of lung cancer in the lasofoxifene group than in the placebo group, though this was not statistically significant. In her commentary, Becker said that the benefit for reducing nonvertebral fractures took 5 years to take effect and that the absolute risk reductions were small. She also wrote that lasofoxifene “offers no major clinically important benefits over [raloxifene] for the skeleton, breast, heart, or reproductive tract.” SOURCE: New England Journal of Medicine E-mail this page to a friend or colleague! To print, use this version