Department of Endocrinology and Metabolism C, Aarhus University Hospital, Aarhus, Denmark.
Int J Womens Health. 2010 Aug 9;1:97-103. doi: 10.2147/ijwh.s5616.
Several categories of drugs to treat osteoporosis exist in the form of bisphosphonates, strontium, parathyroid hormone, and selective estrogen receptor modulators (SERM). Advantages and disadvantages exist for each category as some patients may, for example, not tolerate bisphosphonates for gastrointestinal side effects, and especially in women in whom osteoporosis is frequent, several options for treatment are needed. The objectives of this review were to critically appraise the effects of bazedoxifene on risk of fractures especially in women at high risk of fractures. A systematic literature search was conducted for studies, especially randomized controlled trials with fractures as end-points. Bazedoxifene is a new member of the SERM group. The literature search identified one randomized controlled trial with fractures as end-point. This was a 3-year randomized double-blind placebo controlled trial in which 7492 postmenopausal women aged 55 to 85 years were randomly allocated to 1) bazedoxifene (20 [n = 1886] or 40 [n = 1872] mg/day); 2) raloxifene (60 mg/day, n = 1849); or 3) placebo (n = 1885). The risk of vertebral fractures decreased with both 20 (HR 0.58, 95% CI 0.38 to 0.89) and 40 (HR 0.63, 95% CI 0.42 to 0.96) mg of bazedoxifene per day compared to placebo. There was no reduction in non-vertebral fractures. A subgroup of women with a priori high risk of fractures was identified post hoc. In this subgroup there was a reduction in the risk of non-vertebral fractures with the 20 mg dose of bazedoxifene compared to placebo (HR 0.50, 95% CI 0.28 to 0.90). In the 40 mg bazedoxifene group no significant reduction in non-vertebral fractures was seen in this subgroup (HR 0.70, 95% CI 0.40 to 1.20). In general post-hoc defined subgroup analyses should be interpreted with caution. However, the results indicate that bazedoxifene may be effective in preventing vertebral fractures in postmenopausal women with osteoporosis.
存在几类治疗骨质疏松症的药物，包括双膦酸盐、锶、甲状旁腺激素和选择性雌激素受体调节剂（SERM）。每种类别都有其优缺点，例如，一些患者可能因胃肠道副作用而无法耐受双膦酸盐，而对于骨质疏松症频繁发生的女性，需要多种治疗选择。本综述的目的是批判性地评估巴多昔芬对骨折风险的影响，特别是对骨折高风险的女性。进行了系统的文献检索，以寻找以骨折为终点的研究，特别是随机对照试验。巴多昔芬是 SERM 组的新成员。文献检索确定了一项以骨折为终点的随机对照试验。这是一项为期 3 年的随机双盲安慰剂对照试验，其中 7492 名 55 至 85 岁的绝经后妇女被随机分配到以下 3 组：1）巴多昔芬（20 [n = 1886] 或 40 [n = 1872] mg/天）；2）雷洛昔芬（60 mg/天，n = 1849）；或 3）安慰剂（n = 1885）。与安慰剂相比，每日 20（HR 0.58，95%CI 0.38 至 0.89）和 40（HR 0.63，95%CI 0.42 至 0.96）mg 巴多昔芬可降低椎体骨折风险。非椎体骨折无减少。根据后验分析确定了一个骨折风险高的女性亚组。在这个亚组中，与安慰剂相比，每日 20 mg 巴多昔芬可降低非椎体骨折的风险（HR 0.50，95%CI 0.28 至 0.90）。在 40 mg 巴多昔芬组中，在这个亚组中未观察到非椎体骨折的显著减少（HR 0.70，95%CI 0.40 至 1.20）。一般来说，后验定义的亚组分析应谨慎解释。然而，结果表明，巴多昔芬可能对预防绝经后骨质疏松症女性的椎体骨折有效。
