Mapi, Boston, MA, USA.
University of Liège, Belgium.
Value Health. 2014 Jun;17(4):424-32. doi: 10.1016/j.jval.2014.01.008. Epub 2014 May 5.
To compare the efficacy of bazedoxifene and oral bisphosphonates for the prevention of nonvertebral fractures (NVFs) in women with higher risk of postmenopausal osteoporosis (i.e., the Fracture Risk Assessment Tool [FRAX] score ≥ 20%), based on currently available evidence from randomized controlled trials.
Randomized controlled trials evaluating the NVF relative risk reduction (RRR) with oral bisphosphonates or bazedoxifene were identified by a systematic literature review and combined by means of a network meta-analysis. A subgroup of patients with a FRAX score of 20% or more in the bazedoxifene phase III osteoporosis study was selected as the population of interest on the basis of the bazedoxifene label. In one analysis (analysis 1), the placebo response of the subgroup with a FRAX score of 20% or more was the benchmark to select comparable bisphosphonate trials. Additional analyses incorporated the aggregate data from the bisphosphonate trials with all the FRAX subgroups (analysis 2) or with the individual patient data from the bazedoxifene trial (analysis 3).
Nine identified bisphosphonate trials (alendronate, ibandronate, risedronate; N = 23,440 patients) with a similar placebo response as observed for the subgroup of high risk patients in the bazedoxifene trial were included in analysis 1. The results of the network meta-analysis of this study set suggest that bazedoxifene is expected to have an RRR of 0.43 (95% credible interval [CrI] -0.19 to 0.72) versus alendronate, 0.58 (95% CrI 0.05-0.81) versus ibandronate, and 0.39 (95% CrI -0.29 to 0.70) versus risedronate. Analyses in which treatment effects with bisphosphonates were projected to a population with a FRAX score of 20% or more with meta-regression approaches (analysis 2 and analysis 3) provide similar findings.
Based on an indirect comparison of randomized trials, bazedoxifene is expected to have at least a comparable RRR of NVF as alendronate, ibandronate, and risedronate in women with higher risk of postmenopausal osteoporosis.
基于目前随机对照试验的证据，比较巴多昔芬和口服双膦酸盐在预防绝经后骨质疏松症高危女性（即骨折风险评估工具[FRAX]评分≥20%）的非椎体骨折（NVFs）的疗效。
通过系统文献回顾确定了评估口服双膦酸盐或巴多昔芬与 NVF 相对风险降低（RRR）的随机对照试验，并通过网络荟萃分析进行了合并。根据巴多昔芬骨质疏松症三期研究中 FRAX 评分≥20%的患者亚组的巴多昔芬标签，选择了该研究人群作为感兴趣的人群。在一项分析（分析 1）中，将 FRAX 评分≥20%的亚组的安慰剂反应作为选择可比双膦酸盐试验的基准。其他分析纳入了来自双膦酸盐试验的汇总数据，包括所有 FRAX 亚组（分析 2）或来自巴多昔芬试验的个体患者数据（分析 3）。
纳入了 9 项已确定的双膦酸盐试验（阿仑膦酸钠、伊班膦酸钠、利塞膦酸钠；N=23440 名患者），这些试验的安慰剂反应与巴多昔芬试验中高危患者亚组的观察结果相似，纳入了分析 1。该研究设定的网络荟萃分析结果表明，与阿仑膦酸钠相比，巴多昔芬预计 RRR 为 0.43（95%可信区间[CrI] -0.19 至 0.72），与伊班膦酸钠相比为 0.58（95% CrI 0.05-0.81），与利塞膦酸钠相比为 0.39（95% CrI -0.29 至 0.70）。通过荟萃回归方法（分析 2 和分析 3）预测在 FRAX 评分≥20%的人群中，双膦酸盐治疗效果的分析得出了类似的结果。
基于随机试验的间接比较，巴多昔芬在绝经后骨质疏松症高危女性中预防 NVF 的 RRR 预计至少与阿仑膦酸钠、伊班膦酸钠和利塞膦酸钠相当。
