美国实际接受特立帕肽治疗的患者中髋部及其他脆性骨折的发生率
Hip and other fragility fracture incidence in real-world teriparatide-treated patients in the United States.
作者信息
Burge R T, Disch D P, Gelwicks S, Zhang X, Krege J H
机构信息
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.
University of Cincinnati, Cincinnati, OH, USA.
出版信息
Osteoporos Int. 2017 Mar;28(3):799-809. doi: 10.1007/s00198-016-3888-9. Epub 2016 Dec 27.
UNLABELLED
This study demonstrates real-world effectiveness of teriparatide in reducing the risk of hip and other fragility fractures. Fracture incidence significantly decreased as adherence and persistence increased for any clinical, vertebral, nonvertebral, and hip fractures among patients who were observed for 2 years after teriparatide initiation.
INTRODUCTION
Examine the relationship of treatment adherence and persistence to teriparatide with hip and other fractures.
METHODS
Truven MarketScan Research Databases, 2004 through 2014, provided teriparatide users ≥18 years old with continuous coverage 12 months pre- and 24 months post-teriparatide prescription. Adherence (medication possession ratio, MPR) groups were defined as high (≥0.80), medium (0.50 ≤ MPR < 0.80), and low (<0.50). Persistence, allowing for ≤90-day gaps between prescriptions, was defined as 1-6, 7-12, 13-18, and 19-24 months. Fracture incidence was summarized and compared by using ANOVA and logistic regression models; the effects of adherence were examined with Cox proportional hazard models with time-dependent covariates for teriparatide exposure.
RESULTS
Among 14,284 teriparatide subjects, mean age was 68.4 years, 89.8% were female, and 29.6% had a fracture in the previous year; these characteristics were similar across MPR and persistence groups. The effects of adherence and persistence to teriparatide were statistically significant (P < .001) for all fracture types except wrist (P ≥ .125). By logistic regression, high vs low adherence was associated with reduced risk for any (OR = 0.67; P < .001); vertebral (OR = 0.64; P < .001); nonvertebral (OR = 0.71; P < .001); and hip fractures (OR = 0.52; P < .001) and longer (19-24 months) vs shorter persistence (1-6 months) was associated with reduced risk for any (OR = 0.63, P < .001); vertebral (OR = 0.56, P < .001); nonvertebral (OR = 0.69, P < .001); and hip fractures (OR = 0.48, P < .001). Cox models revealed a significantly reduced risk between high and low adherence for any (OR = 0.69, P < .001); vertebral (OR = 0.60, P < .001); nonvertebral (OR = 0.77, P < .001); and hip fractures (OR = 0.55, P < .001).
CONCLUSION
Fracture incidence significantly decreased as persistence and adherence to teriparatide increased.
未标注
本研究证明了特立帕肽在降低髋部及其他脆性骨折风险方面的实际效果。在开始使用特立帕肽后观察2年的患者中，随着依从性和持续性的增加，任何临床骨折、椎体骨折、非椎体骨折和髋部骨折的发生率均显著降低。
引言
研究特立帕肽的治疗依从性和持续性与髋部及其他骨折之间的关系。
方法
2004年至2014年的Truven MarketScan研究数据库为年龄≥18岁的特立帕肽使用者提供了特立帕肽处方前12个月和处方后24个月的连续保险覆盖。依从性（药物持有率，MPR）组定义为高（≥0.80）、中（0.50≤MPR<0.80）和低（<0.50）。持续性定义为1 - 6、7 - 12、13 - 18和19 - 24个月，允许处方之间的间隔≤90天。通过方差分析和逻辑回归模型总结并比较骨折发生率；使用具有时间依赖性协变量的Cox比例风险模型检查依从性对特立帕肽暴露的影响。
结果
在14284名特立帕肽受试者中，平均年龄为68.4岁，89.8%为女性，29.6%在前一年发生过骨折；这些特征在MPR和持续性组中相似。除腕部骨折外（P≥0.125），特立帕肽的依从性和持续性对所有骨折类型的影响均具有统计学意义（P<0.001）。通过逻辑回归，高依从性与低依从性相比，任何骨折（OR = 0.67；P<0.001）、椎体骨折（OR = 0.64；P<0.001）、非椎体骨折（OR = 0.71；P<0.001）和髋部骨折（OR = 0.52；P<0.001）的风险降低相关；持续性较长（19 - 24个月）与较短（1 - 6个月）相比，任何骨折（OR = 0.63，P<0.001）、椎体骨折（OR = 0.56，P<0.001）、非椎体骨折（OR = 0.69，P<0.001）和髋部骨折（OR = 0.48，P<0.001）的风险降低相关。Cox模型显示，高依从性与低依从性相比，任何骨折（OR = 0.69，P<0.001）、椎体骨折（OR = 0.60，P<0.001）、非椎体骨折（OR = 0.77，P<0.001）和髋部骨折（OR = 0.55，P<0.001）的风险显著降低。
结论
随着对特立帕肽的持续性和依从性增加，骨折发生率显著降低。
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