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Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS)

机译:特立帕肽对骨质疏松症患者的临床实践影响:欧洲扩展的Forsteo®观察研究(ExFOS)停止治疗期间和之后42个月的结果

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摘要

This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months’ post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study.Electronic supplementary materialThe online version of this article (10.1007/s00223-018-0437-x) contains supplementary material, which is available to authorized users.
机译:这项研究旨在描述开具特立帕肽治疗的患者的临床结局,并在现实生活中停药后进行了18个月的随访。扩展的Forsteo®观察性研究使用重复测量的Logistic回归分析以6个月为间隔对临床骨折进行了分析。使用重复测量的混合模型分析了背痛(视觉模拟量表)和健康相关生活质量(HRQoL; EQ-5D问卷)的变化。对患者是否进行过基线访视进行了分析,无论他们是否服用特立帕肽以及服用多长时间。在分析的1531名患者中(女性为90.7%,平均年龄:70.3岁),有76名(5.0%)从未服用过特立帕肽。中位治疗时间为23.6个月。在> 612至18个月的治疗期中,临床骨折的调整后几率与前6个月期相比降低了47%(p = 0.013),而在> 18至24个月的区间中,无统计学显着降低。在特立帕肽治疗后的18个月中,当大约98%的患者服用骨质疏松症药物(51%的双膦酸盐类药物)时,临床骨折率保持稳定。与前6个月相比,每个时期的临床椎骨骨折都减少了。每次基线观察后,调整后的平均背痛评分降低,EQ-5D评分显着提高。在现实生活中,特立帕肽治疗24个月内发生临床骨折的风险有所降低。停止使用特立帕肽后18个月,这种减少一直维持。同时,患者报告了背部疼痛和HRQoL的明显改善。结果应在本观察性研究的非对照设计范围内进行解释。电子补充材料本文的在线版本(10.1007 / s00223-018-0437-x)包含补充材料,授权用户可以使用。

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