Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS).
Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS).
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DOI：
10.1007/s00223-009-9299-6
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发表时间：
2009-12
影响因子：
4.2
通讯作者：
Marin, Fernando
中科院分区：
文献类型：
--
作者：
Langdahl, Bente L.;Rajzbaum, Gerald;Jakob, Franz;Karras, Dimitrios;Ljunggren, Osten;Lems, Willem F.;Fahrleitner-Pammer, Astrid;Walsh, J. Bernard;Barker, Clare;Kutahov, Alexey;Marin, Fernando
欧洲Forsteo观察性研究旨在检查特立帕肽在8个欧洲国家正常临床实践中治疗长达18个月的绝经后骨质疏松症妇女的有效性。评估临床椎体和非椎体脆性骨折、背痛和健康相关生活质量（HRQoL, EQ-5D）的发生率。收集不良事件的自发报告。所有1648名入组女性均为初治特立帕肽，其中91.0%曾接受过其他抗骨质疏松药物治疗，72.8%完成了为期18个月的研究。138例（8.8%）女性共发生168例临床骨折（821例/ 10000患者年）。与前6个月相比，后6个月骨折的几率降低了47% （P < 0.005）。平均腰痛VAS在结束时减少25.8 mm （P < 0.001）。18个月时EQ-VAS与基线的平均变化为13毫米。据报道，最大的改善是在EQ-5D的日常活动和疼痛/不适子域。有365例不良事件自发报告，其中48.0%认为与特立帕肽有关；不良事件是79例（5.8%）患者停药的原因。总之，绝经后患有严重骨质疏松症的妇女在标准临床实践中服用特立帕肽，在18个月的治疗期间，脆性骨折的发生率显著降低，背部疼痛减轻。这与HRQoL的临床显著改善相关。安全性与目前的处方信息一致。这些结果应该在开放标签、非对照研究设计的背景下进行解释。
The European Forsteo Observational Study was designed to examine the effectiveness of teriparatide in postmenopausal women with osteoporosis treated for up to 18 months in normal clinical practice in eight European countries. The incidence of clinical vertebral and nonvertebral fragility fractures, back pain, and health-related quality of life (HRQoL, EQ-5D) were assessed. Spontaneous reports of adverse events were collected. All 1,648 enrolled women were teriparatide treatment-naive, 91.0% of them had previously received other anti-osteoporosis drugs, and 72.8% completed the 18-month study. A total of 168 incident clinical fractures were sustained by 138 (8.8%) women (821 fractures/10,000 patient-years). A 47% decrease in the odds of fracture in the last 6-month period compared to the first 6-month period was observed (P < 0.005). Mean back pain VAS was reduced by 25.8 mm at end point (P < 0.001). Mean change from baseline in EQ-VAS was 13 mm by 18 months. The largest improvements were reported in the EQ-5D subdomains of usual activities and pain/discomfort. There were 365 adverse events spontaneously reported, of which 48.0% were considered related to teriparatide; adverse events were the reason for discontinuation for 79 (5.8%) patients. In conclusion, postmenopausal women with severe osteoporosis who were prescribed teriparatide in standard clinical practice had a significant reduction in the incidence of fragility fractures and a reduction in back pain over an 18-month treatment period. This was associated with a clinically significant improvement in HRQoL. Safety was consistent with current prescribing information. These results should be interpreted in the context of the open-label, noncontrolled design of the study.
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影响因子：
4
作者：
Cooper, C.;Jakob, F.;Marin, F.
通讯作者：
Marin, F.
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通讯作者：
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