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绝经后女性新接受合成代谢治疗时阿巴洛肽和特立帕肽的疗效和心血管安全性比较:一项美国行政索赔数据库研究。

Comparative effectiveness and cardiovascular safety of abaloparatide and teriparatide in postmenopausal women new to anabolic therapy: A US administrative claims database study.

机构信息

Department of Medicine, Columbia University, New York, NY, USA.

MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton, UK.

出版信息

Osteoporos Int. 2022 Aug;33(8):1703-1714. doi: 10.1007/s00198-022-06413-y. Epub 2022 May 7.

Abstract

UNLABELLED

Real-world evidence on the comparative effectiveness and safety of abaloparatide versus teriparatide in women with osteoporosis may help inform treatment decisions. Following 18 months of treatment, abaloparatide was comparable to teriparatide for prevention of nonvertebral fractures, resulted in a 22% risk reduction for hip fractures, and demonstrated similar cardiovascular safety. Osteoporotic fracture risk can be reduced with anabolic or antiresorptive medications. In addition to efficacy and safety data from controlled clinical trials, real-world evidence on comparative effectiveness and safety may help inform treatment decisions.

INTRODUCTION

The real-world effectiveness of abaloparatide versus teriparatide on nonvertebral fracture (NVF) incidence and cardiovascular safety during the 19-month period after treatment initiation were evaluated (NCT04974723).

METHODS

Anonymized US patient claims data from Symphony Health, Integrated Dataverse (IDV)®, May 1, 2017 to July 31, 2019, included women aged ≥ 50 years with ≥ 1 prescription of abaloparatide or teriparatide and no prior anabolic therapy. Most were enrolled in commercial and Medicare health plans. Index was the date of the initial prescription dispensed during the identification period. In 1:1 propensity score matched cohorts, time to first NVF following index date, major adverse cardiovascular events (MACE), and MACE + heart failure (HF) were compared between cohorts using a Cox proportional hazards model.

RESULTS

Propensity score matching yielded 11,616 patients per cohort. Overall median age (interquartile range) was 67 (61, 75) years, and 25.6% had a fracture history. Over 19 months, 335 patients on abaloparatide and 375 on teriparatide had a NVF (hazard ratio [95% confidence interval]: 0.89 [0.77, 1.03]), and 121 and 154 patients, respectively, had a hip fracture [HR (95% CI): 0.78 (0.62, 1.00)]. The MACE and MACE + HF rates were similar between cohorts.

CONCLUSIONS

Following 18 months of treatment, abaloparatide was comparable to teriparatide for prevention of NVF and similar cardiovascular safety was demonstrated between cohorts.

摘要

未注明

关于阿巴洛肽与特立帕肽在骨质疏松症女性中的比较疗效和安全性的真实世界证据可能有助于治疗决策。经过 18 个月的治疗,阿巴洛肽在预防非椎体骨折方面与特立帕肽相当,髋部骨折风险降低 22%,且心血管安全性相似。抗吸收或合成代谢药物可降低骨质疏松性骨折风险。除了对照临床试验的疗效和安全性数据外,关于比较疗效和安全性的真实世界证据也可能有助于治疗决策。

简介

评估了阿巴洛肽与特立帕肽在治疗开始后 19 个月时对非椎体骨折(NVF)发生率和心血管安全性的真实世界疗效(NCT04974723)。

方法

利用 Symphony Health、Integrated Dataverse(IDV)®的匿名美国患者索赔数据,时间范围为 2017 年 5 月 1 日至 2019 年 7 月 31 日,纳入年龄≥50 岁、至少有 1 次阿巴洛肽或特立帕肽处方且无既往合成代谢治疗史的女性。大多数患者参加了商业和医疗保险健康计划。索引是识别期内首次开具处方的日期。在 1:1 倾向评分匹配队列中,使用 Cox 比例风险模型比较了队列之间首次 NVF 发生时间、主要不良心血管事件(MACE)和 MACE+心力衰竭(HF)。

结果

倾向评分匹配产生了每个队列 11616 名患者。总体中位年龄(四分位距)为 67(61,75)岁,25.6%有骨折史。在 19 个月期间,335 名阿巴洛肽患者和 375 名特立帕肽患者发生 NVF(风险比[95%置信区间]:0.89 [0.77,1.03]),分别有 121 名和 154 名患者发生髋部骨折[风险比(95%CI):0.78(0.62,1.00)]。队列之间的 MACE 和 MACE+HF 发生率相似。

结论

经过 18 个月的治疗,阿巴洛肽在预防 NVF 方面与特立帕肽相当,且队列之间的心血管安全性相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1728/9499892/db2f108a6605/198_2022_6413_Fig1_HTML.jpg

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