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阿巴洛肽治疗绝经后骨质疏松症有效:与特立帕肽相比的治疗需要人数。

Abaloparatide is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide.

机构信息

Université de Liège, Place du 20-Août, 7, 4000, Liège, Belgium.

Radius Health, Inc., 950 Winter St, Waltham, MA, 02451, USA.

出版信息

Calcif Tissue Int. 2018 Nov;103(5):540-545. doi: 10.1007/s00223-018-0450-0. Epub 2018 Jun 27.

Abstract

Abaloparatide (ABL) is a 34-amino acid peptide designed to be a selective activator of the parathyroid hormone receptor type 1 signaling pathway. In the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), subcutaneous ABL reduced the risk of new vertebral, nonvertebral, clinical, and major osteoporotic fracture compared with placebo and of major osteoporotic fracture compared with teriparatide. To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data. To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE. NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE. The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials. NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture. NNT for these fracture types for teriparatide in ACTIVE were 30, 92, 59, and 75, respectively. Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31. These data are useful for further evaluating ABL for the treatment of osteoporosis in postmenopausal women.

摘要

阿巴洛肽(ABL)是一种 34 个氨基酸的肽,旨在成为甲状旁腺激素受体 1 信号通路的选择性激活剂。在阿巴洛肽比较试验在椎体终点(ACTIVE)中,与安慰剂相比,皮下注射 ABL 降低了新发椎体、非椎体、临床和主要骨质疏松性骨折的风险,与特立帕肽相比,降低了主要骨质疏松性骨折的风险。为了进一步评估 ABL 的有效性,我们根据 ACTIVE 数据计算了预防一次骨折所需的治疗人数(NNT)。为了估计 ABL 在骨折风险高于 ACTIVE 的人群中的潜在有效性,我们使用历史安慰剂对照试验的参考人群计算了椎体骨折的 NNT,假设 ABL 治疗可使椎体骨折的相对风险降低 86%,如 ACTIVE 中观察到的那样。NNT 计算为 ACTIVE 中绝对风险降低的倒数。根据 FREEDOM(安慰剂 IR7.2%)、FIT-1(安慰剂 IR15.0%)和 FIT-2(安慰剂 IR3.8%)试验安慰剂臂中的椎体骨折发生率(IR),计算了其他人群中 ABL 的预计 NNT。ABL 在 ACTIVE 中的 NNT 为椎体骨折 28,非椎体骨折 55,临床骨折 37,主要骨质疏松性骨折 34。ABL 在 ACTIVE 中治疗这些骨折类型的 NNT 分别为 30、92、59 和 75。使用 FREEDOM、FIT-1 和 FIT-2 的安慰剂 IR,预计 ABL 治疗椎体骨折的 NNT 分别为 17、8 和 31。这些数据有助于进一步评估阿巴洛肽治疗绝经后妇女骨质疏松症的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/98a5/6182596/6283144e23f3/223_2018_450_Fig1_HTML.jpg

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