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阿巴洛肽:一种用于减少绝经后骨质疏松症女性骨折风险的合成代谢治疗药物。

Abaloparatide: an anabolic treatment to reduce fracture risk in postmenopausal women with osteoporosis.

机构信息

Colorado Center for Bone Research, Denver, CO, USA.

Colorado Center for Bone Health, Golden, CO, USA.

出版信息

Curr Med Res Opin. 2020 Nov;36(11):1861-1872. doi: 10.1080/03007995.2020.1824897. Epub 2020 Oct 12.

Abstract

OBJECTIVE

Fractures due to osteoporosis represent a serious burden on patients and healthcare systems. The objective of this review is to provide an overview of the anabolic agent abaloparatide (ABL) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

METHODS

A literature review was conducted using PubMed to identify articles focused on ABL published prior to February 10, 2020, using the search term "abaloparatide".

RESULTS

ABL, a synthetic analog of human parathyroid hormone-related protein, increased bone mineral density (BMD), improved bone microarchitecture, and increased bone strength in preclinical and clinical studies. The pivotal phase 3 trial ACTIVE and its extension (ACTIVExtend) demonstrated the efficacy of initial treatment with ABL for 18 months followed by sequential treatment with alendronate (ALN) for an additional 24 months to reduce the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and to increase BMD in postmenopausal women with osteoporosis. Discontinuations from ACTIVE were slightly more common in ABL-treated patients due to dizziness, palpitations, nausea, and headache. analyses of ACTIVE and ACTIVExtend support the efficacy and safety of ABL in relevant subpopulations including postmenopausal women with various baseline risk factors, women ≥80 years, women with type 2 diabetes mellitus, and women with renal impairment.

CONCLUSIONS

ABL is an effective and well-tolerated treatment for women with postmenopausal osteoporosis at high risk for fracture. Its therapeutic effects are sustained with subsequent ALN therapy.

摘要

目的

骨质疏松症导致的骨折给患者和医疗系统带来了严重负担。本综述的目的是概述阿巴洛肽(ABL)在治疗有高骨折风险的绝经后骨质疏松症妇女中的应用,这些妇女存在骨质疏松症。

方法

使用 PubMed 进行文献回顾,以确定在 2020 年 2 月 10 日之前发表的关于 ABL 的文章,使用的搜索词是“abaloparatide”。

结果

ABL 是人类甲状旁腺激素相关蛋白的合成类似物,在临床前和临床试验中增加了骨矿物质密度(BMD),改善了骨微观结构,增强了骨强度。关键性的 3 期试验 ACTIVE 及其扩展试验(ACTIVExtend)表明,初始治疗 18 个月后用 ABL 治疗,随后用阿仑膦酸钠(ALN)治疗 24 个月,可以降低椎体、非椎体、临床和主要骨质疏松性骨折的风险,并增加绝经后骨质疏松症妇女的 BMD。由于头晕、心悸、恶心和头痛,ABL 治疗组的停药率略高于 ALN 治疗组。对 ACTIVE 和 ACTIVExtend 的分析支持 ABL 在包括具有各种基线风险因素、年龄≥80 岁、患有 2 型糖尿病和肾功能损害的绝经后妇女在内的相关亚组中的疗效和安全性。

结论

ABL 是一种有效且耐受性良好的治疗绝经后骨质疏松症妇女高骨折风险的药物。其治疗效果在随后的 ALN 治疗中得以维持。

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