绝经后骨质疏松症患者使用 Romosozumab 与常用抗骨质疏松症药物相比的心血管安全性:随机对照试验的系统回顾和网络 Meta 分析》。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-09-03 DOI:10.1007/s40264-024-01475-9
Shih-Hao Cheng, William Chu, Wen-Hsiang Chou, Woei-Chyn Chu, Yi-No Kang
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摘要

简介本研究旨在调查罗莫司单抗对绝经后骨质疏松症妇女心血管的安全性。罗莫索单抗是一种靶向硬骨素的单克隆抗体,已被证明可增加骨矿密度并降低骨质疏松性骨折的风险。然而,在之前的研究中,罗莫索单抗疗法被认为是心血管事件的潜在风险因素,尤其是在易患心血管疾病的患者中:在Cochrane图书馆、Embase、PubMed和Web of Science数据库中进行了系统性文献检索,以确定在绝经后骨质疏松症女性患者中比较romosozumab与阿仑膦酸钠、特立帕肽、地诺单抗或安慰剂的安全性和有效性的随机对照试验(RCT)。采用随机效应模型进行了基于对比的网络荟萃分析。汇总的估计值以风险比和95%置信区间表示:在检索到的 5282 篇文章中,有 25 项随机对照试验(n = 24942)被纳入本综述,18 项随机对照试验(n = 16777)被纳入网络荟萃分析。结果表明,罗莫单抗与安慰剂在心血管死亡率方面无明显差异。关于主要心血管事件的风险,直接证据和以安慰剂为参照物的网络荟萃分析均未发现明显差异:结论:罗莫单抗可能是治疗绝经后妇女骨质疏松症的一种安全选择。结论:罗莫司单抗可能是治疗绝经后妇女骨质疏松症的安全选择,与这种治疗方法相关的心血管问题似乎没有以前认为的那么严重,尽管还需要更多的真实世界数据来证实这一结论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.

Introduction: The aim of this study was to investigate the cardiovascular safety of romosozumab in postmenopausal women with osteoporosis. Romosozumab, a monoclonal antibody targeting sclerostin, has been shown to increase bone mineral density and reduce the risk of osteoporotic fractures. However, in previous studies, romosozumab therapy was identified as a potential risk factor for cardiovascular events, particularly in patients with predisposing cardiovascular disease.

Methods: A systematic literature search was performed in the Cochrane Library, Embase, PubMed, and Web of Science databases to identify randomized controlled trials (RCTs) comparing the safety and efficacy of romosozumab versus alendronate, teriparatide, denosumab, or placebo in postmenopausal women with osteoporosis. Contrast-based network meta-analysis was performed using a random-effects model. The pooled estimates are presented as risk ratios with 95% confidence intervals.

Results: Of the 5282 articles retrieved, 25 RCTs were included in this review (n = 24,942), and 18 randomized controlled trials (n = 16,777) were included in the network meta-analysis. The results indicated no significant differences in cardiovascular mortality rate between romosozumab and placebo. Regarding the risk of major cardiovascular events, no significant differences were found in the direct evidence or the network meta-analysis with placebo as the reference.

Conclusion: Romosozumab might be a safe option for treating postmenopausal women with osteoporosis. The cardiovascular concerns associated with this treatment seem less significant than previously suggested, although additional real-world data are required to confirm this conclusion.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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