Do Women and Men Respond Similarly to Therapies in Contemporary Heart Failure Clinical Trials?
Do Women and Men Respond Similarly to Therapies in Contemporary Heart Failure Clinical Trials?
复制标题
在当代心力衰竭临床试验中，女性和男性对治疗的反应是否相似？
DOI：
10.1016/j.jchf.2018.12.016
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发表时间：
2019
期刊：
影响因子：
--
通讯作者：
Butler,Javed
中科院分区：
文献类型：
--
作者：
Vaduganathan,Muthiah;Tahhan,AymanSamman;Alrohaibani,Alaaeddin;Greene,StephenJ;Fonarow,GreggC;Vardeny,Orly;Lindenfeld,JoAnn;Jessup,Mariell;Fiuzat,Mona;O'Connor,ChristopherM;Butler,Javed
在美国，目前患有心力衰竭（HF）的女性多于男性（1）;预计这种不平衡将在未来十年持续存在（2）。性别影响HF的生物学驱动因素、病因学、背景流行病学、风险标志物和护理质量。为了增加女性参与临床试验，美国食品和药物管理局（FDA）自20世纪90年代初以来发布了一系列有针对性的指导文件和法规。FDA现在要求所有申办者在药物和器械的监管批准申请中纳入女性的疗效和安全性数据，并在产品标签中披露任何有意义的性别差异（在线参考文献1）。美国国立卫生研究院（NIH）同样支持在所有NIH资助的III期临床试验中充分招募和报告基于性别的亚组信息（在线参考文献2）。
More women than men currently live with heart failure (HF) in the United States (1); this imbalance is projected to persist over the next decade (2). Sex influences biologic drivers, etiologies, background epidemiology, markers of risk, and care quality in HF. To bolster enrollment of women in clinical trials, the US Food and Drug Administration (FDA) has published a series of targeted guidance documents and regulations since the early 1990s. The FDA now requires all sponsors to include efficacy and safety data in women in applications for regulatory approval of drugs and devices, and to disclose any meaningful sex-based differences in product labeling (Online Ref. 1). The National Institutes of Health (NIH) have similarly supported adequate enrollment and reporting of sex-based subgroup information in all NIH-funded phase 3 clinical trials (Online Ref. 2).
影响因子：
37.8
作者：
Jersey Chen;S. Normand;Yun Wang;H. Krumholz
通讯作者：
Jersey Chen;S. Normand;Yun Wang;H. Krumholz