Déjà vu all over again: a recurrent flaw in anticoagulant study design.

IF 5.5 2区 医学 Q1 HEMATOLOGY
Bethany Samuelson Bannow, Alison Edelman, Marc Carrier
{"title":"Déjà vu all over again: a recurrent flaw in anticoagulant study design.","authors":"Bethany Samuelson Bannow, Alison Edelman, Marc Carrier","doi":"10.1016/j.jtha.2024.10.019","DOIUrl":null,"url":null,"abstract":"<p><p>The availability of direct oral anticoagulants (DOACs) rapidly changed the landscape of anticoagulation between 2010-present. Randomized controlled trials demonstrating efficacy with similar or superior safety compared to warfarin led to widespread use of DOACs in male and female patients of all ages. Years later, post-marketing data demonstrated a markedly increased rate of heavy menstrual bleeding (HMB) with rivaroxaban that had gone undetected in registry trials. Factor XI (FXI) inhibitors are currently being investigated as another alternative to available anticoagulation agents. While generally mild, the phenotype of inherited FXI deficiency includes bleeding in tissues with enhanced fibninolysis, including HMB. Thus, we aimed to perform a systematic review of published studies on FXI inhibitors in order to estimate rates of HMB. However, we found that few studies included menstruating individuals and even fewer specifically reported on uterine bleeding, highlighting once again a flaw in our approach to conducting trials of new anticoagulants.</p>","PeriodicalId":17326,"journal":{"name":"Journal of Thrombosis and Haemostasis","volume":null,"pages":null},"PeriodicalIF":5.5000,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Thrombosis and Haemostasis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jtha.2024.10.019","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

The availability of direct oral anticoagulants (DOACs) rapidly changed the landscape of anticoagulation between 2010-present. Randomized controlled trials demonstrating efficacy with similar or superior safety compared to warfarin led to widespread use of DOACs in male and female patients of all ages. Years later, post-marketing data demonstrated a markedly increased rate of heavy menstrual bleeding (HMB) with rivaroxaban that had gone undetected in registry trials. Factor XI (FXI) inhibitors are currently being investigated as another alternative to available anticoagulation agents. While generally mild, the phenotype of inherited FXI deficiency includes bleeding in tissues with enhanced fibninolysis, including HMB. Thus, we aimed to perform a systematic review of published studies on FXI inhibitors in order to estimate rates of HMB. However, we found that few studies included menstruating individuals and even fewer specifically reported on uterine bleeding, highlighting once again a flaw in our approach to conducting trials of new anticoagulants.

似曾相识:抗凝剂研究设计中反复出现的缺陷。
2010 年至今,直接口服抗凝剂 (DOAC) 的出现迅速改变了抗凝治疗的格局。随机对照试验表明,与华法林相比,直接口服抗凝剂具有相似或更优越的疗效和安全性,因此在所有年龄段的男性和女性患者中广泛使用直接口服抗凝剂。多年后,上市后的数据显示,利伐沙班的月经大量出血(HMB)率明显增加,而登记试验中并未发现这一现象。目前正在研究因子 XI(FXI)抑制剂,作为现有抗凝药物的另一种替代品。虽然遗传性 FXI 缺乏症的症状一般较轻,但其表型包括纤维蛋白溶解增强的组织出血,包括 HMB。因此,我们旨在对已发表的有关 FXI 抑制剂的研究进行系统回顾,以估计 HMB 的发生率。然而,我们发现纳入月经期患者的研究很少,专门报告子宫出血的研究更是少之又少,这再次凸显了我们在开展新型抗凝剂试验时存在的缺陷。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Journal of Thrombosis and Haemostasis
Journal of Thrombosis and Haemostasis 医学-外周血管病
CiteScore
24.30
自引率
3.80%
发文量
321
审稿时长
1 months
期刊介绍: The Journal of Thrombosis and Haemostasis (JTH) serves as the official journal of the International Society on Thrombosis and Haemostasis. It is dedicated to advancing science related to thrombosis, bleeding disorders, and vascular biology through the dissemination and exchange of information and ideas within the global research community. Types of Publications: The journal publishes a variety of content, including: Original research reports State-of-the-art reviews Brief reports Case reports Invited commentaries on publications in the Journal Forum articles Correspondence Announcements Scope of Contributions: Editors invite contributions from both fundamental and clinical domains. These include: Basic manuscripts on blood coagulation and fibrinolysis Studies on proteins and reactions related to thrombosis and haemostasis Research on blood platelets and their interactions with other biological systems, such as the vessel wall, blood cells, and invading organisms Clinical manuscripts covering various topics including venous thrombosis, arterial disease, hemophilia, bleeding disorders, and platelet diseases Clinical manuscripts may encompass etiology, diagnostics, prognosis, prevention, and treatment strategies.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信