达帕格列净对终末期肾病心血管的影响(DARE-ESKD-2)试验:原理与设计。

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Expert Opinion on Drug Safety Pub Date : 2024-10-13 DOI:10.1080/14740338.2024.2412228
Joaquim Barreto, Marilia Martins, Mauro Pascoa, Sheila T K Medorima, Isabella Bonilha, Daniel Campos Jesus, Cinthia E M Carbonara, Kelcia R S Quadros, Barbara Assato, Alessandra M Campos-Staffico, Gil Guerra Júnior, Wilson Nadruz, Rodrigo B de Oliveira, Andrei C Sposito
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引用次数: 0

摘要

背景:达帕格列净可预防慢性肾脏病患者的心肌功能障碍,而与残余肾功能无关,我们假设这种效果也可扩展至透析患者:DARE-ESKD-2是一项正在进行的单中心、开放标签随机临床试验,旨在确定在标准治疗的基础上添加达帕格列净对心肌功能和结构的影响。符合条件的患者为接受常规透析治疗 3 个月以上的成人。妊娠、肝功能衰竭、对研究药物过敏以及曾使用过 SGLT2i 均为排除标准。参与者按 1:1 的比例随机分配到达帕格列净或标准治疗组,为期 24 周。主要目标是比较研究组间 NT-proBNP 水平的变化,次要目标包括比较组间左心室整体纵向应变、指数质量、射血分数和 E/e` 比值以及症状量表和 6 分钟步行测试距离的差异。一项探索性分析将评估身体成分和骨密度测量的变化:结果:该试验已完成 80 名患者的注册,目前正在随访中:该试验将为透析患者服用 SGLT2i 对心肌的影响提供新数据。这项研究的结果可为 SGLT2i 在 ESKD 中的应用提供支持证据。
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Dapagliflozin cardiovascular effects on end-stage kidney disease (DARE-ESKD-2) trial: rationale and design.

Background: Dapagliflozin prevents myocardial dysfunction in chronic kidney disease patients regardless of residual kidney function. We hypothesized that this effect is extensible also to patients on dialysis.

Research design and methods: The DARE-ESKD-2 is an ongoing, single-center, open-label randomized clinical trial designed to determine the effects of adding dapagliflozin to standard treatment on myocardial function and structure. Eligible patients were adults on a regular dialysis scheme for more than 3 months. Pregnancy, liver failure, allergy to the investigational drug, and prior use of SGLT2i were exclusion criteria. Participants were randomized in a 1:1 ratio to dapagliflozin or standard treatment groups for 24-weeks. The primary goal is to compare the change in NT-proBNP levels between study arms, and secondary goals include comparing the between-group difference in left ventricle global longitudinal strain, indexed mass, ejection fraction, and E/e` ratio, and on symptoms scale and 6-minute walk test distance. An exploratory analysis will evaluate changes in body composition and bone densitometry.

Results: The trial has finished the enrollment of 80 patients, who are currently being followed-up.

Conclusions: This trial will provide novel data on myocardial effects of SGLT2i in dialysis recipients. Results from this study may provide evidence to support SGLT2i use in ESKD.

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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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