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达格列净用于急性心力衰竭管理:安全性与有效性的系统评价和荟萃分析

Dapagliflozin in acute heart failure management: a systematic review and meta-analysis of safety and effectiveness.

作者信息

Raja Adarsh, Dogar Mata-E-Alla, Raja Sandesh, Shuja Muhammad Hamza, Amin Shafin Bin, Khelani Muskan, Fatima Urooj, Soomro Aiman, Habiba Ayesha, Mustafa Iqra, Zulfiqar Rakhshan, Asghar Muhammad Sohaib

机构信息

Department of Medicine, Shaheed Mohtarma Benazir Bhutto Medical College Lyari, Karachi, Pakistan.

Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan.

出版信息

BMC Cardiovasc Disord. 2024 Dec 28;24(1):749. doi: 10.1186/s12872-024-04412-x.

DOI:10.1186/s12872-024-04412-x
PMID:39731023
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11681638/
Abstract

BACKGROUND

Acute Heart Failure (AHF) presents as a serious pathophysiological disease with significant morbidity and mortality rates, requiring immediate medical intervention. Traditional treatment involves diuretics and vasodilators, but a subset of patients develop resistance due to acute cardiorenal syndrome. Dapagliflozin, categorized as a sodium-glucose cotransporter-2 inhibitor (SGLT2i), has emerged as a promising therapy for AHF, demonstrating substantial benefits in reducing both mortality and morbidity among patients. The purpose of this meta-analysis and systematic review is to determine dapagliflozin's safety and efficacy in AHF patients.

METHODS

In accordance with PRISMA guidelines, we conducted a systematic search across several databases (PubMed, Science Direct, and Cochrane Library) up to June 2024 to identify randomized controlled trials (RCTs) that compared dapagliflozin with control treatments in patients with AHF. Key outcomes of interest included In-Hospital Cardiovascular mortality rates, duration of hospitalization, and instances of in-hospital worsening. Data extraction and quality assessment adhered to established protocols and the results were evaluated using Review Manager (RevMan Version 5.4.1) The assessment of bias risk follows the principles established in the Cochrane Handbook for Systematic Reviews and Meta-Analysis.

RESULTS

Five RCTs comprising 912 patients met the inclusion criteria. Dapagliflozin significantly reduced In-Hospital Cardiovascular mortality (RR 0.56, 95% CI 0.36-0.88, p = 0.01, I²=26%) and 30-day hospital readmissions (RR 0.73, CI 0.54-0.99, p = 0.05, I²=7%). However, dapagliflozin did not significantly affect the length of hospital stay (MD -0.11, CI -0.73-0.51, p = 0.72, I²=60%) or the incidence of hypotension (RR 0.82, CI 0.36-1.84, p = 0.63, I²=0%). A significant weight change was observed (MD 0.93, CI 0.03-1.83, p = 0.04, I²=95%), which was resolved upon sensitivity analysis (MD 1.34, CI 1.02-1.66, p < 0.0001, I²=0%). No significant effects were found for worsening renal failure or changes in GFR in this study.

CONCLUSION

Dapagliflozin appears to be beneficial in reducing In-Hospital Cardiovascular mortality and 30-day hospital readmissions in AHF patients. Although it demonstrates potential, additional research is needed to establish its significance in AHF management. Further investigation with larger sample sizes, different doses, and comprehensive safety and cost-effectiveness is imperative to thoroughly evaluate the safety and clinical efficacy of Dapagliflozin, underscoring the necessity for additional data to substantiate its role in managing patients with AHF.

CLINICAL TRIAL NUMBER

Not applicable.

摘要

背景

急性心力衰竭(AHF)是一种严重的病理生理疾病,发病率和死亡率都很高,需要立即进行医学干预。传统治疗方法包括使用利尿剂和血管扩张剂,但一部分患者由于急性心肾综合征而产生耐药性。达格列净属于钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i),已成为治疗AHF的一种有前景的疗法,在降低患者死亡率和发病率方面显示出显著益处。本荟萃分析和系统评价的目的是确定达格列净在AHF患者中的安全性和疗效。

方法

根据PRISMA指南,我们截至2024年6月对多个数据库(PubMed、Science Direct和Cochrane图书馆)进行了系统检索,以识别比较达格列净与对照治疗对AHF患者疗效的随机对照试验(RCT)。感兴趣的主要结局包括住院期间心血管死亡率、住院时间和住院期间病情恶化情况。数据提取和质量评估遵循既定方案,并使用Review Manager(RevMan版本5.4.1)对结果进行评估。偏倚风险评估遵循Cochrane系统评价和荟萃分析手册中确立的原则。

结果

五项RCT共纳入912例患者,符合纳入标准。达格列净显著降低了住院期间心血管死亡率(风险比RR 0.56,95%置信区间CI 0.36 - 0.88,p = 0.01,I² = 26%)和30天内再入院率(RR 0.73,CI 0.54 - 0.99,p = 0.05,I² = 7%)。然而,达格列净对住院时间(平均差MD -0.11,CI -0.73 - 0.51,p = 0.72,I² = 60%)或低血压发生率(RR 0.82,CI 0.36 - 1.84,p = 0.63,I² = 0%)没有显著影响。观察到体重有显著变化(MD 0.93,CI 0.03 - 1.83,p = 0.04,I² = 95%),但敏感性分析后该变化得到解决(MD 1.34,CI 1.02 - 1.66,p < 0.0001,I² = 0%)。本研究中未发现达格列净对肾功能恶化或肾小球滤过率变化有显著影响。

结论

达格列净似乎有助于降低AHF患者的住院期间心血管死亡率和30天内再入院率。尽管它显示出一定潜力,但仍需要更多研究来确定其在AHF治疗中的重要性。必须进行更大样本量、不同剂量以及全面安全性和成本效益的进一步研究,以彻底评估达格列净的安全性和临床疗效,强调需要更多数据来证实其在AHF患者管理中的作用。

临床试验编号

不适用。

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