Li Runmin, Dai Guohua, Guan Hui, Gao Wulin, Ren Lili, Wang Xingmeng, Qu Huiwen
First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, China.
Department of Geriatrics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
Front Cardiovasc Med. 2023 May 12;10:1143658. doi: 10.3389/fcvm.2023.1143658. eCollection 2023.
It remains controversial whether sodium-glucose cotransporter-2 inhibitors (SGLT-2is) are effective in treating heart failure with preserved ejection fraction (HFpEF).
The objective of this umbrella review is to provide a summary of the available evidence regarding the efficacy and safety of SGLT-2is for the treatment of HFpEF.
We extracted pertinent systematic reviews and meta-analyses (SRs/MAs) from PubMed, EMBASE, and the Cochrane Library that were published between the inception of the database and December 31, 2022. Two independent investigators assessed the methodological quality, risk of bias, report quality, and evidence quality of the included SRs/MAs in randomized controlled trials (RCTs). We further evaluated the overlap of the included RCTs by calculating the corrected covered area (CCA) and assessed the reliability of the effect size by performing excess significance tests. Additionally, the effect sizes of the outcomes were repooled to obtain objective and updated conclusions. Egger's test and sensitivity analysis were used to clarify the stability and reliability of the updated conclusion.
This umbrella review included 15 SRs/MAs, and their methodological quality, risk of bias, report quality, and evidence quality were unsatisfactory. The total CCA for 15 SRs/MAs was 23.53%, indicating a very high level of overlap. The excess significance tests did not reveal any significant results. Our updated MA demonstrated that the incidence of the composite of hospitalization for heart failure (HHF) or cardiovascular death (CVD), first HHF, total HHF, and adverse events as well as the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) and 6 min-walk distance (6MWD) were all substantially improved in the SGLT-2i intervention group compared to the control group. However, there was limited evidence that SGLT-2is could improve CVD, all-cause death, plasma B-type natriuretic peptide (BNP) level, or plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level. Egger's test and sensitivity analysis proved that the conclusion was stable and reliable.
SGLT-2 is a potential treatment for HFpEF with favourable safety. Given the dubious methodological quality, reporting quality, evidence quality, and high risk of bias for certain included SRs/MAs, this conclusion must be drawn with caution.
https://inplasy.com/, doi: 10.37766/inplasy2022.12.0083, identifier INPLASY2022120083.
钠-葡萄糖协同转运蛋白2抑制剂（SGLT-2i）在治疗射血分数保留的心力衰竭（HFpEF）方面是否有效仍存在争议。
本伞状综述的目的是总结关于SGLT-2i治疗HFpEF的疗效和安全性的现有证据。
我们从PubMed、EMBASE和Cochrane图书馆中提取了在数据库建立至2022年12月31日期间发表的相关系统评价和荟萃分析（SRs/MAs）。两名独立研究人员评估了纳入的SRs/MAs在随机对照试验（RCTs）中的方法学质量、偏倚风险、报告质量和证据质量。我们通过计算校正覆盖面积（CCA）进一步评估了纳入的RCTs的重叠情况，并通过进行过剩显著性检验评估了效应大小的可靠性。此外，对结局的效应大小进行重新合并以获得客观和更新的结论。使用Egger检验和敏感性分析来阐明更新结论的稳定性和可靠性。
本伞状综述纳入了15项SRs/MAs，它们的方法学质量、偏倚风险、报告质量和证据质量均不令人满意。15项SRs/MAs的总CCA为23.53%，表明重叠程度非常高。过剩显著性检验未显示任何显著结果。我们更新的荟萃分析表明，与对照组相比，SGLT-2i干预组中心力衰竭住院（HHF）或心血管死亡（CVD）的复合事件、首次HHF、总HHF、不良事件以及堪萨斯城心肌病问卷总症状评分（KCCQ-TSS）和6分钟步行距离（6MWD）的发生率均有显著改善。然而，仅有有限的证据表明SGLT-2i可改善CVD、全因死亡、血浆B型利钠肽（BNP）水平或血浆N末端B型利钠肽原（NT-proBNP）水平。Egger检验和敏感性分析证明结论是稳定可靠的。
SGLT-2i是一种治疗HFpEF的潜在疗法，安全性良好。鉴于某些纳入的SRs/MAs的方法学质量、报告质量、证据质量存疑且偏倚风险高，得出这一结论时必须谨慎。
https://inplasy.com/，doi: 10.37766/inplasy2022.12.0083，标识符INPLASY2022120083 。
