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在伴有或不伴有 2 型糖尿病的心力衰竭患者中 SGLT-2 抑制剂的心血管结局:随机对照试验的系统评价和荟萃分析。

Cardiovascular Outcomes with SGLT-2 inhibitors in patients with heart failure with or without type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Diabetes & Endocrinology, G.D Hospital & Diabetes Institute, Kolkata, India.

出版信息

Diabetes Metab Syndr. 2021 Jan-Feb;15(1):351-359. doi: 10.1016/j.dsx.2021.01.006. Epub 2021 Jan 20.

DOI:10.1016/j.dsx.2021.01.006
PMID:33503584
Abstract

BACKGROUND AND AIMS

We conducted a systematic review and meta-analysis of all the randomized controlled trials (RCTs) with SGLT-2 inhibitors (SGLT-2i) in patients with known heart failure (HF) with or without type 2 diabetes (T2DM), that have studied the outcomes of cardiovascular (CV) death, hospitalization due to HF (HHF), and composite of CV death or HHF.

METHODS

A systematic search in PubMed, Embase and Cochrane Library database were made up till November 20, 2020 using specific keywords. RCTs that qualified underwent a meta-analysis by applying the inverse variance-weighted averages of pooled logarithmic hazard ratio (HR) using both random- and fixed-effects model.

RESULTS

This meta-analysis of 9 RCTs (N = 19,741) have found a significant 26% relative risk reduction in composite of CV death or HHF (HR 0.74; 95% CI, 0.69-0.79; p < 0.001) with SGLT-2i in patients with HF. The meta-analysis of 8 RCTs (N = 16,460) also showed a significant reduction in CV death (HR 0.86; 95% CI, 0.78-0.95; p = 0.003) and HHF (HR 0.68; 95% CI, 0.62-0.74; p < 0.001) outcomes with SGLT-2i in patients with HF. Subgroup analysis stratified on baseline ejection fraction (EF) showed a similar benefit in the composite of CV death or HHF in patients with HF with reduced EF (HFrEF) or preserved EF (HFpEF).

CONCLUSIONS

SGLT-2i significantly reduces the composite of CV death or HHF, CV death, and HHF in patients with HF. Although subgroup analysis suggested an insignificant P for these outcomes irrespective of the types of HF, however, reduction in both CV death and HHF were more pronounced in patients with HFrEF.

摘要

背景与目的

我们对所有使用 SGLT-2 抑制剂(SGLT-2i)治疗已知心力衰竭(HF)合并或不合并 2 型糖尿病(T2DM)患者的随机对照试验(RCT)进行了系统评价和荟萃分析,研究了心血管(CV)死亡、HF 住院(HHF)和 CV 死亡或 HHF 复合终点的结局。

方法

截至 2020 年 11 月 20 日,我们在 PubMed、Embase 和 Cochrane Library 数据库中使用特定关键词进行了系统搜索。符合条件的 RCT 采用逆方差加权平均对数风险比(HR)进行荟萃分析,随机和固定效应模型均适用。

结果

这项纳入 9 项 RCT(N=19741)的荟萃分析发现,HF 患者使用 SGLT-2i 可使 CV 死亡或 HHF 复合终点的相对风险降低 26%(HR 0.74;95%CI,0.69-0.79;p<0.001)。8 项 RCT(N=16460)的荟萃分析也显示,HF 患者使用 SGLT-2i 可显著降低 CV 死亡(HR 0.86;95%CI,0.78-0.95;p=0.003)和 HHF(HR 0.68;95%CI,0.62-0.74;p<0.001)结局。按基线射血分数(EF)分层的亚组分析显示,在 EF 降低(HFrEF)或 EF 保留(HFpEF)的 HF 患者中,CV 死亡或 HHF 复合终点有相似获益。

结论

SGLT-2i 可显著降低 HF 患者的 CV 死亡或 HHF、CV 死亡和 HHF 复合终点的发生率。尽管亚组分析提示无论 HF 类型如何,这些结局的 P 值均无统计学意义,但在 HFrEF 患者中,CV 死亡和 HHF 的降低更为明显。

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