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钠-葡萄糖共转运蛋白 2 抑制剂在 2 型糖尿病中的应用:临床试验对心力衰竭的获益是否反映在真实世界的临床实践中?一项观察性研究的系统评价和荟萃分析。

Sodium-glucose co-transporter-2 inhibitors in type 2 diabetes: Are clinical trial benefits for heart failure reflected in real-world clinical practice? A systematic review and meta-analysis of observational studies.

机构信息

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

Department of Clinical and Experimental Medicine, University of Surrey, Guildford, UK.

出版信息

Diabetes Obes Metab. 2023 Feb;25(2):501-515. doi: 10.1111/dom.14893. Epub 2022 Nov 2.

DOI:10.1111/dom.14893
PMID:36239122
Abstract

AIM

To determine the absolute risk reduction (ARR) of heart failure events in people treated with sodium-glucose co-transporter-2 (SGLT2) inhibitors.

MATERIALS AND METHODS

We searched PubMed, EMBASE, CINAHL and ISI Web of Science for observational studies published to 9 May 2022 that explored the association between SGLT2 inhibitors and any indication for heart failure (including new diagnosis or hospitalization for heart failure) in type 2 diabetes. Identified studies were independently screened by two reviewers and assessed for bias using the Newcastle-Ottawa scale. Eligible studies with comparable outcome data were pooled for meta-analysis using random-effects models, reporting hazard ratios (HRs) with 95% confidence intervals (CIs). The ARR per 100 person-years was determined overall, and in subgroups with and without baseline cardiovascular disease (CVD).

RESULTS

From 43 eligible studies, with a total of 4 818 242 participants from 17 countries, 21 were included for meta-analysis. SGLT2 inhibitors were associated with a reduced risk of hospitalization for heart failure (HR 0.65, 95% CI 0.59-0.72) overall and both in those with CVD (HR 0.78, 95% CI 0.68-0.89) and without CVD (HR 0.53, 95% CI 0.39-0.71). Risk reduction for hospitalization for heart failure in people with a history of CVD (ARR 1.17, 95% CI 0.78-1.55) was significantly greater than for those without CVD (ARR 0.39, 95% CI 0.32-0.47). The number-needed-to-treat to prevent one event of hospitalization for heart failure was 86 (95% CI 65-128) person-years of treatment for the CVD group and 256 (95% CI 215-316) person-years for those without CVD.

CONCLUSIONS

Real-world SGLT2 inhibitor use supports randomized trial data for the size effect of reduced hospitalization for heart failure in type 2 diabetes, although with a much lower ARR in people without CVD.

摘要

目的

确定钠-葡萄糖共转运蛋白 2(SGLT2)抑制剂治疗人群中心力衰竭事件的绝对风险降低(ARR)。

材料和方法

我们检索了 PubMed、EMBASE、CINAHL 和 ISI Web of Science,以查找截至 2022 年 5 月 9 日发表的观察性研究,这些研究探讨了 SGLT2 抑制剂与 2 型糖尿病中任何心力衰竭指征(包括心力衰竭的新诊断或住院治疗)之间的关联。两名评审员独立筛选确定的研究,并使用纽卡斯尔-渥太华量表评估偏倚。对具有可比结局数据的合格研究进行荟萃分析,采用随机效应模型,报告风险比(HR)及其 95%置信区间(CI)。总体上以及在基线时无或有心血管疾病(CVD)的亚组中,确定每 100 人年的 ARR。

结果

从来自 17 个国家的 43 项合格研究中,共有 4818242 名参与者,其中 21 项研究纳入荟萃分析。总体上以及在有 CVD(HR 0.78,95%CI 0.68-0.89)和无 CVD(HR 0.53,95%CI 0.39-0.71)的患者中,SGLT2 抑制剂与心力衰竭住院风险降低相关。有 CVD 病史的患者因心力衰竭住院的风险降低(ARR 1.17,95%CI 0.78-1.55)显著大于无 CVD 患者(ARR 0.39,95%CI 0.32-0.47)。预防心力衰竭住院的事件需要治疗的人数(NNT)在有 CVD 组为 86(95%CI 65-128)人年,在无 CVD 组为 256(95%CI 215-316)人年。

结论

真实世界 SGLT2 抑制剂的应用支持随机试验数据表明,2 型糖尿病患者因心力衰竭住院的风险降低幅度较大,尽管无 CVD 患者的 ARR 要低得多。

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