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达格列净对合并2型糖尿病的心力衰竭患者的影响:安慰剂对照随机试验的荟萃分析

The Effects of Dapagliflozin in Patients With Heart Failure Complicated With Type 2 Diabetes: A Meta-Analysis of Placebo-Controlled Randomized Trials.

作者信息

Zhai Miaobo, Du Xin, Liu Changmei, Xu Huipu

机构信息

Department of Cardiology, Affiliated Hospital of Binzhou Medical University, Binzhou, China.

出版信息

Front Clin Diabetes Healthc. 2021 Jun 30;2:703937. doi: 10.3389/fcdhc.2021.703937. eCollection 2021.

Abstract

BACKGROUND

Cardiovascular disease threatens the health and quality of life of individuals, particularly those with type II diabetes. Recently, some studies have reported the effect of sodium-glucose cotransporter 2 (SGLT2) inhibitors in reducing the rates of hospitalization or urgent visits, resulting in IV therapy for heart failure in patients with type 2 diabetes mellitus (T2DM).

METHODS

We did a comprehensive search in electronic databases from inception through July 2020 for randomized-controlled trials, using the keywords "sodium-glucose cotransporter-2 inhibitor", "dapagliflozin", "heart failure", "cardiovascular outcomes", "major adverse cardiovascular events", "all-cause mortality", and "cardiovascular death". Random-effects summary odds ratios (OR) were constructed using M-L heterogeneity model.

RESULTS

Five trials with 5,252 patients were ultimately included. The incidence of hospitalization for heart failure (HHF) (n=4, OR=0.74; 95% CI, 0.61 to 0.88; I = 0%) and all-cause mortality (ACM, n=4, OR=0.76; 95% CI, 0.66 to 0.94; I = 0%); was reduced by dapagliflozin, respectively, in all heart failure patients, without obvious heterogeneity. The incidence of cardiovascular death in dapagliflozin was lower than that in placebo without statistically significant (CVD, n=5, OR=0.84; 95% CI, 0.69 to 1.03; I = 0%). In HFrEF subgroup, dapagliflozin was associated with a reduced incidence of hospitalization for heart failure (n=4, OR=0.74; 95% CI, 0.60 to 0.91; I = 0%), cardiovascular death (n=4, OR=0.72; 95% CI, 0.58 to 0.91; I = 8%), and all-cause mortality (n=3, OR=0.70; 95% CI, 0.50 to 0.99; I = 43%) without significant heterogeneity. In contrast, in the HFpEF subgroup, there was no difference in the incidence of cardiovascular death (n=2, OR=1.45; 95% CI, 0.95 to 2.22; I = 0%) and all-cause mortality (n=2, OR=1.04; 95% CI, 0.76 to 1.43; I = 0%) between dapagliflozin and placebo.

CONCLUSION

In our study, dapagliflozin performed a statistical reduction in the rate of heart failure hospitalization, cardiovascular death, and all-cause mortality in patients with HFrEF and diabetes. However, in the HFpEF subgroup, dapagliflozin did not show a significant cardiovascular protective effect.

摘要

背景

心血管疾病威胁着个人的健康和生活质量,尤其是2型糖尿病患者。最近,一些研究报告了钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂在降低住院率或紧急就诊率方面的作用,从而为2型糖尿病(T2DM)患者的心力衰竭进行静脉治疗。

方法

我们从数据库建立至2020年7月在电子数据库中进行了全面检索,以查找随机对照试验,使用的关键词有“钠-葡萄糖协同转运蛋白-2抑制剂”、“达格列净”、“心力衰竭”、“心血管结局”、“主要不良心血管事件”、“全因死亡率”和“心血管死亡”。使用M-L异质性模型构建随机效应汇总比值比(OR)。

结果

最终纳入了5项试验,共5252例患者。在所有心力衰竭患者中,达格列净分别降低了心力衰竭住院率(HHF,n = 4,OR = 0.74;95% CI,0.61至0.88;I² = 0%)和全因死亡率(ACM,n = 4,OR = 0.76;95% CI,0.66至0.94;I² = 0%),且无明显异质性。达格列净组的心血管死亡率低于安慰剂组,但无统计学意义(CVD,n = 5,OR = 0.84;95% CI,0.69至1.03;I² = 0%)。在射血分数降低的心力衰竭(HFrEF)亚组中,达格列净与心力衰竭住院率降低(n = 4,OR = 0.74;95% CI,0.60至0.91;I² = 0%)、心血管死亡(n = 4,OR = 0.72;95% CI,0.58至0.91;I² = 8%)和全因死亡率降低(n = 3,OR = 0.70;95% CI,0.50至0.99;I² = 43%)相关,且无显著异质性。相比之下,在射血分数保留的心力衰竭(HFpEF)亚组中,达格列净与安慰剂组在心血管死亡率(n = 2,OR = 1.45;95% CI,0.95至2.22;I² = 0%)和全因死亡率(n = 2,OR = 1.04;95% CI,0.76至1.43;I² = 0%)方面无差异。

结论

在我们的研究中,达格列净在HFrEF合并糖尿病患者中使心力衰竭住院率、心血管死亡和全因死亡率有统计学意义的降低。然而,在HFpEF亚组中,达格列净未显示出显著的心血管保护作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f71f/10012068/cb175af88b00/fcdhc-02-703937-g001.jpg

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