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恩格列净对 2 型糖尿病患者右心室参数和功能的影响。

Impact of empagliflozin on right ventricular parameters and function among patients with type 2 diabetes.

机构信息

Division of Cardiology, Terrence Donnelly Heart Centre, St Michael's Hospital, 30 Bond Street, Toronto, ON, M5B 1W8, Canada.

University of Toronto, Toronto, Canada.

出版信息

Cardiovasc Diabetol. 2021 Oct 4;20(1):200. doi: 10.1186/s12933-021-01390-8.

Abstract

BACKGROUND

Sodium-glucose cotransporter 2 (SGLT2) inhibition reduces cardiovascular events in type 2 diabetes (T2DM) and is associated with a reduction in left ventricular (LV) mass index. However, the impact on right ventricular (RV) remodeling is unknown. Accordingly, the objective of this study was to assess the impact of SGLT2 inhibition on RV parameters and function in T2DM and coronary artery disease (CAD).

METHODS

In EMPA-HEART CardioLink-6, 97 patients with T2DM and CAD were randomly assigned to empagliflozin 10 mg (n = 49) once daily or placebo (n = 48). Cardiac magnetic resonance imaging was performed at baseline and after 6 months. RV mass index (RVMi), RV end-diastolic and end-systolic volume index (RVEDVi, RVESVi) and RV ejection fraction (RVEF) were assessed in blinded fashion.

RESULTS

At baseline, mean RVMi (± SD) (11.8 ± 2.4 g/m), RVEF (53.5 ± 4.8%), RVEDVi (64.3 ± 13.2 mL/m) and RVESVi (29.9 ± 6.9 mL/m) were within normal limits and were similar between the empagliflozin and placebo groups. Over 6 months, there were no significant differences in RVMi (- 0.11 g/m, [95% CI - 0.81 to 0.60], p = 0.76), RVEF (0.54%, [95% CI - 1.4 to 2.4], p = 0.58), RVEDVi (- 1.2 mL/m, [95% CI - 4.1 to 1.7], p = 0.41) and RVESVi (- 0.81 mL/m, [95% CI - 2.5 to 0.90], p = 0.35) in the empaglifozin group as compared with the placebo group. In both groups, there was no significant correlation between RVMi and LVMi changes from baseline to 6 months.

CONCLUSIONS

In this post-hoc analysis, SGLT2 inhibition with empagliflozin had no impact on RVMi and RV volumes in patients with T2DM and CAD. The potentially differential effect of empagliflozin on the LV and RV warrants further investigation.

CLINICAL TRIAL REGISTRATION

URL:  https://www.clinicaltrials.gov/ct2/show/NCT02998970?cond=NCT02998970&draw=2&rank=1 . Unique identifier: NCT02998970.

摘要

背景

钠-葡萄糖协同转运蛋白 2(SGLT2)抑制剂可降低 2 型糖尿病(T2DM)患者的心血管事件发生率,并与左心室(LV)质量指数降低相关。然而,其对右心室(RV)重构的影响尚不清楚。因此,本研究旨在评估 SGLT2 抑制剂对 T2DM 和冠心病(CAD)患者 RV 参数和功能的影响。

方法

在 EMPA-HEART CardioLink-6 中,97 例 T2DM 和 CAD 患者被随机分为恩格列净 10mg 组(n=49)和安慰剂组(n=48),每日一次。在基线和 6 个月时进行心脏磁共振成像检查。以盲法评估 RV 质量指数(RVMi)、RV 舒张末期和收缩末期容积指数(RVEDVi、RVESVi)和 RV 射血分数(RVEF)。

结果

基线时,平均 RVMi(±SD)(11.8±2.4g/m)、RVEF(53.5±4.8%)、RVEDVi(64.3±13.2mL/m)和 RVESVi(29.9±6.9mL/m)均在正常范围内,且恩格列净组和安慰剂组间无显著差异。6 个月时,RVMi 无显著变化(-0.11g/m,[95%CI-0.81 至 0.60],p=0.76)、RVEF 无显著变化(0.54%,[95%CI-1.4 至 2.4],p=0.58)、RVEDVi 无显著变化(-1.2mL/m,[95%CI-4.1 至 1.7],p=0.41)和 RVESVi 无显著变化(-0.81mL/m,[95%CI-2.5 至 0.90],p=0.35),与安慰剂组相比,恩格列净组差异均无统计学意义。两组中,基线至 6 个月时 RVMi 与 LVMi 的变化之间均无显著相关性。

结论

本事后分析显示,SGLT2 抑制剂恩格列净对 T2DM 和 CAD 患者的 RVMi 和 RV 容积无影响。恩格列净对 LV 和 RV 的潜在不同影响值得进一步研究。

临床试验注册

网址:https://www.clinicaltrials.gov/ct2/show/NCT02998970?cond=NCT02998970&draw=2&rank=1。唯一标识符:NCT02998970。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/447f/8491405/cf6259755826/12933_2021_1390_Fig1_HTML.jpg

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