de la Espriella Rafael, Bayés-Genís Antoni, Morillas Herminio, Bravo Rafael, Vidal Verónica, Núñez Eduardo, Santas Enrique, Miñana Gema, Sanchis Juan, Fácila Lorenzo, Torres Francisco, Górriz Jose Luis, Valle Alfonso, Núñez Julio
Cardiology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina, Universitat de València, Valencia, Spain.
CIBER in Cardiovascular Diseases (CIBERCV), Madrid, Spain.
ESC Heart Fail. 2020 Dec;7(6):3792-3800. doi: 10.1002/ehf2.12965. Epub 2020 Sep 22.
The aim of this study was to evaluate the safety profile in terms of changes in renal function after co-treatment with sacubitril/valsartan and empagliflozin in patients with type 2 diabetes (T2D) and heart failure with reduced ejection fraction (HFrEF).
This multicentre observational analysis included 108 patients with T2D and HFrEF treated with both agents: baseline sacubitril/valsartan (Group A; n = 43), baseline empagliflozin (Group B; n = 42), or both agents initiated simultaneously (Group C; n = 23). The primary endpoint was estimated glomerular filtration rate (eGFR) dynamics across treatment groups. A binary characterization of worsening renal function (WRF)/improved renal function (IRF) was included in the primary endpoint. WRF and IRF were defined as an increase/decrease in serum creatinine ≥ 0.3 mg/dL or GFR ≥ 20%. Changes in quantitative variables were evaluated using joint modelling of survival and longitudinal data (JM). Rates and their treatment differences were determined by Poisson regression. The mean left ventricle ejection fraction and eGFR were 32 ± 6% and 70 ± 28 mL/min/1.73 m , respectively. At a median follow-up of 1.01 years (inter-quartile range 0.71-1.50), 377 outpatient visits were recorded. Although there were differences in GFR trajectories over time within each treatment, they did not achieve statistical significance (omnibus P = 0.154). However, when these differences were contrasted among groups, there was a significant decrease in GFR in Group A as compared with Group B (P = 0.002). The contrast between Groups C and B was not significant (P = 0.430). These differences were also reflected when the rates for WRF and IRF were contrasted among treatments.
The co-administration of sacubitril/valsartan and empagliflozin in patients with HFrEF and concomitant T2D appears to be safe in terms of renal function.
本研究旨在评估在射血分数降低的心力衰竭（HFrEF）合并2型糖尿病（T2D）患者中，沙库巴曲缬沙坦与恩格列净联合治疗后肾功能变化方面的安全性。
这项多中心观察性分析纳入了108例接受两种药物治疗的T2D和HFrEF患者：基线使用沙库巴曲缬沙坦（A组；n = 43）、基线使用恩格列净（B组；n = 42）或两种药物同时起始治疗（C组；n = 23）。主要终点是各治疗组间的估计肾小球滤过率（eGFR）动态变化。主要终点纳入了肾功能恶化（WRF）/肾功能改善（IRF）的二元特征。WRF和IRF定义为血清肌酐升高/降低≥0.3mg/dL或肾小球滤过率（GFR）≥20%。使用生存和纵向数据联合建模（JM）评估定量变量的变化。通过泊松回归确定发生率及其治疗差异。平均左心室射血分数和eGFR分别为32±6%和70±28mL/min/1.73m²。在中位随访1.01年（四分位间距0.71 - 1.50）时，记录了377次门诊就诊情况。尽管各治疗组内GFR随时间的轨迹存在差异，但未达到统计学显著性（总体P = 0.154）。然而，当在组间对比这些差异时，A组的GFR较B组显著降低（P = 0.002）。C组与B组之间的对比无显著性（P = 0.430）。当对比各治疗组的WRF和IRF发生率时，也反映出了这些差异。
在HFrEF合并T2D患者中，沙库巴曲缬沙坦与恩格列净联合给药在肾功能方面似乎是安全的。
