Renal function dynamics following co-administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes.

Autores de INCLIVA

• 

  Rafael De La Espriella Juan

  Autor

• Enrique Santas Olmeda

  Autor

• Gema Miñana Escriva

  Autor

• 

  Juan Sanchis Fores

  Autor

• 

  Jose Luis Górriz Teruel

  Autor

• 

  Julio Nuñez Villota

  Autor

Participantes ajenos a INCLIVA

• Bayes-Genis, Antoni
• Morillas, Herminio
• Bravo, Rafael
• Vidal, Veronica
• Nunez, Eduardo
• Facila, Lorenzo
• Torres, Francisco
• Valle, Alfonso

Grupos y Plataformas de I+D+i

• Grupo de Enfermedad Renal

  

  Leading Researcher

  Jose Luis Górriz Teruel

• Grupo de investigación en Cardiología Clínica

  

  Leading Researcher

  Juan Sanchis Fores

• Grupo de Investigación en Insuficiencia Cardiaca

  

  Established Researcher

  Julio Nuñez Villota

Abstract

AIMS: 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).; METHODS AND RESULTS: 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=0.3mg/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±28mL/min/1.73m2 , respectively. At a median follow-up of 1.01years (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.; CONCLUSIONS: The co-administration of sacubitril/valsartan and empagliflozin in patients with HFrEF and concomitant T2D appears to be safe in terms of renal function. ©2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

©2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes

Keywords

• Heart failure with reduced ejection fraction (HFrEF); Type 2 diabetes mellitus; Sacubitril; valsartan; SGLT2i; Renal function; Renal safety profile