Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes
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 multic...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2020-12-01
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| Series: | ESC Heart Failure |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/ehf2.12965 |
| _version_ | 1818683100038692864 |
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| author | Rafael de laEspriella Antoni Bayés‐Genís Herminio Morillas Rafael Bravo Verónica Vidal Eduardo Núñez Enrique Santas Gema Miñana Juan Sanchis Lorenzo Fácila Francisco Torres Jose Luis Górriz Alfonso Valle Julio Núñez |
| author_facet | Rafael de laEspriella Antoni Bayés‐Genís Herminio Morillas Rafael Bravo Verónica Vidal Eduardo Núñez Enrique Santas Gema Miñana Juan Sanchis Lorenzo Fácila Francisco Torres Jose Luis Górriz Alfonso Valle Julio Núñez |
| author_sort | Rafael de laEspriella |
| collection | DOAJ |
| description | 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 ≥ 0.3 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 m2, 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. 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. |
| first_indexed | 2024-12-17T10:29:22Z |
| format | Article |
| id | doaj.art-8ea7742647c84b168f0531ea5ff86ac0 |
| institution | Directory Open Access Journal |
| issn | 2055-5822 |
| language | English |
| last_indexed | 2024-12-17T10:29:22Z |
| publishDate | 2020-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj.art-8ea7742647c84b168f0531ea5ff86ac02022-12-21T21:52:34ZengWileyESC Heart Failure2055-58222020-12-01763792380010.1002/ehf2.12965Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetesRafael de laEspriella0Antoni Bayés‐Genís1Herminio Morillas2Rafael Bravo3Verónica Vidal4Eduardo Núñez5Enrique Santas6Gema Miñana7Juan Sanchis8Lorenzo Fácila9Francisco Torres10Jose Luis Górriz11Alfonso Valle12Julio Núñez13Cardiology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina Universitat de València Valencia SpainCIBER in Cardiovascular Diseases (CIBERCV) Madrid SpainCardiology Department Hospital de Dénia‐MarinaSalud Dénia SpainCardiology Department Hospital Costa del Sol Marbella SpainCardiology Department Hospital General de Valencia Valencia SpainCardiology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina Universitat de València Valencia SpainCardiology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina Universitat de València Valencia SpainCardiology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina Universitat de València Valencia SpainCardiology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina Universitat de València Valencia SpainCardiology Department Hospital General de Valencia Valencia SpainCardiology Department Hospital de Dénia‐MarinaSalud Dénia SpainNephrology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina Universitat de València Valencia SpainCardiology Department Hospital de Dénia‐MarinaSalud Dénia SpainCardiology Department, Hospital Clínico Universitario de Valencia, INCLIVA, Departamento de Medicina Universitat de València Valencia SpainAbstract 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 ≥ 0.3 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 m2, 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. 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.https://doi.org/10.1002/ehf2.12965Heart failure with reduced ejection fraction (HFrEF)Type 2 diabetes mellitusSacubitril/valsartanSGLT2iRenal functionRenal safety profile |
| spellingShingle | Rafael de laEspriella Antoni Bayés‐Genís Herminio Morillas Rafael Bravo Verónica Vidal Eduardo Núñez Enrique Santas Gema Miñana Juan Sanchis Lorenzo Fácila Francisco Torres Jose Luis Górriz Alfonso Valle Julio Núñez Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes ESC Heart Failure Heart failure with reduced ejection fraction (HFrEF) Type 2 diabetes mellitus Sacubitril/valsartan SGLT2i Renal function Renal safety profile |
| title | Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes |
| title_full | Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes |
| title_fullStr | Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes |
| title_full_unstemmed | Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes |
| title_short | Renal function dynamics following co‐administration of sacubitril/valsartan and empagliflozin in patients with heart failure and type 2 diabetes |
| title_sort | renal function dynamics following co administration of sacubitril valsartan and empagliflozin in patients with heart failure and type 2 diabetes |
| topic | Heart failure with reduced ejection fraction (HFrEF) Type 2 diabetes mellitus Sacubitril/valsartan SGLT2i Renal function Renal safety profile |
| url | https://doi.org/10.1002/ehf2.12965 |
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