1. Early Initiation of Sacubitril/Valsartan in Patients With Acute Heart Failure and Renal Dysfunction: An Analysis of the TRANSITION Study.
- Author
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Straburzynska-Migaj E, Senni M, Wachter R, Fonseca C, Witte KK, Mueller C, Lonn E, Butylin D, Noe A, Schwende H, Lawrence D, Suryawanshi B, and Pascual-Figal D
- Subjects
- Humans, Aminobutyrates adverse effects, Angiotensin Receptor Antagonists, Biomarkers, Biphenyl Compounds, Drug Combinations, Stroke Volume, Tetrazoles adverse effects, Treatment Outcome, Valsartan, Heart Failure, Kidney Diseases, Ventricular Dysfunction, Left drug therapy
- Abstract
Background: Treatment of patients with heart failure with reduced ejection fraction (HFrEF) and renal dysfunction (RD) is challenging owing to the risk of further deterioration in renal function, especially after acute decompensated HF (ADHF)., Methods and Results: We assessed the effect of RD (estimated glomerular filtration rate of ≥30 to <60 mL/min/1.73 m
2 ) on initiation, up-titration, and tolerability of sacubitril/valsartan in hemodynamically stabilized patients with HFrEF admitted for ADHF (RD, n = 476; non-RD, n = 483). At week 10, the target dose of sacubitril/valsartan (97/103 mg twice daily) was achieved by 42% patients in RD subgroup vs 54% in non-RD patients (P < .001). Sacubitril/valsartan was associated with greater estimated glomerular filtration rate improvements in RD subgroup than non-RD (change from baseline least squares mean 4.1 mL/min/1.73 m2 , 95% confidence interval 2.2-6.1, P < .001). Cardiac biomarkers improved significantly in both subgroups; however, compared with the RD subgroup, the improvement was greater in those without RD (N-terminal pro-brain natriuretic peptide, -28.6% vs -44.8%, high-sensitivity troponin T -20.3% vs -33.9%) (P < .001). Patients in the RD subgroup compared with those without RD experienced higher rates of hyperkalemia (16.3% vs 6.5%, P < .001), investigator-reported cardiac failure (9.7% vs 5.6%, P = .029), and renal impairment (6.4% vs 2.1%, P = .002)., Conclusions: Most patients with HFrEF and concomitant RD hospitalized for ADHF tolerated early initiation of sacubitril/valsartan and showed significant improvements in estimated glomerular filtration rate and cardiac biomarkers., Clinical Trial Registration: NCT02661217., Competing Interests: Declaration of Competing Interest E. Straburzynska-Migaj received consultancy fees and/or honoraria from Novartis, Boehringer Ingelheim, Pfizer, Abbott, Servier, AstraZeneca, and Bausch Health. M. Senni received consultancy fees and/or speaker's honoraria from Novartis, Bayer, Abbott, Merck, AstraZeneca, Vifor Pharma, and Boehringer Ingelheim. R. Wachter is a member of advisory boards and/or received speaker's honoraria from Boehringer Ingelheim, Bayer, CVRx, Medtronic, Novartis, Pfizer, Sanofi, and Servier, and research grants from Boehringer Ingelheim, European Union, and Bundesministerium für Bildung und Forschung. C. Fonseca received consultancy fees, grants and speaker's honoraria from Astra Zeneca, Bayer, Boehringer Ingelheim, Novartis, Roche, Sanofi, Servier, and Vifor Pharma. K. K. Witte was the UK Principal Investigator on the TRANSITION study. He has received research support in the form of a PhD fellowship program to the University of Leeds from Medtronic UK, the MRC, and Heart Research UK, and holds fellowship grants from the NIHR and the British Heart Foundation. He has received consultancy and/or speaker fees from Medtronic, Abbott, Microport, Boehringer Ingelheim, Bayer, Novartis, and Astra Zeneca. C. Mueller has received research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, the KTI, the European Union, the University Basel, the University Hospital Basel, Abbott, Astra Zeneca, Beckman Coulter, BRAHMS, Idorsia, Novartis, Ortho Clinical Diagnostics, Quidel, Roche, Siemens, Singulex, and Sphingotec, as well as speaker/consulting honoraria from Astra Zeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, Idorsia, Osler, Novartis, Roche, Sanofi, Siemens, and Singulex, all outside the current work and all paid to the institution. E. Lonn received research support from Novartis, Boehringer Ingelheim, Bayer, AstraZeneca, Amgen, Sanofi, and Roche, and consultancy fees and/or speaker's honoraria from Novartis, Amgen, Bayer, Boehringer Ingelheim, and Sanofi. D. Butylin, A. Noe, H. Schwende and D. Lawrence are employees of Novartis. B. Suryawanshi is an employee of IQVIA, India. D. Pascual-Figal declares research grants from Roche, Novartis, AstraZeneca, Medtronic, and Pfizer; and consultancy or educational honoraria from AstraZeneca, Novartis, Servier, Pfizer, Vifor Pharma, Rovi, and Abbott., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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