TY - JOUR
T1 - Early Initiation of Sacubitril/Valsartan in Patients With Acute Heart Failure and Renal Dysfunction
T2 - An Analysis of the TRANSITION Study
AU - STRABURZYNSKA-MIGAJ, E. W.A.
AU - SENNI, M.
AU - WACHTER, R.
AU - FONSECA, C.
AU - WITTE, K. K.
AU - MUELLER, C.
AU - LONN, E.
AU - BUTYLIN, D.
AU - NOE, A.
AU - SCHWENDE, H.
AU - LAWRENCE, D.
AU - SURYAWANSHI, B.
AU - PASCUAL-FIGAL, D.
N1 - Funding Information:
This study was funded by Novartis .
Funding Information:
This study was funded by Novartis. The authors thank Tripti Sahu of Novartis Healthcare Pvt. Ltd. for providing medical writing support in accordance with Good Publication Practice (GPP 2022) guidelines (https://www.ismpp.org/gpp-2022).
Publisher Copyright:
© 2023 The Authors
PY - 2024/4
Y1 - 2024/4
N2 - 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 m2) 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.
AB - 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 m2) 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.
KW - Acute decompensated heart failure
KW - angiotensin receptor neprilysin inhibitor
KW - heart failure with reduced ejection fraction
KW - N-terminal-pro-B-type natriuretic peptide
KW - renal dysfunction
KW - sacubitril/valsartan
UR - http://www.scopus.com/inward/record.url?scp=85173153867&partnerID=8YFLogxK
U2 - 10.1016/j.cardfail.2023.08.021
DO - 10.1016/j.cardfail.2023.08.021
M3 - Article
C2 - 37678704
AN - SCOPUS:85173153867
SN - 1071-9164
VL - 30
SP - 425
EP - 435
JO - Journal of Cardiac Failure
JF - Journal of Cardiac Failure
IS - 3
ER -