Sacubitril-valsartan vs ACE/ARB in pediatric heart failure: A retrospective cohort study.
Humans
Aminobutyrates
/ therapeutic use
Biphenyl Compounds
/ therapeutic use
Drug Combinations
Retrospective Studies
Heart Failure
/ drug therapy
Valsartan
/ therapeutic use
Male
Female
Child
Angiotensin Receptor Antagonists
/ therapeutic use
Tetrazoles
/ therapeutic use
Child, Preschool
Adolescent
Angiotensin-Converting Enzyme Inhibitors
/ therapeutic use
Infant
Treatment Outcome
Heart Transplantation
Propensity Score
congenital heart disease
entresto
heart transplantation
pediatric heart failure
sacubitril-valsartan
Journal
The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation
ISSN: 1557-3117
Titre abrégé: J Heart Lung Transplant
Pays: United States
ID NLM: 9102703
Informations de publication
Date de publication:
May 2024
May 2024
Historique:
received:
13
09
2023
revised:
18
01
2024
accepted:
22
01
2024
medline:
6
5
2024
pubmed:
6
5
2024
entrez:
5
5
2024
Statut:
ppublish
Résumé
The first angiotensin receptor/neprilysin inhibitor on the market, sacubitril-valsartan, has shown marked improvements in death and hospitalization for heart failure among adults, and is now approved for use in pediatric heart failure. While the ongoing PANORAMA-HF trial is evaluating the effectiveness of sacubitril-valsartan for pediatric patients with a failing systemic left ventricle, the enrollment criteria do not include the majority of pediatric heart failure patients. Additional studies are needed. Using the TriNetX database, we performed a propensity score matched, retrospective cohort study to assess the incidence of a composite of all-cause mortality or heart transplant within 1 year. The 519 patients who received sacubitril-valsartan were compared to 519 matched controls who received an angiotensin converting enzyme inhibitor (ACE) or angiotensin II receptor blocker (ARB). There was no significant difference in the incidence of the composite outcome with sacubitril-valsartan over an ACE/ARB (13.3% vs 13.2%, p = 0.95), or among the components of mortality (5.0% vs 5.8%, p = 0.58) or heart transplantation (8.7% vs 7.5%, p = 0.50). Patients who were receiving full goal-directed medical therapy (14.4% vs 16.0%, p = 0.55) also showed no difference in the composite outcome. We observed a significantly increased incidence of hypotension (10% vs 5.2%, p = 0.006) and a trend toward reduced number of hospitalizations per year (mean (SD) 1.3 (4.4) vs 2.0 (9.1), p = 0.09). Sacubitril-valsartan is not associated with a decrease in the composite of all-cause mortality or heart transplantation within 1 year. Future studies should evaluate the possible reduction in hospitalizations and optimal dosing to minimize hypotension.
Sections du résumé
BACKGROUND
BACKGROUND
The first angiotensin receptor/neprilysin inhibitor on the market, sacubitril-valsartan, has shown marked improvements in death and hospitalization for heart failure among adults, and is now approved for use in pediatric heart failure. While the ongoing PANORAMA-HF trial is evaluating the effectiveness of sacubitril-valsartan for pediatric patients with a failing systemic left ventricle, the enrollment criteria do not include the majority of pediatric heart failure patients. Additional studies are needed.
METHODS
METHODS
Using the TriNetX database, we performed a propensity score matched, retrospective cohort study to assess the incidence of a composite of all-cause mortality or heart transplant within 1 year. The 519 patients who received sacubitril-valsartan were compared to 519 matched controls who received an angiotensin converting enzyme inhibitor (ACE) or angiotensin II receptor blocker (ARB).
RESULTS
RESULTS
There was no significant difference in the incidence of the composite outcome with sacubitril-valsartan over an ACE/ARB (13.3% vs 13.2%, p = 0.95), or among the components of mortality (5.0% vs 5.8%, p = 0.58) or heart transplantation (8.7% vs 7.5%, p = 0.50). Patients who were receiving full goal-directed medical therapy (14.4% vs 16.0%, p = 0.55) also showed no difference in the composite outcome. We observed a significantly increased incidence of hypotension (10% vs 5.2%, p = 0.006) and a trend toward reduced number of hospitalizations per year (mean (SD) 1.3 (4.4) vs 2.0 (9.1), p = 0.09).
CONCLUSIONS
CONCLUSIONS
Sacubitril-valsartan is not associated with a decrease in the composite of all-cause mortality or heart transplantation within 1 year. Future studies should evaluate the possible reduction in hospitalizations and optimal dosing to minimize hypotension.
Identifiants
pubmed: 38705701
pii: S1053-2498(24)00032-9
doi: 10.1016/j.healun.2024.01.012
pii:
doi:
Substances chimiques
Aminobutyrates
0
Biphenyl Compounds
0
Drug Combinations
0
sacubitril and valsartan sodium hydrate drug combination
WB8FT61183
Valsartan
80M03YXJ7I
Angiotensin Receptor Antagonists
0
Tetrazoles
0
Angiotensin-Converting Enzyme Inhibitors
0
Types de publication
Journal Article
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
826-831Informations de copyright
Copyright © 2024 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Disclosure statement Z.E.H., L.P., S.J., and W.R. report no conflicts of interest for this work. This work was not financially supported. This work has been accepted for abstract presentation at the American Academy of Pediatrics and the World Congress of Pediatric Cardiology and Cardiac Surgery