Adverse events associated with benznidazole treatment for Chagas disease in children and adults

Autores
Cruz, Cintia Valeria; Rabinovich, Andrés; Moscatelli, Guillermo; Moroni, Samanta; González, Nicolás Leonel; Garcia Bournissen, Facundo; Ballering, Griselda Edith; Freilij, Hector León; Altcheh, Jaime Marcelo
Año de publicación
2024
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Aims: Chagas disease (ChD) affects approximately 7 million people in Latin America,with benznidazole being the most commonly used treatment.Methods: Data from a retrospective cohort study in Argentina, covering January1980 to July 2019, was reanalysed to identify and characterize benznidazole-relatedadverse drug reactions (ADRs).Results: The study included 518 patients: 449 children and 69 adults (median age inchildren: 4 years; adults: 25 years; age ranges: 1 month–17.75 years and 18–59 years, respectively). The median benznidazole doses received were 6.6 mg/kg/day for at least 60 days in children and 5.6 mg/kg/day for a median of 31 days inadults. Overall, 29.34% (152/518) of patients developed benznidazole-related ADRs,with an incidence of 25.83% (116/449) in children and 52.17% (36/69) in adults(odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.19–0.54, P < .001). Theincidence rate was 177 cases per 1000 person-years (95% CI = 145–214) in childrenand 537 per 1000 person-years (95% CI = 360–771) in adults. There were 240 ADRsidentified, primarily mild to moderate. Severe ADRs occurred in 1.11% (5/449) ofchildren and 1.45% (1/69) of adults. The skin was the most affected system. A totalof 10.23% (53/518) of patients discontinued treatment. More adults than childrendiscontinued treatment (OR = 3.36, 95% CI = 1.7–6.4, P < .001).Conclusions: Although 29.34% of patients experienced ADRs, most were mild tomoderate, indicating a manageable safety profile for benznidazole. While optimizeddosing schedules and new drugs are needed, avoiding benznidazole solely due tosafety concerns is not justified.
Fil: Cruz, Cintia Valeria. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Rabinovich, Andrés. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Moscatelli, Guillermo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Moroni, Samanta. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: González, Nicolás Leonel. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: Garcia Bournissen, Facundo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Ballering, Griselda Edith. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: Freilij, Hector León. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: Altcheh, Jaime Marcelo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Materia
adults
adverse drug reactions
benznidazole
Chagas disease
Trypanosoma cruzi
children
congenital
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/266818
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/266818
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Adverse events associated with benznidazole treatment for Chagas disease in children and adultsCruz, Cintia ValeriaRabinovich, AndrésMoscatelli, GuillermoMoroni, SamantaGonzález, Nicolás LeonelGarcia Bournissen, FacundoBallering, Griselda EdithFreilij, Hector LeónAltcheh, Jaime Marceloadultsadverse drug reactionsbenznidazoleChagas diseaseTrypanosoma cruzichildrencongenitalhttps://purl.org/becyt/ford/1.6https://purl.org/becyt/ford/1Aims: Chagas disease (ChD) affects approximately 7 million people in Latin America,with benznidazole being the most commonly used treatment.Methods: Data from a retrospective cohort study in Argentina, covering January1980 to July 2019, was reanalysed to identify and characterize benznidazole-relatedadverse drug reactions (ADRs).Results: The study included 518 patients: 449 children and 69 adults (median age inchildren: 4 years; adults: 25 years; age ranges: 1 month–17.75 years and 18–59 years, respectively). The median benznidazole doses received were 6.6 mg/kg/day for at least 60 days in children and 5.6 mg/kg/day for a median of 31 days inadults. Overall, 29.34% (152/518) of patients developed benznidazole-related ADRs,with an incidence of 25.83% (116/449) in children and 52.17% (36/69) in adults(odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.19–0.54, P < .001). Theincidence rate was 177 cases per 1000 person-years (95% CI = 145–214) in childrenand 537 per 1000 person-years (95% CI = 360–771) in adults. There were 240 ADRsidentified, primarily mild to moderate. Severe ADRs occurred in 1.11% (5/449) ofchildren and 1.45% (1/69) of adults. The skin was the most affected system. A totalof 10.23% (53/518) of patients discontinued treatment. More adults than childrendiscontinued treatment (OR = 3.36, 95% CI = 1.7–6.4, P < .001).Conclusions: Although 29.34% of patients experienced ADRs, most were mild tomoderate, indicating a manageable safety profile for benznidazole. While optimizeddosing schedules and new drugs are needed, avoiding benznidazole solely due tosafety concerns is not justified.Fil: Cruz, Cintia Valeria. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; ArgentinaFil: Rabinovich, Andrés. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; ArgentinaFil: Moscatelli, Guillermo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; ArgentinaFil: Moroni, Samanta. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; ArgentinaFil: González, Nicolás Leonel. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; ArgentinaFil: Garcia Bournissen, Facundo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; ArgentinaFil: Ballering, Griselda Edith. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; ArgentinaFil: Freilij, Hector León. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; ArgentinaFil: Altcheh, Jaime Marcelo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; ArgentinaWiley Blackwell Publishing, Inc2024-08info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/266818Cruz, Cintia Valeria; Rabinovich, Andrés; Moscatelli, Guillermo; Moroni, Samanta; González, Nicolás Leonel; et al.; Adverse events associated with benznidazole treatment for Chagas disease in children and adults; Wiley Blackwell Publishing, Inc; British Journal Of Clinical Pharmacology; 90; 12; 8-2024; 3334-33470306-5251CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.16214info:eu-repo/semantics/altIdentifier/doi/10.1111/bcp.16214info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:14:17Zoai:ri.conicet.gov.ar:11336/266818instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:14:17.539CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Adverse events associated with benznidazole treatment for Chagas disease in children and adults
title Adverse events associated with benznidazole treatment for Chagas disease in children and adults
spellingShingle Adverse events associated with benznidazole treatment for Chagas disease in children and adults
Cruz, Cintia Valeria
adults
adverse drug reactions
benznidazole
Chagas disease
Trypanosoma cruzi
children
congenital
title_short Adverse events associated with benznidazole treatment for Chagas disease in children and adults
title_full Adverse events associated with benznidazole treatment for Chagas disease in children and adults
title_fullStr Adverse events associated with benznidazole treatment for Chagas disease in children and adults
title_full_unstemmed Adverse events associated with benznidazole treatment for Chagas disease in children and adults
title_sort Adverse events associated with benznidazole treatment for Chagas disease in children and adults
dc.creator.none.fl_str_mv Cruz, Cintia Valeria
Rabinovich, Andrés
Moscatelli, Guillermo
Moroni, Samanta
González, Nicolás Leonel
Garcia Bournissen, Facundo
Ballering, Griselda Edith
Freilij, Hector León
Altcheh, Jaime Marcelo
author Cruz, Cintia Valeria
author_facet Cruz, Cintia Valeria
Rabinovich, Andrés
Moscatelli, Guillermo
Moroni, Samanta
González, Nicolás Leonel
Garcia Bournissen, Facundo
Ballering, Griselda Edith
Freilij, Hector León
Altcheh, Jaime Marcelo
author_role author
author2 Rabinovich, Andrés
Moscatelli, Guillermo
Moroni, Samanta
González, Nicolás Leonel
Garcia Bournissen, Facundo
Ballering, Griselda Edith
Freilij, Hector León
Altcheh, Jaime Marcelo
author2_role author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv adults
adverse drug reactions
benznidazole
Chagas disease
Trypanosoma cruzi
children
congenital
topic adults
adverse drug reactions
benznidazole
Chagas disease
Trypanosoma cruzi
children
congenital
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.6
https://purl.org/becyt/ford/1
dc.description.none.fl_txt_mv Aims: Chagas disease (ChD) affects approximately 7 million people in Latin America,with benznidazole being the most commonly used treatment.Methods: Data from a retrospective cohort study in Argentina, covering January1980 to July 2019, was reanalysed to identify and characterize benznidazole-relatedadverse drug reactions (ADRs).Results: The study included 518 patients: 449 children and 69 adults (median age inchildren: 4 years; adults: 25 years; age ranges: 1 month–17.75 years and 18–59 years, respectively). The median benznidazole doses received were 6.6 mg/kg/day for at least 60 days in children and 5.6 mg/kg/day for a median of 31 days inadults. Overall, 29.34% (152/518) of patients developed benznidazole-related ADRs,with an incidence of 25.83% (116/449) in children and 52.17% (36/69) in adults(odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.19–0.54, P < .001). Theincidence rate was 177 cases per 1000 person-years (95% CI = 145–214) in childrenand 537 per 1000 person-years (95% CI = 360–771) in adults. There were 240 ADRsidentified, primarily mild to moderate. Severe ADRs occurred in 1.11% (5/449) ofchildren and 1.45% (1/69) of adults. The skin was the most affected system. A totalof 10.23% (53/518) of patients discontinued treatment. More adults than childrendiscontinued treatment (OR = 3.36, 95% CI = 1.7–6.4, P < .001).Conclusions: Although 29.34% of patients experienced ADRs, most were mild tomoderate, indicating a manageable safety profile for benznidazole. While optimizeddosing schedules and new drugs are needed, avoiding benznidazole solely due tosafety concerns is not justified.
Fil: Cruz, Cintia Valeria. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Rabinovich, Andrés. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Moscatelli, Guillermo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Moroni, Samanta. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: González, Nicolás Leonel. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: Garcia Bournissen, Facundo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
Fil: Ballering, Griselda Edith. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: Freilij, Hector León. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez". Servicio de Parasitología y Chagas; Argentina
Fil: Altcheh, Jaime Marcelo. Gobierno de la Ciudad de Buenos Aires. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay. Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas; Argentina
description Aims: Chagas disease (ChD) affects approximately 7 million people in Latin America,with benznidazole being the most commonly used treatment.Methods: Data from a retrospective cohort study in Argentina, covering January1980 to July 2019, was reanalysed to identify and characterize benznidazole-relatedadverse drug reactions (ADRs).Results: The study included 518 patients: 449 children and 69 adults (median age inchildren: 4 years; adults: 25 years; age ranges: 1 month–17.75 years and 18–59 years, respectively). The median benznidazole doses received were 6.6 mg/kg/day for at least 60 days in children and 5.6 mg/kg/day for a median of 31 days inadults. Overall, 29.34% (152/518) of patients developed benznidazole-related ADRs,with an incidence of 25.83% (116/449) in children and 52.17% (36/69) in adults(odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.19–0.54, P < .001). Theincidence rate was 177 cases per 1000 person-years (95% CI = 145–214) in childrenand 537 per 1000 person-years (95% CI = 360–771) in adults. There were 240 ADRsidentified, primarily mild to moderate. Severe ADRs occurred in 1.11% (5/449) ofchildren and 1.45% (1/69) of adults. The skin was the most affected system. A totalof 10.23% (53/518) of patients discontinued treatment. More adults than childrendiscontinued treatment (OR = 3.36, 95% CI = 1.7–6.4, P < .001).Conclusions: Although 29.34% of patients experienced ADRs, most were mild tomoderate, indicating a manageable safety profile for benznidazole. While optimizeddosing schedules and new drugs are needed, avoiding benznidazole solely due tosafety concerns is not justified.
publishDate 2024
dc.date.none.fl_str_mv 2024-08
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/266818
Cruz, Cintia Valeria; Rabinovich, Andrés; Moscatelli, Guillermo; Moroni, Samanta; González, Nicolás Leonel; et al.; Adverse events associated with benznidazole treatment for Chagas disease in children and adults; Wiley Blackwell Publishing, Inc; British Journal Of Clinical Pharmacology; 90; 12; 8-2024; 3334-3347
0306-5251
CONICET Digital
CONICET
url http://hdl.handle.net/11336/266818
identifier_str_mv Cruz, Cintia Valeria; Rabinovich, Andrés; Moscatelli, Guillermo; Moroni, Samanta; González, Nicolás Leonel; et al.; Adverse events associated with benznidazole treatment for Chagas disease in children and adults; Wiley Blackwell Publishing, Inc; British Journal Of Clinical Pharmacology; 90; 12; 8-2024; 3334-3347
0306-5251
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
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info:eu-repo/semantics/altIdentifier/doi/10.1111/bcp.16214
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Wiley Blackwell Publishing, Inc
publisher.none.fl_str_mv Wiley Blackwell Publishing, Inc
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.070432

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