Mostrar el registro sencillo del ítem
dc.contributor.author
Brstilo, Lucas Joel
dc.contributor.author
Reyes Valenzuela, Gabriela
dc.contributor.author
Caraballo, Roberto Horacio
dc.contributor.author
Pérez Montilla, Carlos Alberto
dc.contributor.author
García Bournissen, Facundo
dc.contributor.author
Caceres Guido, Paulo Arturo
dc.contributor.author
Schaiquevich, Paula Susana
dc.date.available
2023-12-28T13:27:51Z
dc.date.issued
2023-08
dc.identifier.citation
Brstilo, Lucas Joel; Reyes Valenzuela, Gabriela; Caraballo, Roberto Horacio; Pérez Montilla, Carlos Alberto; García Bournissen, Facundo; et al.; Real-World Evidence of Factors Affecting Cannabidiol Exposure in Children with Drug-Resistant Developmental and Epileptic Encephalopathies; Multidisciplinary Digital Publishing Institute; Pharmaceutics; 15; 8; 8-2023; 1-13
dc.identifier.uri
http://hdl.handle.net/11336/221769
dc.description.abstract
The identification of factors that affect cannabidiol (CBD) systemic exposure may aid in optimizing treatment efficacy and safety in clinical practice. In this study, we aimed to correlate CBD plasma concentrations at a steady state to demographic, clinical, and pharmacological characteristics as well as seizure frequency after the administration of a purified CBD oil solution in a real-world setting of children with drug-resistant developmental and epileptic encephalopathies (DEEs). Patients receiving oral CBD pharmaceutical products at maintenance were enrolled. Venous blood samples were drawn before the CBD morning dose, 12 h apart from the last evening dose (C0 or CBD trough concentration). A linear mixed-effect analysis was implemented to assess the correlation between C0 and clinical, laboratory, pharmacological, and lifestyle factors. Fifteen females and seven males with a median age of 12.8 years (ranging between 4.7 and 17.2) were included. The median CBD dose was 8.8 mg/kg/day (ranging between 2.6 and 22.5), and the CBD C0 median (range) was 48.2 ng/mL (3.5–366.3). The multivariate model showed a 109.6% increase in CBD C0 in patients with concomitant levothyroxine (β = 0.74 ± 0.1649, p < 0.001), 56.8% with food (β = 0.45 ± 0.1550, p < 0.01), and 116.0% after intake of a ketogenic diet (β = 0.77 ± 0.3141, p < 0.05). All patients included were responders without evidence of an association between C0 and response status. In children with DEEs, systemic concentrations of CBD may be significantly increased when co-administered with levothyroxine, food, or a ketogenic diet.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Multidisciplinary Digital Publishing Institute
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by/2.5/ar/
dc.subject
CANNABIDIOL
dc.subject
DRUG-RESISTANT DEVELOPMENTAL AND EPILEPTIC ENCEPHALOPATHIES
dc.subject
FOOD EFFECT
dc.subject
KETOGENIC DIET
dc.subject
LEVOTHYROXINE
dc.subject.classification
Farmacología y Farmacia
dc.subject.classification
Medicina Básica
dc.subject.classification
CIENCIAS MÉDICAS Y DE LA SALUD
dc.title
Real-World Evidence of Factors Affecting Cannabidiol Exposure in Children with Drug-Resistant Developmental and Epileptic Encephalopathies
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2023-12-26T13:41:45Z
dc.identifier.eissn
1999-4923
dc.journal.volume
15
dc.journal.number
8
dc.journal.pagination
1-13
dc.journal.pais
Suiza
dc.description.fil
Fil: Brstilo, Lucas Joel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
dc.description.fil
Fil: Reyes Valenzuela, Gabriela. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
dc.description.fil
Fil: Caraballo, Roberto Horacio. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
dc.description.fil
Fil: Pérez Montilla, Carlos Alberto. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Gobierno de la Ciudad de Buenos Aires. Hospital General de Niños "Ricardo Gutiérrez"; Argentina
dc.description.fil
Fil: García Bournissen, Facundo. University of Western Ontario; Canadá
dc.description.fil
Fil: Caceres Guido, Paulo Arturo. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
dc.description.fil
Fil: Schaiquevich, Paula Susana. Comisión Nacional de Investigación Científica y Tecnológica; Chile. Gobierno de la Ciudad de Buenos Aires. Hospital de Pediatría "Juan P. Garrahan"; Argentina
dc.journal.title
Pharmaceutics
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.mdpi.com/1999-4923/15/8/2120
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/https://doi.org/10.3390/pharmaceutics15082120
Archivos asociados