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Real-World Evidence of Factors Affecting Cannabidiol Exposure in Children with Drug-Resistant Developmental and Epileptic Encephalopathies.
Brstilo, Lucas; Reyes Valenzuela, Gabriela; Caraballo, Roberto; Pérez Montilla, Carlos; García Bournissen, Facundo; Cáceres Guido, Paulo; Schaiquevich, Paula.
Afiliação
  • Brstilo L; Unit of Innovative Treatments, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.
  • Reyes Valenzuela G; National Scientific and Technological Research Council (CONICET), Buenos Aires C1033AAJ, Argentina.
  • Caraballo R; Neurology Service, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.
  • Pérez Montilla C; Neurology Service, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.
  • García Bournissen F; Multidisciplinary Institute for Research on Pediatric Diseases, Parasitology and Chagas Service, Buenos Aires Children's Hospital Ricardo Gutierrez, Buenos Aires C1425EFD, Argentina.
  • Cáceres Guido P; Division of Pediatric Clinical Pharmacology, Department of Pediatrics, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON N6A 3K7, Canada.
  • Schaiquevich P; Pharmacokinetics and Research in Clinical Pharmacology Unit, Hospital de Pediatría Prof. Dr. JP Garrahan, Buenos Aires C1245AAM, Argentina.
Pharmaceutics ; 15(8)2023 Aug 10.
Article em En | MEDLINE | ID: mdl-37631333
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 (ß = 0.74 ± 0.1649, p < 0.001), 56.8% with food (ß = 0.45 ± 0.1550, p < 0.01), and 116.0% after intake of a ketogenic diet (ß = 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: Pharmaceutics Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Argentina País de publicação: Suíça
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Prognostic_studies Idioma: En Revista: Pharmaceutics Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Argentina País de publicação: Suíça