Effectiveness of cannabidiol in a prospective cohort of children with drug-resistant epileptic encephalopathy in Argentina

Caraballo, Roberto; Demirdjian, Graciela; Reyes, Gabriela; Huaman, Marina; Gutiérrez, Robinson

doi:10.1016/j.seizure.2020.06.005

Cited by 10 publications

(12 citation statements)

References 25 publications

(51 reference statements)

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“…CBD treatment was well tolerated, effective, and safe in all patients, with only mild or moderate adverse events, as reported elsewhere 3 . Nonetheless, due to the reduced number of patients enrolled, we were unable to establish a relation between CBD exposure and response.…”

Section: Discussionmentioning

confidence: 49%

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Pharmacokinetics of cannabidiol in children with refractory epileptic encephalopathy

et al. 2020

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Growing interest in the clinical use of cannabidiol (CBD) as adjuvant therapy for pediatric refractory epileptic encephalopathy emphasizes the need for drug treatment optimization. The aim of this study was to characterize the pharmacokinetics of CBD in pediatric patients with refractory epileptic encephalopathy receiving an oil‐based oral solution. To evaluate CBD concentrations, six serial blood samples per patient were collected after the morning dose of CBD, at least 21 days after the beginning of treatment. Twelve patients who received a median (range) dose of 12.2 (5.3‐19.4) mg/kg/d (twice daily) were included in the analysis. Median (range) CBD time to maximum plasma concentration, maximum plasma concentration, and area under the concentration versus time curve up to 6 hours after dosing were 3.2 hours (1.9‐6.2), 49.6 ng/mL (14.4‐302.0), and 226.3 ng ⋅ h/mL (70.5‐861.3), respectively. CBD systemic exposure parameters were in the lower range of previous reports in pediatric patients receiving doses in a similar range. Most of our patients (83%) showed little CBD plasma level fluctuation during a dosing interval, comparable to that encountered after oral administration of an extended release drug delivery system. CDB administration was generally safe and well tolerated, and a novel levothyroxine‐CBD interaction was recorded. Similar to other studies, large interindividual variability in CBD exposure was observed, encouraging the use of CBD therapeutic drug monitoring.

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Section: Discussionmentioning

confidence: 49%

“…Patients between 2 and 16 years old with REE treated at the Department of Neurology were included in the pharmacokinetic study after parents or guardians provided informed consent 3 …”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of cannabidiol in children with refractory epileptic encephalopathy

et al. 2020

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“…There is limited information about the effects of cannabidiol in patients with DEE. A 75% reduction in seizure frequency has been reported in a single patient, with an EEG showing isolated focal abnormalities that remained unaffected by the treatment [38].…”

Section: Treatmentmentioning

confidence: 87%

“…Other mutations. Caraballo et al described a patient with EIFMS secondary to an SCN2A mutation who became seizure-free after the initiation of cannabidiol [38]. Similarly, Saade and Joshi reported a case with developmental improvement and a sustained decrease in seizures after cannabidiol treatment was initiated [39].…”

Section: Treatmentmentioning

confidence: 99%

Uncommon epileptic syndromes in children: a review

Jara

Vásquez-Hernández

Ramírez-Rojo

et al. 2021

Seizure

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“…Alguns desses eventos, como a sonolência, por exemplo, foram associados a uma possível interação do CBD com o clobazam. Como forma de diminuir os efeitos negativos, a dose de clobazam foi reduzida sem comprometimento da eficácia do tratamento(CARABALLO et al, 2020).Os estudos para comprovar os efeitos dos canabinoides são crescentes,Mitelpunkt et al (2019) relatou que esses estudos são cada dia mais promissores, tendo em vista que os dados já obtidos possuem uma representativa taxa de redução nestas crises.…”

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