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Tytuł pozycji:

Long-term safety and efficacy of highly purified cannabidiol for treatment refractory epilepsy.

Tytuł:
Long-term safety and efficacy of highly purified cannabidiol for treatment refractory epilepsy.
Autorzy:
Gaston TE; Department of Neurology and the UAB Epilepsy Center, University of Alabama at Birmingham, Birmingham, AL, USA; Veteran's Administration Medical Center, Birmingham, AL, USA. Electronic address: .
Ampah SB; Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
Martina Bebin E; Department of Neurology and the UAB Epilepsy Center, University of Alabama at Birmingham, Birmingham, AL, USA.
Grayson LP; Department of Neurology and the UAB Epilepsy Center, University of Alabama at Birmingham, Birmingham, AL, USA; Veteran's Administration Medical Center, Birmingham, AL, USA.
Cutter GR; Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.
Hernando K; Department of Neurology and the UAB Epilepsy Center, University of Alabama at Birmingham, Birmingham, AL, USA.
Szaflarski JP; Department of Neurology and the UAB Epilepsy Center, University of Alabama at Birmingham, Birmingham, AL, USA.
Corporate Authors:
UAB CBD Program
Źródło:
Epilepsy & behavior : E&B [Epilepsy Behav] 2021 Apr; Vol. 117, pp. 107862. Date of Electronic Publication: 2021 Mar 02.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Original Publication: San Diego, CA : Academic Press, c2000-
MeSH Terms:
Cannabidiol*/therapeutic use
Drug Resistant Epilepsy*/drug therapy
Epilepsy*/drug therapy
Adult ; Anticonvulsants/adverse effects ; Child ; Humans ; Seizures/drug therapy ; Treatment Outcome
Contributed Indexing:
Keywords: Adverse effects profile; Cannabidiol; Longitudinal data; Seizure frequency; Treatment resistant epilepsy
Substance Nomenclature:
0 (Anticonvulsants)
19GBJ60SN5 (Cannabidiol)
Entry Date(s):
Date Created: 20210305 Date Completed: 20210420 Latest Revision: 20210420
Update Code:
20240104
DOI:
10.1016/j.yebeh.2021.107862
PMID:
33667843
Czasopismo naukowe
Objective: To evaluate the safety, efficacy, and tolerability of highly purified cannabidiol (CBD) for the treatment of seizures in children and adults with treatment-resistant epilepsy (TRE) in an open-label, expanded access program (EAP).
Methods: One hundred sixty-nine participants (89 children and 80 adults) with TRE received plant-derived highly purified CBD (Epidiolex® in the U.S.; 100 mg/mL oral solution) with a starting dose of 5 mg/kg/day divided twice per day and titrated to a maximum dose of 50 mg/kg/day over the study period to seizure control and tolerability and followed for up to 2 years. Seizure frequency (calendars) and severity (Chalfont Seizure Severity Score; CSSS) were collected at every study visit. Adverse Events were reported at/between study visits as required, and participants also completed Adverse Events Profile (AEP) which generates a numerical representation of AEs. Response to CBD was defined as ≥50% reduction in seizure frequency. Given non-normal distribution of seizure frequency, a log transformation was applied after which the generalized least squares regression model for longitudinal data was used.
Results: Evidence from the adjusted model revealed a significant mean reduction in seizure frequency compared to baseline in children and adults at all time points (1 month and 1 and 2 years). Percentage of children achieving ≥50% seizure frequency reduction was 44% at month 1, and 41% at year 1, and 61% reduction at year 2, while adult responder rates were 34% at month 1, 53% at year 1, and 71% at year 2 (all P < 0.0001). CSSS showed a sustained reduction from baseline to all 3 time points. Children displayed 52% seizure reduction at month 1, a 51% reduction at year 1, and 75% reduction at year 2. Seizure reductions in adults were 60%, 81%, and 85%, respectively (all P < 0.0001). While there were no significant differences between seizure frequency reduction between children and adults at all time points, there was a significant difference in seizure severity reduction at year 1, with adults reporting greater improvement in seizure severity (P < 0.001). The most commonly reported adverse events in the study period were diarrhea, sedation, and decreased appetite. AEP revealed significant improvement from baseline at multiple time points in adults and children, and the mean AEP scores were always lower compared to baseline over the duration of the study.
Significance: Our study provides further evidence of sustained seizure frequency and severity reduction over two years of treatment with highly purified CBD in TRE. In addition, CBD was generally well tolerated with minority of participants experiencing adverse events resulting in stopping CBD.
(Published by Elsevier Inc.)

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