Title

Variability in Serum Concentrations and Clinical Response in Artisanal Versus Pharmaceutical Cannabidiol Treatment of Pediatric Pharmacoresistant Epilepsy

Document Type

Journal Article

Publication Date

1-1-2022

Journal

The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG

Volume

27

Issue

6

DOI

10.5863/1551-6776-27.6.558

Keywords

Dravet syndrome; Epidiolex; Lennox-Gastaut syndrome; artisanal cannabidiol; cannabidiol; pediatric epilepsy

Abstract

OBJECTIVE: We hypothesized that serum cannabidiol (CBD) concentrations would be higher in patients taking pharmaceutical- versus artisanal-CBD oil, and higher serum CBD concentrations would correlate with increased side effects and decreased seizure frequency. METHODS: This was a retrospective chart review. We included patients with pharmacoresistant epilepsy, treated with artisanal-CBD or pharmaceutical-CBD (Epidiolex), and with quantitative serum CBD concentrations. We tracked epilepsy diagnosis, artisanal-CBD dosage, pharmaceutical-CBD dose, serum CBD concentration, clobazam concentration, N-desmethylclobazam concentration, seizure history (frequency of motor seizures), response to medication (percentage reduction in motor seizures), and side effects. RESULTS: Forty-two patients met inclusion criteria. Mean serum CBD concentration was 51.1 ng/mL (artisanal group) and 124 ng/mL (pharmaceutical group) (p = 0.022). Patients receiving artisanal-CBD had no change in median overall seizures (IQR, -50% to 50%); the pharmaceutical-CBD group had median 50% reduction (IQR, -90% to no change) (p = 0.199). CONCLUSIONS: Pharmaceutical-CBD achieves higher serum CBD concentrations than artisanal-CBD in pediatric patients with refractory epilepsy. These higher CBD concentrations are associated with increased reported adverse effects, but no detectable difference in seizure frequency.

Department

Pediatrics

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