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Cannabidiol effective in children with Dravet syndrome

AAN 2019
Cannabidiol (CBD) in a dosage of 10 or 20 mg/kg/day significantly reduced convulsive seizure frequency in children and adolescents with Dravet syndrome. This was concluded from GWPCARE, a dose-ranging, multicentre, randomised, double-blind, placebo-controlled trial [1]. CBD20 gave rise to more adverse events and discontinuations.

Dravet syndrome is an infantile-onset developmental and epileptic encephalopathy associated with drug-resistant seizures. In GWPCARE, a highly purified form of CBD was applied. The 199 children and adolescents with Dravet syndrome and drug-resistant seizures who participated, had a mean age of 9 years. They were randomised 1:1:1 to placebo or CBD in doses of 10 or 20 mg/kg/day (CBD10 or CBD20) as add-on anticonvulsant therapy.

Convulsive seizures during 14 weeks of treatment were reduced 27% in the placebo group, 49% in the CBD10 group (P=0.0095), and 46% in the CBD20 group (P=0.0299). There were also significantly more patients with a ≥50% reduction in convulsive seizures: 26% vs 44% (P=0.0332) and 49% (P=0.0069), respectively, as well as a higher reduction in total seizures: 30% vs 56% (P=0.0003) and 47% (P=0.0255). The incidence of adverse events was similar across all groups, around 89%. However, serious adverse events were reported in 15%, 20%, and 25% of patients, respectively. There were only discontinuations due to adverse events in the CBD20 group (7%). Elevated transaminases exceeding 3 times the upper limit of normal occurred in 5% of CBD10 and 19% of CBD20 patients; all elevations resolved. The authors concluded that any dose increase above 10 mg/kg/day should be guided by individual efficacy and safety.

1. Miller I, et al. AAN 2019, emerging science 006.

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