Retrospective Chart Review Study of Use of Cannabidiol (CBD) Independent of Concomitant Clobazam Use in Patients with Lennox-Gastaut Syndrome or Dravet Syndrome - Université de Picardie Jules Verne Accéder directement au contenu
Article Dans Une Revue Seizure - European Journal of Epilepsy Année : 2023

Retrospective Chart Review Study of Use of Cannabidiol (CBD) Independent of Concomitant Clobazam Use in Patients with Lennox-Gastaut Syndrome or Dravet Syndrome

Résumé

Purpose This retrospective chart review study (GWEP20052) evaluated plant-derived highly purified cannabidiol (CBD; Epidyolex®; 100 mg/mL oral solution) use without clobazam as add-on therapy in patients aged ≥2 years with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) enrolled in a European Early Access Program. Methods Data were extracted from patient charts covering a period starting 3 months before CBD treatment and concluding after 12 months of CBD treatment, or sooner if a patient discontinued CBD or started clobazam. Results Of 114 enrolled patients, data were available for 107 (92 LGS, 15 DS) who received CBD without clobazam for ≥3 months. Mean age: 14.5 (LGS) and 10.5 (DS) years; female: 44% (LGS) and 67% (DS). Mean time-averaged CBD dose: 13.54 (LGS) and 11.56 (DS) mg/kg/day. Median change from baseline in seizure frequency per 28 days over 3-month intervals varied from −6.2% to −20.9% for LGS and 0% to −16.7% for DS. Achievement of ≥50% reduction in drop (LGS) or convulsive (DS) seizures at 3 and 12 months: LGS, 19% (n=69) and 30% (n=53); DS, 21% (n=14) and 13% (n=8). Retention on CBD without clobazam (enrolled set): 94%, 80%, 69%, and 63% at 3, 6, 9, and 12 months. Adverse event (AE) incidence was 31%, most commonly somnolence, seizure, diarrhoea, and decreased appetite. Two patients discontinued CBD owing to AEs, and four patients with LGS experienced elevated liver enzymes. Conclusion Results support favourable effectiveness and retention of CBD without concomitant clobazam for up to 12 months in clinical practice.

Dates et versions

hal-04105164 , version 1 (24-05-2023)

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Citer

Rima Nabbout, Alexis Arzimanoglou, Stéphane Auvin, Patrick Berquin, Archana Desurkar, et al.. Retrospective Chart Review Study of Use of Cannabidiol (CBD) Independent of Concomitant Clobazam Use in Patients with Lennox-Gastaut Syndrome or Dravet Syndrome. Seizure - European Journal of Epilepsy, 2023, ⟨10.1016/j.seizure.2023.05.003⟩. ⟨hal-04105164⟩
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