Long-term safety and treatment effects of cannabidiol in children and adults with treatment-resistant epilepsies: Expanded access program results
| Autor: | Jerzy P, Szaflarski, Elizabeth Martina, Bebin, Anne M, Comi, Anup D, Patel, Charuta, Joshi, Daniel, Checketts, Jules C, Beal, Linda C, Laux, Lisa M, De Boer, Matthew H, Wong, Merrick, Lopez, Orrin, Devinsky, Paul D, Lyons, Pilar Pichon, Zentil, Robert, Wechsler, Arie, Weinstock |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Drug Resistant Epilepsy Pediatrics medicine.medical_specialty Adolescent efficacy education digestive system Young Adult cannabidiol 03 medical and health sciences 0302 clinical medicine treatment‐resistant epilepsy Interim medicine Humans Longitudinal Studies 030212 general & internal medicine tolerability Child Treatment resistant seizures Dose-Response Relationship Drug business.industry Infant Newborn Infant Middle Aged United States digestive system diseases Treatment Outcome surgical procedures operative expanded access program Neurology Child Preschool Expanded access Full‐length Original Research Anticonvulsants Female Neurology (clinical) Long term safety business Cannabidiol 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Epilepsia |
| ISSN: | 0013-9580 |
| Popis: | Summary Objective Since 2014, cannabidiol (CBD) has been administered to patients with treatment‐resistant epilepsies (TREs) in an ongoing expanded‐access program (EAP). We report interim results on the safety and efficacy of CBD in EAP patients treated through December 2016. Methods Twenty‐five US‐based EAP sites enrolling patients with TRE taking stable doses of antiepileptic drugs (AEDs) at baseline were included. During the 4‐week baseline period, parents/caregivers kept diaries of all countable seizure types. Patients received oral CBD starting at 2‐10 mg/kg/d, titrated to a maximum dose of 25‐50 mg/kg/d. Patient visits were every 2‐4 weeks through 16 weeks and every 2‐12 weeks thereafter. Efficacy endpoints included the percentage change from baseline in median monthly convulsive and total seizure frequency, and percentage of patients with ≥50%, ≥75%, and 100% reductions in seizures vs baseline. Data were analyzed descriptively for the efficacy analysis set and using the last‐observation‐carried‐forward method to account for missing data. Adverse events (AEs) were documented at each visit. Results Of 607 patients in the safety dataset, 146 (24%) withdrew; the most common reasons were lack of efficacy (89 [15%]) and AEs (32 [5%]). Mean age was 13 years (range, 0.4‐62). Median number of concomitant AEDs was 3 (range, 0‐10). Median CBD dose was 25 mg/kg/d; median treatment duration was 48 weeks. Add‐on CBD reduced median monthly convulsive seizures by 51% and total seizures by 48% at 12 weeks; reductions were similar through 96 weeks. Proportion of patients with ≥50%, ≥75%, and 100% reductions in convulsive seizures were 52%, 31%, and 11%, respectively, at 12 weeks, with similar rates through 96 weeks. CBD was generally well tolerated; most common AEs were diarrhea (29%) and somnolence (22%). Significance Results from this ongoing EAP support previous observational and clinical trial data showing that add‐on CBD may be an efficacious long‐term treatment option for TRE. |
| Databáze: | OpenAIRE |
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