Long‐term safety and efficacy of add‐on cannabidiol in patients with Lennox–Gastaut syndrome: Results of a long‐term open‐label extension trial
| العنوان: | Long‐term safety and efficacy of add‐on cannabidiol in patients with Lennox–Gastaut syndrome: Results of a long‐term open‐label extension trial |
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| المؤلفون: | Elizabeth A. Thiele, Anup D. Patel, Orrin Devinsky, Daniel Checketts, Arie Weinstock, Wendy G. Mitchell, Antonio Gil-Nagel, Richard F.M. Chin, Michael Scott Perry, Maria Mazurkiewicz-Bełdzińska, Eduardo Dunayevich, Boudewijn Gunning, Jonathan J. Halford |
| المصدر: | Epilepsia. 62:2228-2239 |
| بيانات النشر: | Wiley, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | medicine.medical_specialty, Epilepsies, Myoclonic, law.invention, Randomized controlled trial, Seizures, law, Internal medicine, Convulsion, medicine, Cannabidiol, Humans, media_common.cataloged_instance, European union, media_common, Valproic Acid, Lennox Gastaut Syndrome, Maintenance dose, business.industry, medicine.disease, Neurology, Tolerability, Concomitant, Anticonvulsants, Neurology (clinical), medicine.symptom, business, medicine.drug, Lennox–Gastaut syndrome |
| الوصف: | Objective Lennox-Gastaut syndrome (LGS) is an epileptic encephalopathy that is often treatment resistant. Efficacy and safety of add-on cannabidiol (CBD) to treat seizures associated with LGS was demonstrated in two randomized controlled trials (RCTs). Patients who completed the RCTs were invited to enroll in this long-term open-label extension (OLE) trial, GWPCARE5 (NCT02224573). We present the final analysis of safety and efficacy outcomes from GWPCARE5. Methods Patients received plant-derived highly purified CBD (Epidiolex in the United States; Epidyolex in the European Union; 100 mg/ml oral solution), titrated to a target maintenance dose of 20 mg/kg/day over 2 weeks. Based on response and tolerability, CBD could then be reduced or increased up to 30 mg/kg/day. Results Of 368 patients with LGS who completed the RCTs, 366 (99.5%) enrolled in this OLE. Median and mean treatment duration were 1090 and 826 days (range = 3-1421), respectively, with a mean modal dose of 24 mg/kg/day. Adverse events (AEs) occurred in 96% of patients, serious AEs in 42%, and AE-related discontinuations in 12%. Common AEs were convulsion (39%), diarrhea (38%), pyrexia (34%), and somnolence (29%). Fifty-five (15%) patients experienced liver transaminase elevations more than three times the upper limit of normal; 40 (73%) were taking concomitant valproic acid. Median percent reductions from baseline ranged 48%-71% for drop seizures and 48%-68% for total seizures through 156 weeks. Across all 12-week visit windows, 87% or more of patients/caregivers reported improvement in the patient's overall condition on the Subject/Caregiver Global Impression of Change scale. Significance Long-term add-on CBD treatment had a similar safety profile as in the original RCTs. Sustained reductions in drop and total seizure frequency were observed for up to 156 weeks, demonstrating long-term benefits of CBD treatment for patients with LGS. |
| تدمد: | 1528-1167 0013-9580 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a08afbdfca63f2a79fe09d4cbd6a6964 https://doi.org/10.1111/epi.17000 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....a08afbdfca63f2a79fe09d4cbd6a6964 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15281167 00139580 |
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