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An Open Retrospective Study of a Standardized Cannabidiol Based-Oil in Treatment-Resistant Epilepsy

Title: An Open Retrospective Study of a Standardized Cannabidiol Based-Oil in Treatment-Resistant Epilepsy
Authors: Marchese, Francesca; Vari, Maria Stella; Balagura, Ganna; Riva, Antonella; Salpietro, Vincenzo; Verrotti, Alberto; Citraro, Rita; Lattanzi, Simona; Minetti, Carlo; Russo, Emilio; Striano, Pasquale
Contributors: Marchese, Francesca; Vari, Maria Stella; Balagura, Ganna; Riva, Antonella; Salpietro, Vincenzo; Verrotti, Alberto; Citraro, Rita; Lattanzi, Simona; Minetti, Carlo; Russo, Emilio; Striano, Pasquale
Publication Year: 2022
Collection: Università Politecnica delle Marche: IRIS
Subject Terms: cannabidiol; drug resistance; epilepsy; treatment
Description: Introduction: Cannabidiol (CBD) has antiseizure properties but no psychoactive effects. Randomized controlled trials of an oral, pharmaceutical formulation of highly purified CBD are promising; however, data regarding other formulations are sparse and anecdotal. We evaluated the effectiveness of add-on therapy with a standardized CBD-based oil in treatment-resistant epilepsy (TRE) patients. Materials and Methods: An open retrospective study was carried out on patients with refractory epilepsy of different etiology. We reviewed clinical data from medical charts and caregiver's information. Participants received add-on with 24% CBD-based oil, sublingually administered, at the starting dose of 5-10 mg/[kg·day] up to the maximum dose of 50 mg/[kg·day], based on clinical efficacy. Efficacy was evaluated based on patients being seizure free or experiencing at ≥50% improvement on seizure frequency. Tolerability and suspected adverse drug reaction data were also analyzed. Results: We included 37 patients (46% female) with a median age of 16.1 (range: 2-54) years. Twenty-two (60%) patients suffered from epileptic encephalopathy, 9 (24%) from focal epilepsy, and 6 (16%) from generalized epilepsy. Mean follow-up duration was 68 (range: 24-72) weeks. The average age at seizure onset was 3.8±2.1 years (range: 7 days-21 years). The median achieved CBD-based oil dose was 4.2±11.4 (range: 0.6-50) mg/[kg·day]. At 40-month follow-up, 7 (19%) patients were seizure free, 27 (73%) reported >50% improvement, 2 (5%) patients reported
Document Type: article in journal/newspaper
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/33998856; info:eu-repo/semantics/altIdentifier/wos/WOS:000821411500011; volume:7; issue:2; firstpage:199; lastpage:206; numberofpages:8; journal:CANNABIS AND CANNABINOID RESEARCH; https://hdl.handle.net/11566/292360
DOI: 10.1089/can.2019.0082
Availability: https://hdl.handle.net/11566/292360; https://doi.org/10.1089/can.2019.0082
Rights: info:eu-repo/semantics/openAccess
Accession Number: edsbas.B26E1AFB
Database: BASE