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Title: THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.
Authors: Fernández, Óscar
metadata.dc.subject.mesh: Accidental Falls
Drug Combinations
Marijuana Abuse
Medical Marijuana
Multiple Sclerosis
Muscle Spasticity
Oral Sprays
Plant Extracts
Prospective Studies
Retrospective Studies
Treatment Outcome
United Kingdom
Issue Date: 23-Feb-2016
Abstract: From the time Sativex (THC:CBD) oromucosal spray first became available in European Union countries in 2010 for the management of treatment-resistant multiple sclerosis (MS) spasticity, data from daily practice have been collected through various projects. A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported. The most recent analysis of a retrospective registry established in the United Kingdom (UK), Germany and Switzerland, which collected safety data on more than 900 patients, has indicated a positive risk-benefit profile for THC:CBD oromucosal spray during long-term use. Long-term continuation rates were 68% (mean follow-up time 1 year) and the mean dose was 5.4 sprays/day. No new safety concerns were identified, and adverse events of special interest for a cannabis-based medicine were limited. The UK registry has since been closed but remains open in Germany and Switzerland. A prospective safety study undertaken in Spain involved 207 patients from 13 specialized MS centres who had been prescribed THC:CBD oromucosal spray. The findings aligned closely with the UK/German/Swiss registry data in terms of 1-year continuation rates (64.7%), mean daily dose (6.6 sprays/day) and safety profile, including no evidence of addiction, abuse or misuse. The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice.
metadata.dc.identifier.doi: 10.1159/000444234
Appears in Collections:Producción 2020

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