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THC:CBD in Daily Practice: Available Data from UK, Germany and Spain.
Eur Neurol. 2016; 75 Suppl 1:1-3.EN

Abstract

BACKGROUND

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.

METHODS

A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported.

RESULTS

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.

CONCLUSIONS

The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice.

Authors+Show Affiliations

Institute of Clinical Neuroscience, Neurology Department, Hospital Regional Universitario Carlos Haya, FIMABIS, Malaga, Spain.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26901342

Citation

Fernández, Óscar. "THC:CBD in Daily Practice: Available Data From UK, Germany and Spain." European Neurology, vol. 75 Suppl 1, 2016, pp. 1-3.
Fernández Ó. THC:CBD in Daily Practice: Available Data from UK, Germany and Spain. Eur Neurol. 2016;75 Suppl 1:1-3.
Fernández, Ó. (2016). THC:CBD in Daily Practice: Available Data from UK, Germany and Spain. European Neurology, 75 Suppl 1, 1-3. https://doi.org/10.1159/000444234
Fernández Ó. THC:CBD in Daily Practice: Available Data From UK, Germany and Spain. Eur Neurol. 2016;75 Suppl 1:1-3. PubMed PMID: 26901342.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - THC:CBD in Daily Practice: Available Data from UK, Germany and Spain. A1 - Fernández,Óscar, Y1 - 2016/02/23/ PY - 2016/2/23/entrez PY - 2016/2/24/pubmed PY - 2016/10/7/medline SP - 1 EP - 3 JF - European neurology JO - Eur. Neurol. VL - 75 Suppl 1 N2 - BACKGROUND: 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. METHODS: A retrospective registry study and a prospective safety study of THC:CBD oromucosal spray are reported. RESULTS: 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. CONCLUSIONS: The homogeneity between these observational studies supports the interest in THC:CBD oromucosal spray for management of MS spasticity in daily practice. SN - 1421-9913 UR - https://www.unboundmedicine.com/medline/citation/26901342/THC:CBD_in_Daily_Practice:_Available_Data_from_UK_Germany_and_Spain_ L2 - https://www.karger.com?DOI=10.1159/000444234 DB - PRIME DP - Unbound Medicine ER -