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An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray
The global exposure of Sativex(®) (Δ(9)-tetrahydrocannabinol [THC]:cannabidiol [CBD], nabiximols) is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS). An observational registry to collect safety da...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Dove Medical Press
2016
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113923/ https://www.ncbi.nlm.nih.gov/pubmed/27956834 http://dx.doi.org/10.2147/TCRM.S115014 |
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author | Etges, Tilden Karolia, Kari Grint, Thomas Taylor, Adam Lauder, Heather Daka, Brian Wright, Stephen |
author_facet | Etges, Tilden Karolia, Kari Grint, Thomas Taylor, Adam Lauder, Heather Daka, Brian Wright, Stephen |
author_sort | Etges, Tilden |
collection | PubMed |
description | The global exposure of Sativex(®) (Δ(9)-tetrahydrocannabinol [THC]:cannabidiol [CBD], nabiximols) is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS). An observational registry to collect safety data from patients receiving THC:CBD was set up following its approval in the UK, Germany, and Switzerland, with the aim of determining its long-term safety in clinical practice. Twice a year, the Registry was opened to prescribing physicians to voluntarily report data on patients’ use of THC:CBD, clinically significant adverse events (AEs), and special interest events. The Registry contains data from 941 patients with 2,213.98 patient-years of exposure. Within this cohort, 60% were reported as continuing treatment, while 83% were reported as benefiting from the treatment. Thirty-two percent of patients stopped treatment, with approximately one third citing lack of effectiveness and one quarter citing AEs. Psychiatric AEs of clinical significance were reported in 6% of the patients, 6% reported falls requiring medical attention, and suicidality was reported in 2%. Driving ability was reported to have worsened in 2% of patients, but improved in 7%. AEs were more common during the first month of treatment. The most common treatment-related AEs included dizziness (2.3%) and fatigue (1.7%). There were no signals to indicate abuse, diversion, or dependence. The long-term risk profile from the Registry is consistent with the known (labeled) safety profile of THC:CBD, and therefore supports it being a well-tolerated and beneficial medication for the treatment of MS spasticity. No evidence of new long-term safety concerns has emerged. |
format | Online Article Text |
id | pubmed-5113923 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-51139232016-12-12 An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray Etges, Tilden Karolia, Kari Grint, Thomas Taylor, Adam Lauder, Heather Daka, Brian Wright, Stephen Ther Clin Risk Manag Original Research The global exposure of Sativex(®) (Δ(9)-tetrahydrocannabinol [THC]:cannabidiol [CBD], nabiximols) is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS). An observational registry to collect safety data from patients receiving THC:CBD was set up following its approval in the UK, Germany, and Switzerland, with the aim of determining its long-term safety in clinical practice. Twice a year, the Registry was opened to prescribing physicians to voluntarily report data on patients’ use of THC:CBD, clinically significant adverse events (AEs), and special interest events. The Registry contains data from 941 patients with 2,213.98 patient-years of exposure. Within this cohort, 60% were reported as continuing treatment, while 83% were reported as benefiting from the treatment. Thirty-two percent of patients stopped treatment, with approximately one third citing lack of effectiveness and one quarter citing AEs. Psychiatric AEs of clinical significance were reported in 6% of the patients, 6% reported falls requiring medical attention, and suicidality was reported in 2%. Driving ability was reported to have worsened in 2% of patients, but improved in 7%. AEs were more common during the first month of treatment. The most common treatment-related AEs included dizziness (2.3%) and fatigue (1.7%). There were no signals to indicate abuse, diversion, or dependence. The long-term risk profile from the Registry is consistent with the known (labeled) safety profile of THC:CBD, and therefore supports it being a well-tolerated and beneficial medication for the treatment of MS spasticity. No evidence of new long-term safety concerns has emerged. Dove Medical Press 2016-11-11 /pmc/articles/PMC5113923/ /pubmed/27956834 http://dx.doi.org/10.2147/TCRM.S115014 Text en © 2016 Etges et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Etges, Tilden Karolia, Kari Grint, Thomas Taylor, Adam Lauder, Heather Daka, Brian Wright, Stephen An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray |
title | An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray |
title_full | An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray |
title_fullStr | An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray |
title_full_unstemmed | An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray |
title_short | An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex(®) (THC:CBD, nabiximols) oromucosal spray |
title_sort | observational postmarketing safety registry of patients in the uk, germany, and switzerland who have been prescribed sativex(®) (thc:cbd, nabiximols) oromucosal spray |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113923/ https://www.ncbi.nlm.nih.gov/pubmed/27956834 http://dx.doi.org/10.2147/TCRM.S115014 |
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