PMID- 27956834
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 1176-6336 (Print)
IS  - 1178-203X (Electronic)
IS  - 1176-6336 (Linking)
VI  - 12
DP  - 2016
TI  - An observational postmarketing safety registry of patients in the UK, Germany, 
      and Switzerland who have been prescribed Sativex((R)) (THC:CBD, nabiximols) 
      oromucosal spray.
PG  - 1667-1675
AB  - The global exposure of Sativex((R)) (Delta(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.
FAU - Etges, Tilden
AU  - Etges T
AD  - GW Pharmaceuticals, Cambridge, UK.
FAU - Karolia, Kari
AU  - Karolia K
AD  - GW Pharmaceuticals, Cambridge, UK.
FAU - Grint, Thomas
AU  - Grint T
AD  - GW Pharmaceuticals, Cambridge, UK.
FAU - Taylor, Adam
AU  - Taylor A
AD  - GW Pharmaceuticals, Cambridge, UK.
FAU - Lauder, Heather
AU  - Lauder H
AD  - GW Pharmaceuticals, Cambridge, UK.
FAU - Daka, Brian
AU  - Daka B
AD  - GW Pharmaceuticals, Cambridge, UK.
FAU - Wright, Stephen
AU  - Wright S
AD  - GW Pharmaceuticals, Cambridge, UK.
LA  - eng
PT  - Journal Article
DEP - 20161111
PL  - New Zealand
TA  - Ther Clin Risk Manag
JT  - Therapeutics and clinical risk management
JID - 101253281
PMC - PMC5113923
OTO - NOTNLM
OT  - cannabidiol
OT  - multiple sclerosis
OT  - non-interventional
OT  - risk management plan
OT  - spasticity
OT  - tetrahydrocannabinol
COIS- All authors are employees of GW Pharmaceuticals and hold shares in the company. 
      The authors report no other conflicts of interest in this work.
EDAT- 2016/12/14 06:00
MHDA- 2016/12/14 06:01
PMCR- 2016/11/11
CRDT- 2016/12/14 06:00
PHST- 2016/12/14 06:00 [entrez]
PHST- 2016/12/14 06:00 [pubmed]
PHST- 2016/12/14 06:01 [medline]
PHST- 2016/11/11 00:00 [pmc-release]
AID - tcrm-12-1667 [pii]
AID - 10.2147/TCRM.S115014 [doi]
PST - epublish
SO  - Ther Clin Risk Manag. 2016 Nov 11;12:1667-1675. doi: 10.2147/TCRM.S115014. 
      eCollection 2016.