title: [Assessment of the effectiveness and safety of Sativex® in compassionate use].
abstract: BACKGROUND
  Sativex® is a drug approved for use in the treatment of spasticity in multiple sclerosis. We sought to study the tolerability and effectiveness of this drug product in pathologies beyond the scope of the indications of the product data sheet, by means of its compassionate use.
  
  
  OBJECTIVE
  To evaluate the effectiveness and safety of Sativex in pathologies that are not included on the product data sheet, using a compassionate use protocol.
  
  
  METHODS
  A six-month observational study was conducted to evaluate the effectiveness and safety of Sativex in neuropathic pain and in spasticity from causes other than multiple sclerosis.
  
  
  RESULTS
  A total of 10 patients were included: six females and four males. Side effects appeared in only two of them and the drug product was withdrawn in one case. After starting treatment with Sativex by means of a compassionate use protocol, the consumption of concomitant drugs was reduced by 34.2% (p=0.004), and administration of botulinum toxin was suspended in seven patients (70%). The improvement on the Ashworth spasticity scale was 65.6% (p=0.004) and the score on the analogical visual scale dropped by 49.2% (p=0.026).
  
  
  CONCLUSIONS
  Sativex may be an interesting therapeutic alternative in patients with spasticity and pain when the treatments that are usually available have been employed but patients' quality of life continues to be significantly compromised.
authors.affiliation: Hospital Povisa, 36211 Vigo, Espana.
authors.forename: Icíar
authors.initials: I
authors.lastname: Cimas-Hernando
authors.forename: Antonio
authors.initials: A
authors.lastname: Pato-Pato
authors.forename: José R
authors.initials: JR
authors.lastname: Lorenzo-González
authors.forename: Iria
authors.initials: I
authors.lastname: Rodríguez-Constenla
mesh_terms: D000328:Adult; D000368:Aged; D002185:Cannabidiol; D057176:Compassionate Use Trials; D013759:Dronabinol; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications; D009128:Muscle Spasticity / Q000188:drug therapy* / Q000209:etiology; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols