title: [Safety and efficacy of oral trans-mucosal fentanyl citrate in the long-term treatment of breakthrough pain in oncology patients: the ECODIR study].
abstract: BACKGROUND
  Oral trans-mucosal fentanyl citrate (OTFC) is the one drug specifically developed for the management of breakthrough pain. This study assesses the long-term safety and efficacy of OTFC standard clinical conditions. Patients and methods. Six-month observational study performed on cancer patients with episodes of breakthrough pain. Safety was assessed by recording the advent of adverse events and efficacy by the evaluating the intensity of breakthrough pain.
  
  
  RESULTS
  174 cancer patients were recruited into the study. All adverse reactions reported were mild or moderate. OTFC was significantly faster (time to the commencement of pain relief: 12.7 +/- 11.4 vs 32.7 +/- 18.4 minutes; p < 0.001) and potent (post-treatment pain intensity: 3.4 +/- 1.5 vs 4.3 +/- 1.5; p < 0.001) than the previously-used drugs.
  
  
  CONCLUSIONS
  This observational study confirms the good safety profile of OTFC as well as its effectiveness over long-term period treatment of breakthrough pain.
authors.affiliation: Servicio de Oncología Médica, Hospital Universitario 12 de Octubre, Avenida Cordoba km 4500, 28045 Madrid, Spain. VVMM@eresmas.com
authors.forename: Vicente
authors.initials: V
authors.lastname: Valentín Maganto
authors.forename: Carlos
authors.initials: C
authors.lastname: Camps Herrero
authors.forename: Joan
authors.initials: J
authors.lastname: Carulla Torrent
authors.forename: Javier
authors.initials: J
authors.lastname: Cassinello Espinosa
authors.forename: Javier
authors.initials: J
authors.lastname: Dorta Delgado
authors.forename: Carlos
authors.initials: C
authors.lastname: Jara Sánchez
authors.forename: José Andrés
authors.initials: JA
authors.lastname: Moreno Nogueira
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa; D010147:Pain Measurement / Q000379:methods; D010148:Intractable Pain / Q000188:drug therapy*; D012449:Safety; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D005283:Fentanyl