[Safety and efficacy of oral trans-mucosal fentanyl citrate in the long-term treatment of breakthrough pain in oncology patients: the ECODIR study].
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.
Valentín Maganto
Vicente
V
Servicio de Oncología Médica, Hospital Universitario 12 de Octubre, Avenida Cordoba km 4500, 28045 Madrid, Spain. VVMM@eresmas.com
Camps Herrero
Carlos
C
Carulla Torrent
Joan
J
Cassinello Espinosa
Javier
J
Dorta Delgado
Javier
J
Jara Sánchez
Carlos
C
Moreno Nogueira
José Andrés
JA
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
D000701:Analgesics, Opioid; D005283:Fentanyl