[Safety and efficacy of oral trans-mucosal fentanyl citrate in the long-term treatment of breakthrough pain in oncology patients: the ECODIR study]. / Tolerabilidad y efectividad del citrato de fentanilo oral transmucosa en el tratamiento a largo plazo del dolor irruptivo en pacientes oncológicos: estudio ECODIR.

INTRODUCTION: 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.

Tolerabilidad y efectividad del citrato de fentanilo oral transmucosa en el tratamiento a largo plazo del dolor irruptivo en pacientes oncológicos: estudio ECODIR / Safety and efficacy of oral trans-mucosal fentanyl citrate in the long-term treatment of breakthrough pain in oncology patients: the ECODIR study

Introducción. El citrato de fentanilo oral transmucosa (CFOT) es el único fármaco desarrollado específicamente para el tratamiento del dolor irruptivo (DI). Este estudio evalúa la seguridad y efectividad a largo plazo del CFOT en condiciones asistenciales habituales. Pacientes y métodos. Estudio observacional de 6 meses de duración, realizado en pacientes oncológicos con crisis de DI. Se evaluó la seguridad del fármaco recogiendo las reacciones adversas y su efectividad, midiendo intensidad y tiempo de respuesta del episodio de DI por el paciente. Resultados. Participaron 174 pacientes. Las reacciones adversas recogidas fueron leves o moderadas. El CFOT fue significativamente más rápido (tiempo hasta alivio del dolor: 12,7 ± 11,4 minutos frente a 32,7 ± 18,4 minutos; p < 0,001) y potente (reducción intensidad del DI: 3,4 ± 1,5; frente a 4,3 ± 1,5; p < 0,001) que los fármacos utilizados previamente. Conclusiones. Este estudio observacional confirma el buen perfil de seguridad y efectividad del CFOT a largo plazo en el tratamiento del DI

Introduction. 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