[Safety and efficacy of oral trans-mucosal fentanyl citrate in the long-term treatment of breakthrough pain in oncology patients: the ECODIR study].

Abstract

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.

• Authors: Vicente Valentín Maganto, Carlos Camps Herrero, Joan Carulla Torrent, Javier Cassinello Espinosa, Javier Dorta Delgado, Carlos Jara Sánchez, José Andrés Moreno Nogueira
• Journal: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico (Clin Transl Oncol) Vol. 7 Issue 5 Pg. 205-12 (Jun 2005) ISSN: 1699-048X [Print] Italy
• Vernacular Title: Tolerabilidad y efectividad del citrato de fentanilo oral transmucosa en el tratamiento a largo plazo del dolor irruptivo en pacientes oncológicos: estudio ECODIR.
• PMID: 15960932 (Publication Type: Clinical Trial, Comparative Study, English Abstract, Journal Article)

Chemical References

• Analgesics, Opioid
• Fentanyl

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Analgesics, Opioid (administration & dosage, adverse effects)
• Female
• Fentanyl (administration & dosage, adverse effects)
• Humans
• Long-Term Care
• Male
• Middle Aged
• Mouth Mucosa
• Pain Measurement (methods)
• Pain, Intractable (drug therapy)
• Safety
• Treatment Outcome