Skip to main content
SpringerLink
Log in

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

  • Original Articles
  • Published:
Clinical and Translational Oncology Aims and scope Submit manuscript

Resumen

Introducción. El citrato de fentanilo oral transmucosa (CFOT) es el único fármaco desarrollado especificamente 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.

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Bibliografía

  1. Eduardo Bruera. Organizing palliative care. Cancer Strategies for the New Millennium. World Health Organization Publications. http://www.who.int/ncd/cancer/publications/abstracts/abs9810 22.html

  2. Rhiner M, Kedziera P. Managing breakthrough cancer pain: a new approach. Home Health Nurse. 1999; 17 Supl 6: Suppl 1–12:13–5.

    Google Scholar 

  3. Portenoy RK, Hagen NA. Breakthrough pain: definition and management. Oncology (Huntingt). 1989;3 Supl 8:25–9.

    CAS  Google Scholar 

  4. Portenoy RK, Hagen NA. Breakthrough pain: definition, prevalence and characteristics. Pain. 1990;41:273–81.

    Article  PubMed  CAS  Google Scholar 

  5. Caraceni A, Portenoy RK. An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International Association for the Study of Pain. Pain. 1999;82:263–74.

    Article  PubMed  CAS  Google Scholar 

  6. Zeppetella G, O’Doherty CA, Collins S. Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage. 2000;20:87–92.

    Article  PubMed  CAS  Google Scholar 

  7. Gómez-Batiste X, Madrid F, Moreno F, et al. Breakthrough cancer pain: Prevalence and characteristics in patients in Catalonia, Spain. Journal of Pain and Symptom Management. 2002;24:45–52.

    Article  PubMed  Google Scholar 

  8. Streisand JB, Varvel JR, Stanski DR, et al. Absorption and bioavailability of oral transmucosal fentanyl citrate. Anesthesiology. 1991;75:223–9.

    Article  PubMed  CAS  Google Scholar 

  9. Streisand JB, Busch MA, Egan TD, Smith BG, Gay M, Pace NL. Dose proportionality and pharmacokinetics of oral transmucosal fentanyl citrate. Anesthesiology. 1998;88:305–9.

    Article  PubMed  CAS  Google Scholar 

  10. Egan TD, Sharma A, Ashburn MA, Kievit J, Pace NL, Streisand JB. Multiple dose pharmacokinetics of oral transmucosal fentanyl citrate in healthy volunteers. Anesthesiology. 2000;92:665–73.

    Article  PubMed  CAS  Google Scholar 

  11. Farrar JT, Cleary J, Rauck R, Busch M, Nordbrock E. Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients. J Natl Cancer Inst. 1998;90:611–6.

    Article  PubMed  CAS  Google Scholar 

  12. Christie JM, Simmonds M, Patt R, et al. Dose-titration, multicenter study of oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients using transdermal fentanyl for persistent pain. J Clin Oncol. 1998;16:3238–45.

    PubMed  CAS  Google Scholar 

  13. Coluzzi PH, Schwartzberg L, Conroy JD, et al. Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). Pain. 2001;91:123–30.

    Article  PubMed  CAS  Google Scholar 

  14. Circular n.o 4/2000. Procedimientos de comunicación en materia de farmacovigilancia de medicamentos de uso humano entre la Industria Farmacéutica y la Agencia Española del Medicamento. Agencia Española del Medicamento.

  15. Notice to Marketing Authorisation Holders. Pharmacovigilance Guidelines. EMEA. January 1999.

  16. Badía X, Muriel C, Gracia A, et al. Validación española del cuestionario Brief Pain Inventory en pacientes con dolor de causa neoplásica. Med Clin. 2003;120:52–9.

    Article  Google Scholar 

  17. Pocock SJ. Clinical trials: a practical approach. 1st ed. London: John Wiley and Sons Ltd; 1983.

    Google Scholar 

  18. Zeppetella G, Ribeiro MD. Pharmacotherapy of cancer-related episodic pain. Expert Opin Pharmacother. 2003;4:493–502.

    Article  PubMed  CAS  Google Scholar 

  19. Fortner BV, Okon TA, Portenoy RK. A survey of pain related hospitalisations, emergency department visits, and physician office visits reported by cancer patients with and without history of breakthrough pain. The Journal of Pain. 2002;3:38–44.

    Article  PubMed  Google Scholar 

  20. Caraceni A, Martini C, Zecca E, Portenoy RK, Working Group of an IASP Task Force on cancer pain. Breakthrough pain characteristics and syndromes in patients with cancer pain. An international survey. Palliative Medicine. 2004;18:177–83.

    Article  PubMed  Google Scholar 

  21. Mercadante S, Radbruch L, Caraceni A, et al; Steering Committee of the European Association for Palliative Care (EAPC) Research Network. Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care. Cancer. 2002;94:832–9.

    Article  PubMed  Google Scholar 

  22. Collin SL, Faura CC, Moor RA, McQuay HJ. Peak plasma concentrations after oral morphine: a systematic review. J Pain Symptom Manage. 1998;16:388–402.

    Article  Google Scholar 

  23. Hanks GW, Conno F, Cherny N, et al. Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer. 2001;84:587–93.

    Article  PubMed  CAS  Google Scholar 

  24. Payne R, Coluzzi P, Hart L, et al. Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain. J Pain Symptom Manage. 2001;22(1):575–83.

    Article  PubMed  CAS  Google Scholar 

  25. Trelis J, Pérez-Hernández C, Sánchez-Domínguez F, Martínez Calderón F, Gracia A, Zsolt I. Citrato de fentanilo oral transmucoso en el tratamiento del dolor irruptivo en pacientes con cáncer en España: resultados del estudio EDIPAD. Rev Soc Esp Dolor. 2004;11:184–96.

    Google Scholar 

  26. Portenoy RK. Tolerance to opioid analgesics: clinical aspects. Cancer Surv. 1994;21:49–65.

    PubMed  CAS  Google Scholar 

  27. Jaranson DE, Ryan KM, Gilson AM, Dahl JL. Trends in medical use and abuse of opioid analgesics. JAMA. 2000;283:1710–4.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Servicio de Oncología Médica, Hospital Universitario 12 de Octubre, Avda. Córdoba km 4,500, 28045, Madrid

    Vicente Valentín Maganto

  2. Servicio de Oncología Médica, Hospital General Universitario, Valencia

    Carlos Camps Herrero

  3. Servicio de Oncología Médica, Hospital Vall Hebrón, Barcelona

    Joan Carulla Torrent

  4. Servicio de Oncología Médica, Hospital General de Guadalajara, Guadalajara

    Javier Cassinello Espinosa

  5. Servicio de Oncología Médica, Hospital Nuestra Señora de Candelaria, Sta. Cruz de Tenerife

    Javier Dorta Delgado

  6. Servicio de Oncologia Médica, Fundación Hospital Alcorcón, Madrid

    Carlos Jara Sánchez

  7. Servicio de Oncología Médica, Hospital Virgen del Rocío, Sevilla

    José Andrés Moreno Nogueira

Authors
  1. Vicente Valentín Maganto
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Carlos Camps Herrero
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Joan Carulla Torrent
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Javier Cassinello Espinosa
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Javier Dorta Delgado
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Carlos Jara Sánchez
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. José Andrés Moreno Nogueira
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Vicente Valentín Maganto.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Maganto, V.V., Herrero, C.C., Torrent, J.C. et al. Tolerabilidad y efectividad del citrato de fentanilo oral transmucosa en el tratamiento a largo plazo del dolor irruptivo en pacientes oncológicos: estudio ECODIR. Clin Transl Oncol 7, 205–212 (2005). https://doi.org/10.1007/BF02712818

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Issue Date:

  • DOI: https://doi.org/10.1007/BF02712818

Palabras clave

Key words

Search

Navigation