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Oral-transmukosales Fentanylcitrat zur Therapie von Durchbruchschmerzen

Ergebnisse einer nichtinterventionellen Studie (NIS)

Oral transmucosal fentanyl citrate for the treatment of breakthrough pain

Results of a non-interventional study (NIS)

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Zusammenfassung

Hintergrund

Eine neue Applikationsform eines Opioids, oral-transmukosales Fentanylcitrat (OTFC), wurde hinsichtlich Wirksamkeit und Verträglichkeit bei Patienten mit Durchbruchschmerzen, deren chronische Tumorschmerzen bereits mit Opioiden als Erhaltungstherapie behandelt werden, in einer nichtinterventionellen Studie (NIS) untersucht.

Patienten und Methoden

An der prospektiven multizentrischen Beobachtungsstudie nahmen 406 Patienten teil. Über 3–4 Monate wurde die Wirksamkeit von OTFC zur Behandlung von Durchbruchschmerzen anhand der numerischen analogen Schmerzskala (NAS) dokumentiert. Weiterhin wurden die Therapie mit OTFC bewertet und unerwünschte Arzneimittelwirkungen aufgezeichnet.

Ergebnisse

Durch die Behandlung mit OTFC sank die Schmerzintensität im Median von NAS 8 zu Beginn auf eine Schmerzintensität von NAS 2 bei Abschluss der Studie. Im Median wurde dazu eine Dosis OTFC von 400 μg angewendet. Die Verträglichkeit wurde von 87,5% der Patienten als gut oder sehr gut bewertet.

Schlussfolgerungen

Oral-transmukosales Fentanylcitrat ist zur Behandlung von Durchbruchschmerzen bei chronischen Tumorschmerzen wirksam und gut verträglich.

Abstract

Background

In a non-interventional study the efficacy and tolerability of oral transmucosal fentanyl citrate (OTFC) was studied in patients with opioid-treated cancer pain suffering from breakthrough pain.

Patients and methods

The prospective multicenter observational trial included 406 patients. For 3–4 months, efficacy of OTFC treatment for breakthrough pain was documented using a numerical analog pain intensity scale (NAS). Further, OTFC therapy was rated and adverse events were recorded.

Results

With application of oral transmucosal fentanyl citrate median pain intensity fell from NAS 8 points at the beginning to NAS 2 points at the end of the study. The median effective dosage was 400 g. Tolerability was rated as good or very good by 87.5% of the patients.

Conclusion

Oral transmucosal fentanyl citrate is a safe and effective treatment for breakthrough pain in chronic cancer-related pain.

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Literatur

  1. Aronoff GM, Brennan MJ, Pritchard DD, Ginsberg B (2005) Evidence-based oral transmucosal fentanyl citrate (OTFC) dosing guidelines. Pain Med 6: 305–314

    Article  PubMed  Google Scholar 

  2. Arzneimittelkommission der deutschen Ärzteschaft (2007) Empfehlungen zur Therapie von Tumorschmerzen. Arznei Praxis 34: 1–32

    Google Scholar 

  3. Christie JM, Simmonds M, Patt R et al. (1998) 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 16: 3238–3245

    PubMed  CAS  Google Scholar 

  4. Coluzzi PH (1998) Cancer pain management: newer perspectives on opioids and episodic pain. Am J Hosp Palliat Care 15: 13–22

    Article  PubMed  CAS  Google Scholar 

  5. Coluzzi PH, Schwartzberg L, Conroy JD et al. (2001) Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). Pain 91: 123–130

    Article  PubMed  CAS  Google Scholar 

  6. Farrar JT, Cleary J, Rauck R et al. (1998) Oral transmucosal fentanyl citrate: randomized, double-blinded, placebo-controlled trial for treatment of breakthrough pain in cancer patients. J Natl Cancer Inst 90: 611–616

    Article  PubMed  CAS  Google Scholar 

  7. Hanks GW, Conno F, Cherny N et al. (2001) Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer 84: 587–593

    Article  PubMed  CAS  Google Scholar 

  8. Hanks GW, Nugent M, Higgs CM, Busch MA (2004) Oral transmucosal fentanyl citrate in the management of breakthrough pain in cancer: an open, multicentre, dose-titration and long-term use study. Palliat Med 18: 698–704

    Article  PubMed  CAS  Google Scholar 

  9. Hanks G, Portenoy R, MacDonald N, Forbes K (1998) Difficult pain problems. In: Doyle D, Hanks G, MacDonald N (eds) Oxford textbook of palliative medicine. Oxford University Press, Oxford, pp 454–477

  10. Lichtor JL, Sevarino FB, Joshi GP et al. (1999) The relative potency of oral transmucosal fentanyl citrate compared with intravenous morphine in the treatment of moderate to severe postoperative pain. Anesth Analg 89: 732–738

    Article  PubMed  CAS  Google Scholar 

  11. McMenamin E, Farrar JT (2002) OTFC: a novel agent for breakthrough pain related to cancers. Expert Rev Neurother 2: 625–629

    Article  CAS  Google Scholar 

  12. Mercadante S, Radbruch L, Caraceni A et al. (2002) Episodic (breakthrough) pain: consensus conference of an expert working group of the European Association for Palliative Care. Cancer 94: 832–839

    Article  PubMed  Google Scholar 

  13. Payne R, Coluzzi P, Hart L et al. (2001) Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain. J Pain Symptom Manage 22: 575–583

    Article  PubMed  CAS  Google Scholar 

  14. Portenoy RK, Hagen NA (1990) Breakthrough pain: definition, prevalence and characteristics. Pain 41: 273–281

    Article  PubMed  CAS  Google Scholar 

  15. Portenoy RK, Hagen NA (1991) Breakthrough pain: definition and manifestations. Prim Care Cancer: 27–33

    Google Scholar 

  16. Portenoy RK, Payne D, Jacobsen P (1999) Breakthrough pain: characteristics and impact in patients with cancer pain. Pain 81: 129–134

    Article  PubMed  CAS  Google Scholar 

  17. Portenoy RK, Payne R, Coluzzi P et al (1999) Oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough pain in cancer patients: a controlled dose titration study. Pain 79: 303–312

    Article  PubMed  CAS  Google Scholar 

  18. Radbruch L, Nauck F (2002) Morphin und andere Opioide in der Tumorschmerztherapie. Die Empfehlungen der EAPC. Schmerz 16: 186–193

    Article  PubMed  CAS  Google Scholar 

  19. Rees E (2002) The role of oral transmucosal fetanyl citrate in the management of breakthrough cancer pain. Int J Palliat Nurs 8: 304–308

    PubMed  Google Scholar 

  20. Streisand JB, Busch MA, Egan TD et al (1998) Dose proportionality and pharmacokinetics of oral transmucosal fentanyl citrate. Anesthesiology 88: 305–309

    Article  PubMed  CAS  Google Scholar 

  21. Streisand JB, Varvel JR, Stanski DR et al (1991) Absorption and bioavailability of oral transmucosal fentanyl citrate. Anesthesiology 75: 223–229

    Article  PubMed  CAS  Google Scholar 

  22. Svendsen KB, Andersen S, Arnason S et al (2005) Breakthrough pain in malignant and non-malignant diseases: a review of prevalence, characteristics and mechanisms. Eur J Pain 9: 195–206

    Article  PubMed  Google Scholar 

  23. Taylor DR, Webster LR, Chun SY et al (2007) Impact of breakthrough pain on quality of life in patients with chronic, noncancer pain: patient perceptions and effect of treatment with oral transmucosal fentanyl citrate (OTFC, ACTIQ). Pain Med 8: 281–288

    Article  PubMed  Google Scholar 

  24. Vainio A, Auvinen A (1996) Prevalence of symptoms among patients with advanced cancer: an international collaborative study. Symptom Prevalence Group. J Pain Symptom Manage 12: 3–10

    Article  PubMed  CAS  Google Scholar 

  25. Zeppetella G, O’Doherty CA, Collins S (2001) Prevalence and characteristics of breakthrough pain in cancer patients admitted to a hospice. J Pain Symptom Manage 20: 87–92

    Article  Google Scholar 

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Danksagung

Wir danken allen beteiligten Ärztinnen und Ärzten, die zur Datenerhebung beigetragen haben.

Interessenkonflikt

Der korrespondierende Autor gibt an, dass kein Interessenkonflikt besteht. Die nichtinterventionelle Studie wurde von der Cephalon GmbH gesponsert.

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Authors and Affiliations

  1. Abt. Anästhesie und Intensivmedizin, Zollernalb-Klinikum,Akademisches Lehrkrankenhaus der Universität Tübingen, Tübinger Str. 20/3 , 72336, Balingen, Deutschland

    R. Zarth

  2. Praxis für Schmerztherapie und Palliativmedizin, Freiburg, Freiburg, Deutschland

    M. Ehmer

  3. Spezielle Schmerztherapie/Palliativmedizin , MVZ Buntenskamp, Geesthacht, Geesthacht, Deutschland

    H.-B. Sittig

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  1. R. Zarth
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  2. M. Ehmer
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  3. H.-B. Sittig
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Correspondence to R. Zarth.

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Zarth, R., Ehmer, M. & Sittig, HB. Oral-transmukosales Fentanylcitrat zur Therapie von Durchbruchschmerzen. Schmerz 21, 545–552 (2007). https://doi.org/10.1007/s00482-007-0590-z

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