Clinical Drug Investigation

, Volume 29, Supplement 1, pp 17–23 | Cite as

Standard Therapy with Opioids in Chronic Pain Management

ORTIBER Study
  • Antonio Gatti
  • Carlo Reale
  • Roberto Occhioni
  • Marta Luzi
  • Alessandra Canneti
  • Claudia De Polo
  • Martina Gubernari
  • Massimo Mammucari
  • Alessandro Fabrizio Sabato
Original Research Article Part 1: Pain Management in the Clinical Setting

Abstract

Objective: Moderate to severe pain is commonly experienced by cancer and non-cancer patients. Although opioids are generally the most important drugs in chronic pain management, their use in Italy remains low. We designed a prospective open trial to assess the efficacy and safety of a standard therapy clinically available for a large range of patients.

Methods: A total of 172 consecutive patients (89 women and 83 men) with chronic pain (daily mean visual analogue scale (VAS) score > 4) that was not adequately managed by their existing pain regimen were enrolled to receive an immediate release (IR) dose of morphine: 30 mg/day (opioid-naive patients) or 60 mg/day (non-naive patients) for 5 days. After this period (start therapy), all patients were switched to slow release (SR) opioid therapy for 30 days (steady therapy). Each breakthrough pain (BTP) episode was treated with a single dose of IR morphine (20% of the daily dose) during all study periods.

Results: Daily VAS score was reduced from 7.4 ± 1.3 at baseline to 3.8 ± 1.5 (p < 0.0001) after 30 days of steady therapy in cancer and non-cancer patients. Fewer patients reported BTP events by study end (55% of patients with BTP at basal time had no BTP at last follow up), and the number of daily BTP events experienced by patients was reduced by therapy to 1–2 per day in 75% of patients reporting BTP. Further, the time delay to reach pain relief following administration of a rescue dose of IR morphine was 15 minutes or less in 52.1% of patients at study end. The standard therapy was well tolerated and fewer adverse effects were recorded at the end of the study period compared with baseline, with the exception of constipation, which showed a moderate increase (from 18.2% to 25.0%).

Conclusion: Start therapy with IR morphine followed by conversion to SR opioid therapy could be implemented as a standard therapy to manage moderate to severe chronic pain in patients with cancer or non-cancer pain. ORamorph® in TIBER study (ORTIBER).

Notes

Acknowledgements

This study received no external funding, and the authors have no potential conflicts of interest that are directly relevant. English language assistance for the preparation of this manuscript was provided by Rod McNab, Wolters Kluwer Health Medical Communications. This assistance was funded by Molteni Farmaceutici, Inc. The authors thank Ennio Sarli for data analysis.

References

  1. 1.
    Von Korff M, Lin EH, Fenton JJ, et al. Frequency and priority of pain patients’ health care use. Clin J Pain 2007; 23(5): 400–8CrossRefGoogle Scholar
  2. 2.
    Blyth FM, March LM, Brnabic AJ, et al. Chronic pain and frequent use of health care. Pain 2004; 111(1–2): 51–8PubMedCrossRefGoogle Scholar
  3. 3.
    Goudas LC, Bloch R, Gialeli-Goudas M, et al. The epidemiology of cancer pain. Cancer Invest 2005; 23(2): 182–90PubMedCrossRefGoogle Scholar
  4. 4.
    Payne R. Recognition and diagnosis of breakthrough pain. Pain Med 2007; 8(1): s3–7PubMedCrossRefGoogle Scholar
  5. 5.
    Hanks GW, Conno F, Cherny N, et al. Morphine and alternative opioids in cancer pain: the EAPC recommendations. Br J Cancer 2001; 84(5): 587–93PubMedCrossRefGoogle Scholar
  6. 6.
    Roggeri D, Saramin C, Terrazzani G, et al. Resource consumption and costs of treating pain in patients affected by cancer in a district of northeast Italy. Pharmacol Res 2007; 56(4): 329–34PubMedCrossRefGoogle Scholar
  7. 7.
    Bernabei R, Gambassi G, Lapane K, et al. Management of pain in elderly patients with cancer. SAGE Study Group. Systematic Assessment of Geriatric Drug Use via Epidemiology. JAMA. 1998; 279(23): 1877–82PubMedCrossRefGoogle Scholar
  8. 8.
    Dickman A, Ellershaw J. NSAIDs: gastroprotection or selective COX-2 inhibitor? Palliat Med 2004; 18(4): 275–86PubMedCrossRefGoogle Scholar
  9. 9.
    DeConno F, Ripamonti C, Fagnoni E, et al. The Merito Study: a multicenter trial of the analgesic effect and tolerability of the normal-release oral morphine during titration phase in patients with cancer pain. Palliat Med 2008; 22(3): 214–21PubMedCrossRefGoogle Scholar
  10. 10.
    Mercadante S. Opioid titration in cancer pain: a critical review. Eur J Pain 2007; 11(8): 823–30PubMedCrossRefGoogle Scholar
  11. 11.
    Wells N, Murphy B, Douglas S, et al. Establishing the safety and efficacy of an opioid titration protocol. J Opioid Manag 2005; 1(1): 41–8PubMedGoogle Scholar
  12. 12.
    Bruera E, Pereira J, Watanabe S, et al. Opioid rotation in patients with cancer pain. A retrospective comparison of dose ratios between methadone, hydromorphone, and morphine. Cancer 1996; 78(4): 852–7PubMedCrossRefGoogle Scholar
  13. 13.
    Indelicato RA, Portenoy RK. Opioid rotation in the management of refractory cancer pain. J Clin Oncol 2003; 21(9 Suppl.): 87s–91sPubMedCrossRefGoogle Scholar
  14. 14.
    Indelicato RA, Portenoy RK. Opioid rotation in the management of refractory cancer pain. J Clin Oncol 2002; 20(1): 348–52PubMedGoogle Scholar
  15. 15.
    Portenoy RK. Managing cancer pain poorly responsive to systemic opioid therapy. Oncology (Williston Park) 1999; 13(5 Suppl. 2): 25–9Google Scholar
  16. 16.
    deStoutz ND, Bruera E, Suarez-Almazor M. Opioid rotation for toxicity reduction in terminal cancer patients. J Pain Symptom Manage 1995; 10(5): 378–84PubMedCrossRefGoogle Scholar
  17. 17.
    Smith HS. Variations in opioid responsiveness. Pain Physician 2008; 11(2): 237–48PubMedGoogle Scholar
  18. 18.
    Kadiev E, Patel V, Rad P, et al. Role of pharmacogenetics in variable response to drugs: focus on opioids. Expert Opin Drug Metab Toxicol 2008; 4(1): 77–91PubMedCrossRefGoogle Scholar
  19. 19.
    Somogyi AA, Barratt DT, Coller JK. Pharmacogenetics of opioids. Clin Pharmacol Ther 2007; 81(3): 429–44PubMedCrossRefGoogle Scholar
  20. 20.
    Mercadante S, Radbruch L, Caraceni A, et al. Episodic (breakthrough) pain. Consensus conference of an expert working group of the European Association for Palliative Care. Cancer 2002; 94(3): 832–9PubMedCrossRefGoogle Scholar
  21. 21.
    World Health Organization. WHO’s pain ladder [online]. Available from URL: http://www.who.int/cancer/palliative/painladder/en/ [Accessed 2009 Apr 1]Google Scholar

Copyright information

© Adis Data Information BV 2009

Authors and Affiliations

  • Antonio Gatti
    • 1
  • Carlo Reale
    • 2
  • Roberto Occhioni
    • 3
  • Marta Luzi
    • 2
  • Alessandra Canneti
    • 2
  • Claudia De Polo
    • 1
  • Martina Gubernari
    • 1
  • Massimo Mammucari
    • 4
  • Alessandro Fabrizio Sabato
    • 1
  1. 1.Anaesthesiology and Intensive Care Medicine DepartmentUniversity of Tor VergataRomeItaly
  2. 2.University “La Sapienza”Institute of Anaesthesiology, Resuscitation and Pain TherapyRomeItaly
  3. 3.Anaesthesiology DepartmentAzienda Ospedaliera S. Camillo-ForlaniniRomeItaly
  4. 4.Medical Advisor of Anaesthesiology and Intensive Care Medicine DepartmentUniversity of Tor VergataRomeItaly

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