Transdermal opioids for cancer pain control in patients with renal impairment

Authors

  • Giuseppe Melilli, MD
  • Boaz Gedaliahu Samolsky Dekel, MD, PhD, MA
  • Catia Frenquelli, MD
  • Rita Mellone, MD
  • Franco Pannuti, MD

DOI:

https://doi.org/10.5055/jom.2014.0197

Keywords:

renal impairment, transdermal, buprenorphine, fentanyl, cancer pain

Abstract

Objectives: As guidelines for opioid use in renal-impaired patients with cancer are limited, the authors sought to assess the efficacy, safety, and tolerability, of transdermal buprenorphine for moderate/severe cancer pain in renal-impaired outpatients.

Methods: In a prospective parallel-group active-controlled study, n = 42 consecutively recruited outpatients with or without renal impairment (serum creatinine >=1.3 or <=1.2 mg/dL, respectively) were treated with transdermal buprenorphine (group BUP) or fentanyl (group FEN), respectively. Patients were followed up, at home, by the nonprofit ANT-Italia-foundation physicians in Bologna, Italy. Measurements at 10 (T1), 30 (T2), and 90 (T3) days after enrollment (T0) were pain intensity (Numerical Rating Scale [NRS]), Karnofski score, opioid dose (µg/h), rescue-dose consumption, and occurrence of adverse effects. Patients recorded subjective measurements in a personal diary. Upon data analysis, investigators were blinded to the patient group.

Results: At T0, in groups BUP and FEN, median NRS score was 8.0 (CI, 7.4-8.4); its reduction over time (T3; NRS = 3.0; CI, 2.1-3.8 and 2.0-4.0, respectively) was significant and constant in both groups (t-test; T0-T1, T1-T2, and T2-T3; p < 0.0001, p < 0.001, and p < 0.05, respectively). At all times, there were no significant differences in pain scores between the groups. In all evaluations, adverse effects were reported n = 73/126 times (60.8 percent) and showed no significant association (χ2, p > 0.05) with the study groups.

Conclusions: Transdermal buprenorphine, in outpatients with cancer and renal impairment, is as effective, safe, and tolerable as fentanyl in patients without such impairment. These results add further evidence to the notion that buprenorphine, with its peculiar pharmacokinetics, may be an appropriate choice for opioid treatment in patients with renal impairment.

Author Biographies

Giuseppe Melilli, MD

ANT Italia Onlus Foundation, Bologna, Italy

Boaz Gedaliahu Samolsky Dekel, MD, PhD, MA

Department of Medical and Surgery Sciences, University of Bologna, Bologna, Italy

Catia Frenquelli, MD

ANT Italia Onlus Foundation, Bologna, Italy

Rita Mellone, MD

ANT Italia Onlus Foundation, Bologna, Italy

Franco Pannuti, MD

ANT Italia Onlus Foundation, Bologna, Italy

References

Boger RH: Renal impairment: A challenge for opioid treatment? The role of buprenorphine. Palliat Med. 2006; 20(Suppl 1): s17-s23.

Mercadante S, Arcuri E: Opioids and renal function. J Pain. 2004; 5(1): 2-19.

Murphy EJ: Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Anaesth Intensive Care. 2005; 33(3): 311-322.

King S, Forbes K, Hanks GW, et al.: A systematic review of the use of opioid medication for those with moderate to severe cancer pain and renal impairment: A European Palliative Care Research Collaborative opioid guidelines project. Palliat Med. 2011; 25(5): 525-552.

Dean M: Opioids in renal failure and dialysis patients. J Pain Symptom Manage. 2004; 28(5): 497-504.

Davis MP: Twelve reasons for considering buprenorphine as a frontline analgesic in the management of pain. J Support Oncol. 2012; 10(6): 209-219.

Filitz J, Griessinger N, Sittl R, et al.: Effects of intermittent hemodialysis on buprenorphine and norbuprenorphine plasma concentrations in chronic pain patients treated with transdermal buprenorphine. Eur J Pain. 2006; 10(8): 743-748.

Pergolizzi J, Aloisi AM, Dahan A, et al.: Current knowledge of buprenorphine and its unique pharmacological profile. Pain Pract. 2010; 10(5): 428-450.

Bennett WM, Aronoff GR, Morrison G, et al.: Drug prescribing in renal failure: Dosing guidelines for adults. Am J Kidney Dis. 1983; 3(3): 155-193.

Hand CW, Sear JW, Uppington J, et al.: Buprenorphine disposition in patients with renal impairment: Single and continuous dosing, with special reference to metabolites. Br J Anaesth. 1990; 64(3): 276-282.

Pergolizzi J, Boger RH, Budd K, et al.: Opioids and the management of chronic severe pain in the elderly: Consensus statement of an International Expert Panel with focus on the six clinically most often used World Health Organization Step III opioids (buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone). Pain Pract. 2008; 8(4): 287-313.

Cachia E, Ahmedzai SH: Transdermal opioids for cancer pain. Curr Opin Support Palliat Care. 2011; 5(1): 15-19.

Caraceni A, Hanks G, Kaasa S, et al.: Use of opioid analgesics in the treatment of cancer pain: Evidence-based recommendations from the EAPC. Lancet Oncol. 2012; 13(2): e58-e68.

Husler J, Wernecke K: How to design trials/studies. In Zbinden AM, Thompson D (eds.): Conducting Research in Anaesthesia and Intensive Care Medicine. Oxford: Butterworth-Heinemann, 2001: 97-138.

European Medicines Agency: Choice of Control Group in Clinical Trials. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdf. Accessed July 4, 2013.

Aapro M, Launay-Vacher V: Importance of monitoring renal function in patients with cancer. Cancer Treat Rev. 2012; 38(3): 235-240.

Hanks GW, Conno F, Cherny N, et al.: Morphine and alternative opioids in cancer pain: The EAPC recommendations. Br J Cancer. 2001; 84(5): 587-593.

Wong NA, Jones HW: An analysis of discharge drug prescribing amongst elderly patients with renal impairment. Postgrad Med J. 1998; 74(873): 420-422.

Bower S: Plasma protein binding of fentanyl: The effect of hyperlipoproteinaemia and chronic renal failure. J Pharm Pharmacol. 1982; 34(2): 102-106.

Davies G, Kingswood C, Street M: Pharmacokinetics of opioids in renal dysfunction. Clin Pharmacokinet. 1996;31(6):410-422.

Elkader A, Sproule B: Buprenorphine: Clinical pharmacokinetics in the treatment of opioid dependence. Clin Pharmacokinet. 2005; 44(7): 661-680.

Deng J, St Clair M, Everett C, et al.: Buprenorphine given after surgery does not alter renal ischemia/reperfusion injury. Comp Med. 2000; 50(6): 628-632.

Hudson JQ, Nyman HA: Use of estimated glomerular filtration rate for drug dosing in the chronic kidney disease patient. Curr Opin Nephrol Hypertens. 2011; 20(5): 482-491.

Published

03/01/2014

How to Cite

Melilli, MD, G., B. G. Samolsky Dekel, MD, PhD, MA, C. Frenquelli, MD, R. Mellone, MD, and F. Pannuti, MD. “Transdermal Opioids for Cancer Pain Control in Patients With Renal Impairment”. Journal of Opioid Management, vol. 10, no. 2, Mar. 2014, pp. 85-93, doi:10.5055/jom.2014.0197.