Low doses of transdermal fentanyl in opioid-naive patients with cancer pain

Abstract

Objective:

The aim of this study was to evaluate the effect and tolerability of low doses of transdermal (TD) fentanyl patches in opioid-naive patients with cancer pain.

Methods:

This was a nonrandomized, open-label, uncontrolled study in fifty consecutive opioid-naive patients with advanced cancer and moderate pain. TD fentanyl was initiated at a dose of 12 µg/h. Doses were then adjusted according to the clinical response. Pain intensity, opioid-related adverse effects, TD fentanyl doses, and quality of life were monitored over 4 weeks. The time to dose stabilization and indexes of dose escalation were also calculated.

Results:

Thirty-one patients completed all 4 weeks of the study. Pain control was achieved within a mean of 1.7 days after the start of TS fentanyl therapy. Significant differences in TD fentanyl doses were observed during the study period (P = 0.03). Mean doses were doubled 4 weeks after starting the treatment. The level of adverse effects was acceptable in most patients and only a minority of patients discontinued the treatment (13.8%).

Conclusion:

Low doses of TD fentanyl were well tolerated and effective. Observations from this study suggest that randomized, controlled, double-blind studies of TD fentanyl 12 µg/h in opioid-naive patients with cancer pain may be warranted.

Key words::

• Cancer pain
• Opioids
• Trandermal fentanyl

Transparency

Declaration of funding

There was no funding for this paper. There are no publication fees from sponsors for this study, and no financial or other relationships exist. The authors take full responsibility for the views expressed in this article.

Declaration of financial/other relationships

Prof. Mercadante received fees for advisory boards or lectures from the following companies: Pfizer, Sanofi-Aventis, Janssen, Grunenthal, Mundipharma, Cephalon, Qx Pharma, GwPharma, Prostrakan, Nycomed and Dompè.