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Transdermal fentanyl improves pain control and functionality in patients with osteoarthritis: an open-label Canadian trial

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Abstract

Current treatment guidelines advocate opioids for arthritis when standard analgesics produce inadequate relief. Efficacy, adverse effects (AEs), dosing regimens, physician expertise and patient preference influence treatment selection. This study assessed transdermal fentanyl (TDF) as a treatment option for osteoarthritis (OA) patients. This prospective, Canadian open-label, 8-week trial assessed the efficacy and safety of TDF in patients with OA of hip or knee with moderate-to-severe target joint pain inadequately controlled using weak opioids. TDF was initiated at 25 mcg/h and titrated to optimal pain control. Rescue acetaminophen 500 mg was allowed (maximum 4 g/day). The main endpoint was improvement in pain control assessment rating (five rating categories); pain intensity (0–10 numerical scale), functionality (WOMAC-OA Index), health-related quality of life (SF-36 Health Survey) and global impression were also evaluated. Eighty-one patients (61% female, mean age 60 years) were enrolled; 62 were evaluable. All had failed on previous weak opioid therapy, primarily codeine or codeine combinations. At treatment end, 65% rated pain control as improved (Pain Control Assessment rating change ≥1 category; p < 0.0001); mean change in pain intensity was a reduction of greater than 2 (p < 0.0001); almost 50% were maintained on TDF 25 mcg/h with less than 1.3 g/day of rescue acetaminophen. At 1 month and end of treatment, changes in the SF-36 physical global scale and individual sub-scores for the pain index and role-physical scales were highly significant (p < 0.0001). Improvement in functionality was noted at 1 month and at end of treatment with significant reductions in total WOMAC score, individual pain, stiffness and physical function sub-scores (p < 0.0001). AEs causing discontinuation (n = 32) included nausea, dizziness and vomiting. Most treatment-related AEs were mild to moderate in intensity. TDF improved pain control, functionality and health-related quality of life in these patients. The findings support current recommendations for use of opioids such as TDF as a treatment option for a sub-population of patients with OA pain.

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Acknowledgements

The FEN-OAR-401 Study Group: Dr. Christopher Atkins (Victoria), Dr. Andre Beaulieu (Sainte-Foy), Dr. William Bensen (Hamilton), Dr. Denis Choquette (Montreal), Dr. Allan Kelly (Edmonton), Dr. Majed Khraishi (St. John’s), Dr. Timothy McCarthy (Winnipeg), Dr. Brian Ramjattan (St. John’s), Dr. Jude Rodrigues (Windsor), Dr. Michel Zummer (Montreal).

Additional support from Janssen-Ortho Inc. staff: J Dinniwell (study concept and design), A Gillespie-Wight, R Chawla, J Suzuki (data monitoring),: J Sigindere, D Estaris, F Dalzilio, R Lachhman (data support), B Teixeira (editorial support).

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Authors and Affiliations

  1. Notre-Dame Hospital, Montreal, QC, Canada

    Denis Choquette

  2. Rheumatology, Manitoba Clinic, Winnipeg, MB, Canada

    Timothy G. McCarthy

  3. Rheumatology, Windsor, ON, Canada

    Jude F. N. Rodrigues

  4. Hermitage Medicentre, Edmonton, AB, Canada

    Allan J. Kelly

  5. DAMOS, Toronto, ON, Canada

    Fernando Camacho

  6. Clinical Affairs, Janssen-Ortho, Toronto, ON, Canada

    G. L. A. Horbay & Farah A. Husein-Bhabha

  7. Rheumatology Institute of Montreal, 1551 Ontario Street East, Montréal, QC, H2L 1S6, Canada

    Denis Choquette

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  1. Denis Choquette
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  3. Jude F. N. Rodrigues
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  4. Allan J. Kelly
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  6. G. L. A. Horbay
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  7. Farah A. Husein-Bhabha
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Correspondence to Denis Choquette.

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Contributors: Denis Choquette contributed to the concept and design of the study, participated in conducting the research, data analysis and co-wrote the manuscript. Fernando Camacho contributed statistical expertise to all phases of study design and data analysis and contributed to the content of the manuscript. Timothy G. McCarthy, Jude F.N. Rodrigues and Allan J. Kelly participated in conducting the research, contributed to data interpretation and to the content of the manuscript. Farah A. Husein-Bhabha coordinated the study, contributed to data analysis and manuscript preparation. G. L. A. Horbay contributed to the study design, data analysis and manuscript preparation. All authors read and approved the final manuscript.

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Choquette, D., McCarthy, T.G., Rodrigues, J.F.N. et al. Transdermal fentanyl improves pain control and functionality in patients with osteoarthritis: an open-label Canadian trial. Clin Rheumatol 27, 587–595 (2008). https://doi.org/10.1007/s10067-007-0751-6

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  • DOI: https://doi.org/10.1007/s10067-007-0751-6

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