Transdermal fentanyl for the treatment of pain caused by osteoarthritis of the knee or hip: an open, multicentre study

Xavier Le Loët, Karel Pavelka, Ute Richarz, Xavier Le Loët, Karel Pavelka, Ute Richarz

Abstract

Background: This study was designed to evaluate the utility of transdermal fentanyl (TDF, Durogesic) for the treatment of pain due to osteoarthritis (OA) of the knee or hip, which was not adequately controlled by non-opioid analgesics or weak opioids. The second part of the trial, investigating TDF in patients with rheumatoid arthritis (RA) is reported separately.

Methods: Current analgesia was optimised during a 1-week run-in. Patients then received 28 days treatment with TDF starting at 25 microg/hr, with the option to increase the dose until adequate pain control was achieved. Metoclopramide was taken during the first week and then as needed.

Results: Of the 159 patients recruited, 75 with OA knee and 44 with OA hip completed the treatment phase, 30 knee and 18 hip patients entered the one-week taper-off phase. The most frequently used maximum dose of TDF was 25 microg/hr. The number of patients with adequate pain control increased during the run-in period from 4% to 27%, and further increased during TDF treatment to 88% on day 28. From baseline to endpoint, there were significant reductions in pain (p < 0.001) and improvements in functioning (p < 0.001) and physical (p < 0.001) and mental (p < 0.05) health. Scores for 'pain right now' decreased significantly within 24 hours of starting TDF treatment. TDF was assessed favourably and 84% of patients would recommend it for OA-related pain. Nausea and vomiting were the most common adverse events (reported by 32% and 26% of patients respectively), despite prophylaxis with metoclopramide, which showed limited efficacy in this setting.

Conclusion: TDF significantly increased pain control, and improved functioning and quality of life. Metoclopramide appeared to be of limited value in preventing nausea and vomiting; more effective anti-emetic treatment may enable more people to benefit from strong opioids such as TDF. This study suggests that four weeks is a reasonable period to test the benefit of adding TDF to improve pain control in OA patients and that discontinuing therapy in cases of limited benefit creates no major obstacles.

Figures

Figure 1
Figure 1
Patient disposition.
Figure 2
Figure 2
Pain control assessment.

References

    1. Lawrence JS, Bremner JM, Bier F. Osteoarthritis, prevalence in the population and relationship between symptoms and X-ray changes. Ann Rheum Dis. 1966;25:1–24.
    1. Arthritis Research Campaign Factfile – arthritis at a glance. 2003.
    1. Creamer P, Flores R, Hochberg MC. Management of osteoarthritis in older adults. Clin Geriatr Med. 1998;14:435–454.
    1. Pham T, van der Heijde D, Lassere M, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30:1648–1654.
    1. Anon . Arthritis Rheum. Vol. 43. American College of Rheumatology Subcommittee on Osteoarthritis; 2000. Recommendations of the medical management of osteoarthritis of the hip and knee: 2000 update; pp. 1905–1915.
    1. Roth SH, Reder RF. The role of opioids in the treatment of osteoarthritis. Resident Staff Physician. 1998;44:31–36.
    1. Wolheim FA. Current pharmacological treatment of osteroarthritis. Drugs. 1996;52:27–38.
    1. Pinals RS. Mechanism of joint destruction, pain and disability in osteoarthritis. Drugs. 1996;52:14–20.
    1. American Pain Society Guideline for the management of pain in osteoarthritis, rheumatoid arthritis, and juvenile chronic arthritis. 2002.
    1. Kalso E, Allan L, Dellemijn PLI, Faura CC, Ilias WK, Jensen TS, Perrot S, Plaghki LH, Zenz M. Recommendations for using opioids in chronic non-cancer pain. Eur J Pain. 2003;7:381–386. doi: 10.1016/S1090-3801(02)00143-X.
    1. Schug SA, Merry AF, Acland RH. Treatment principles for the use of opioids in pain of nonmalignant origin. Drugs. 1991;42:228–239.
    1. Graziotti PJ, Goucke CR. The use of oral opioids in patients with chronic non-cancer pain. Management strategies. Med J Aust. 1997;167:30–34.
    1. Anon The use of opioids for the treatment of chronic pain: a consensus statement from the American Academy of Pain Medicine and the American Pain Society. Pain Forum. 1997;6:77–79.
    1. Jeal W, Benfield P. Transdermal fentanyl: a review of its pharmacological properties and therapeutic efficacy in pain control. Drugs. 1997;53:109–138.
    1. Simpson RK, Edmondson EA, Constant CF, Collier C. Transdermal fentanyl as treatment for chronic low back pain. J Pain Symptom Manage. 1997;14:218–224. doi: 10.1016/S0885-3924(97)00183-8.
    1. Allan L, Hays H, Jensen NH, de Waroux BL, Bolt M, Donald R, Kalso E. Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ. 2001;322:1154–1158. doi: 10.1136/bmj.322.7295.1154.
    1. Milligan K, Lanteri-Minet M, Borchert K, Helmers H, Donald R, Kress HG, Adriaensen H, Moulin D, Jarvimaki V, Haazen L. Evaluation of long term efficacy and safety of transdermal fentanyl in the treatment of chronic non-cancer pain. J Pain. 2001;2:197–204. doi: 10.1054/jpai.2001.25352.
    1. Ringe JD, Faber H, Bock O, Valentine S, Felsenberg D, Pfeifer M, Minne HW, Schwalen S. Transdermal fentanyl for the treatment of back pain caused by vertebral osteoporosis. Rheumatol Int. 2002;22:199–203. doi: 10.1007/s00296-002-0193-z.
    1. Peloso PM, Bellamy N, Bensen W, Thompson GT, Harsanyi Z, Babul N, Darke AC. Double blind randomized placebo control trial of controlled release codeine in the treatment of osteoarthritis of the knee or hip. J Rheumatol. 2000;27:764–771.
    1. Caldwell JR, Hale ME, Boyd RE, Hague JM, Iwam T, Shi M, Lacouture PG. Treatment of osteoarthritis pain with controlled release oxycodone or fixed combination oxycodone plus acetaminophen added to nonsteroidal anti-inflammatory drugs: a double blind, randomized, multicentre, placebo controlled trial. J Rheumatol. 1999;26:862–869.
    1. Caldwell JR, Rapoport RJ, Davis JC, Offenberg HL, Marker HW, Roth SH, Yuan W, Eliot L, Babul N, Lynch PM. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002;23:278–291. doi: 10.1016/S0885-3924(02)00383-4.
    1. Theodoridis T, Waap I, Schwalen S, Kramer J. Fentanyl in the treatment of pain caused by arthrosis. Z Orthop. 2002;140:217–222.
    1. Bierma-Zeinstra S, Bohnen A, Ginai A, Prins A, Verhaar J. Validity of the American College of Rheumatology criteria for diagnosing hip osteoarthritis in primary care research. J Rheumatol. 1999;26:1129–1133.
    1. Bellamy N, Bradley LA. Workshop on chronic pain, pain control, and patient outcomes in rheumatoid arthritis and osteoarthritis. Arthritis Rheum. 1996;39:357–362.
    1. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129–138.
    1. Ware JE, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36) Med Care. 1992;30:473–483.
    1. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation Study of WOMAC: A health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the knee or hip. J Rheumatology . 1988;15:1833–1840.
    1. Gillings D, Koch G. The application of the principle of intention-to-treat to the analysis of clinical trials. Drug Inform J. 1991;25:411–424.
    1. Allan L, Simpson K, Slappendel R. Transdermal fentanyl versus sustained release oral morphine in strong-opioid naïve patients with chronic low back pain. Spine. 2005.
    1. Ahmedzai S, Brooks D. Transdermal fentanyl versus sustained release oral morphine in cancer pain: preference, efficacy and quality of life. J Pain Symptom Manage. 1997;13:254–261. doi: 10.1016/S0885-3924(97)00082-1.
    1. Dellemijn PLI, van Duijn H, Vanneste JAL. Prolonged treatment with transdermal fentanyl in neuropathic pain. J Pain Symptom Manage. 1998;16:220–229. doi: 10.1016/S0885-3924(98)00070-0.
    1. Knott L. Treating osteoarthritis in practice – the TOP study. Curr Med Res Opin. 2000;16:147–152. doi: 10.1185/030079900542858.
    1. Portenoy RK. Current pharmacotherapy of chronic pain. J Pain Symptom Manage. 2000;19:S16–S20. doi: 10.1016/S0885-3924(99)00124-4.

Source: PubMed

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