Journal of Pain and Symptom Management
Volume 40, Issue 2 , Pages 266-278 , August 2010

A Randomized, Double-Blind, Double-Dummy Comparison of the Efficacy and Tolerability of Low-Dose Transdermal Buprenorphine (BuTrans® Seven-Day Patches) With Buprenorphine Sublingual Tablets (Temgesic®) in Patients With Osteoarthritis Pain

  • Ian G.V. James, MBChB, DCH, DRCOG

      Affiliations

    • Spring House Surgery, Bolton, Lancashire, United Kingdom
    • ,
  • Catherine M. O'Brien, MSc

      Affiliations

    • Fincham Statistics, King's Lynn, Norfolk, United Kingdom
    • ,
  • Chris J. McDonald, MBBS, MRCOphth, FFPM

      Affiliations

    • Medical Services and Pharmacovigilance, Napp Pharmaceuticals Limited, Cambridge, United Kingdom
    • Corresponding Author InformationAddress correspondence to: Chris J McDonald, MB, BS, Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, United Kingdom.

,Accepted 12 January 2010.

References 

  1. Likar R, Kayser H, Sittl R. Long-term management of chronic pain with transdermal buprenorphine: a multicenter, open-label, follow-up study in patients from three short-term clinical trials. Clin Ther. 2006;28:943–952
  2. Bach V, Kamp-Jensen M, Jensen N-H, Eriksen J. Buprenorphine and sustained release morphine—effect and side-effects in chronic use. Pain Clin. 1991;4:87–93
  3. De , Conno F, Ripamonti C, Sbanotto A, et al. A clinical study on the use of codeine, oxycodone, dextropropoxyphene, buprenorphine, and pentazocine in cancer pain. J Pain Symptom Manage. 1991;6:423–427
  4. Nasar MA, McLeavy MA, Knox J. An open study of sub-lingual buprenorphine in the treatment of chronic pain in the elderly. Curr Med Res Opin. 1986;10:251–255
  5. Adriaensen H, Mattelaer B, Vanmeeden H. A long-term open, clinical and pharmacokinetic assessment of sublingual buprenorphine in patients suffering from chronic pain. Acta Anaesthiol Belg. 1985;36:33–40
  6. Blamey SL, Finlay IG, Carter DC, Imrie CW. Analgesia in acute pancreatitis: comparison of buprenorphine and pethidine. BMJ. 1984;288:1494–1495
  7. Ventafridda V, De Conno F, Guarise G, Tamburini M, Savio G. Chronic analgesic study on buprenorphine action in cancer pain. Arzneimittelforschung. 1983;33:587–590
  8. Masson AHB. Sublingual buprenorphine versus oral dihydrocodeine in post-operative pain. J Int Med Res. 1981;9:506–510
  9. Huang P, Kehner GB, Cowan A, et al. Comparison of pharmacological activities of buprenorphine and norbuprenorphine: norbuprenorphine is a potent opioid agonist. J Pharmacol Exp Ther. 2001;297:688–695
  10. Cowan A, Friderichs E, Staßburger , et al. Basic pharmacology of buprenorphine. In:  Budd K,  Raffa RB editor. Buprenorphine—the unique opioid analgesic. New York: Thieme; 2005;p. 3–21
  11. Ide S, Minami M, Satoh M, et al. Buprenorphine antinociception is abolished, but naloxone-sensitive reward is retained, in μ-opioid receptor knockout mice. Neuropsychopharmacology. 2004;29:1656–1663
  12. Brainin-Mattos J, Smith ND, Malkmus S, et al. Cancer-related bone pain is attenuated by a systemically available δ-opioid receptor agonist. Pain. 2006;122:174–181
  13. Dahan A, Yassen A, Bijl H, et al. Comparison of the respiratory effects of intravenous buprenorphine and fentanyl in humans and rats. Br J Anaesth. 2005;94:825–834
  14. Dahan A, Yassen A, Romberg R, et al. Buprenorphine induces ceiling in respiratory depression but not in analgesia. Br J Anaesth. 2006;96:627–632
  15. Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994;55:569–580
  16. Boas RA, Villiger JW. Clinical actions of fentanyl and buprenorphine. The significance of receptor binding. Br J Anaesth. 1985;57:192–196
  17. Villiger JW, Taylor KM. Buprenorphine: characteristics of binding sites in the rat central nervous system. Life Sci. 1981;29:2699–2708
  18. Romero DV, Partilla JS, Zheng QX, et al. Opioid peptide receptor studies. 12. Buprenorphine is a potent and selective mu/kappa antagonist in the [35S]-GTP-gamma-S functional binding assay. Synapse. 1999;34:83–94
  19. Kearney PM, Baigent C, Godwin J, et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006;332:1302–1308
  20. Goldstein JL. Challenges in managing NSAID-associated gastrointestinal tract injury. Digestion. 2004;69:25–33
  21. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343:1520–1528
  22. Bullingham RE, McQuay HJ, Dwyer D, Allen MC, Moore RA. Sublingual buprenorphine used postoperatively: clinical observations and preliminary pharmacokinetic analysis. Br J Clin Pharmacol. 1981;12:117–122
  23. Langford R, McKenna F, Ratcliffe S, Vojtassák J, Richarz U. Transdermal fentanyl for improvement of pain and functioning in osteoarthritis: a randomized, placebo-controlled trial. Arthritis Rheum. 2006;54:1829–1837
  24. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129–138
  25. 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 hip or knee. J Rheumatol. 1988;15:1833–1840
  26. 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 following total knee or hip arthroplasty in osteoarthritis. J Orthopaed Rheumatol. 1988;1:95–108
  27. Potts RO, Lobo RA. Transdermal drug delivery: clinical considerations for the obstetrician-gynecologist. Obstet Gynecol. 2005;105:953–961
  28. Burris JF, Papademetriou V, Wallin JD, Cook ME, Weidler DJ. Therapeutic adherence in the elderly: transdermal clonidine compared to oral verapamil for hypertension. Am J Med. 1991;91:22S–28S
  29. Cano A. Compliance to hormone replacement therapy in menopausal women controlled in a third level academic centre. Maturitas. 1994;20:91–99
  30. Allan L, Hays H, Jensen NH, et al. Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. BMJ. 2001;322:1154–1158
  31. Heel RC, Brogden RN, Speight TM, Avery GS. Buprenorphine: a review of its pharmacological properties and therapeutic efficacy. Drugs. 1979;17:81–110
  32. Reidenberg B, Eltahtawy A, Munera C, et al. Daily pharmacokinetic performance of a buprenorphine transdermal system (BTDS) for up to 7 days [abstract]. Proceedings of the 30th Annual American College of Clinical Pharmacy Meeting, October 18–21, 2009, Anaheim, California, p. 1027.
  33. 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
  34. Gana TJ, Pascual MLG, Fleming RRB, et al. Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Curr Med Res Opin. 2006;22:1391–1401
  35. Babul N, Noveck R, Chipman H, et al. Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee. J Pain Symptom Manage. 2004;28:59–71
  36. Peloso PM, Bellamy N, Bensen W, et al. Double blind randomized placebo control trial of controlled release codeine in the treatment of osteoarthritis of the hip or knee. J Rheumatol. 2000;27:764–771
  37. Katz N. Methodological issues in clinical trials of opioids for chronic pain. Neurology. 2005;65:S32–S49
  38. Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary care. Ann Rheum Dis. 2001;60:91–97
  39. Medicines and Healthcare products Regulatory Agency . Cardiovascular safety of non-steroidal anti-inflammatory drugs: Overview of key data. London, UK: MHRA; 2005;
  40. Langman MJ, Weil J, Wainwright P, et al. Risks of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. Lancet. 1994;343:1075–1078
  41. Cepeda MS, Camargo F, Zea C, Valencia L. Tramadol for osteoarthritis. Cochrane Database Syst Rev. 2006;3:CD005522
  42. Cone EJ, Gorodetzky CW, Yousefnejad D, Darwin WD. 63Ni electron-capture gas chromatographic assay for buprenorphine and metabolites in human urine and feces. J Chromatogr. 1985;337:291–300
  43. Polettini A, Huestis MA. Simultaneous determination of buprenorphine, norbuprenorphine, and buprenorphine-glucuronide in plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B Biomed Sci Appl. 2001;754:447–459
  44. Moulin DE, Max MB, Kaiko RF, et al. The analgesic efficacy of intrathecal D-Ala2-D-Leu5-enkephalin in cancer patients with chronic pain. Pain. 1985;23:213–221
  45. Onofrio BM, Yaksh TL. Intrathecal delta-receptor ligand produces analgesia in man. [letter] Lancet. 1983;1:1386–1387
  46. Jensen ML, Foster D, Upton R, et al. Comparison of cerebral pharmacokinetics if buprenorphine and norbuprenorphine in an in vivo sheep model. Xenobiotica. 2007;37:441–457
  47. Baba M, Oishi R, Saeki K. Enhancement of blood-brain barrier permeability to sodium fluoroscein by stimulation of μ opioid receptors in mice. Naunyn-Schmiedeberg's Arch Pharmacol. 1988;337:423–428
  48. Landau CJ, Carr WD, Razzetti AJ, et al. Buprenorphine transdermal delivery system in adults with persistent noncancer-related pain syndromes who require opioid therapy: a multicenter, 5-week run-in and randomized, double-blind maintenance-of-analgesia study. Clin Ther. 2007;31:2179–2193
  49. Spyker DA, Hale ME, Lederman M, et al. Long-term use of buprenorphine transdermal system (BTDS) in patients with chronic pain. [abstract] J Am Geriatr Soc. 2002;50(Suppl 4):S66
  50. Conaghan P, Schofield JP, O'Brien C. A head-to-head comparison of BuTrans® (buprenorphine transdermal patches) versus co-codamol in elderly patients with severe hip and knee osteoarthritis [abstract]. Annual European Congress of Rheumatology, June 11–14, 2008, Paris, France.

 This trial was sponsored by Napp Pharmaceuticals Limited, United Kingdom.

PII: S0885-3924(10)00324-6

doi: 10.1016/j.jpainsymman.2010.01.013

Journal of Pain and Symptom Management
Volume 40, Issue 2 , Pages 266-278 , August 2010

Article Tools

* Image Usage & Resolution