Comparative clinical efficacy and safety of a novel controlled-release oxycodone formulation and controlled-release hydromorphone in the treatment of cancer pain

Cancer

Volumn 79, Issue 7, 1997, Pages 1428-1437

  Hagen, Neil A ^a,c   Babul, Najib ^b  

^a UNIVERSITY OF CALGARY   (Canada)

^b Purdue Frederick ^*  (Canada)

^c TOM BAKER CANCER CENTRE   (Canada)

Author keywords

cancer pain; clinical trial; controlled release; drug safety; drug treatment; hydromorphone; oxycodone

Indexed keywords

ANALGESIC AGENT; HYDROMORPH CONTIN; HYDROMORPHONE; OXYCODONE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CANCER; CANCER PAIN; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FEMALE; HUMAN; MALE; ORAL DRUG ADMINISTRATION; PAIN ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SUSTAINED RELEASE PREPARATION;

ANALGESICS, OPIOID; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DOUBLE-BLIND METHOD; DRUG EVALUATION; FEMALE; HUMANS; HYDROMORPHONE; MALE; MIDDLE AGED; NEOPLASMS; OXYCODONE; PAIN;

EID: 0030956575     PISSN: 0008543X     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1097-0142(19970401)79:7<1428::AID-CNCR21>3.0.CO;2-0     Document Type: Article

References (50)

1. Pöyhöa R, Vainio A, Kalso E. A review of oxycodone's clinical pharmacokinetics and pharmacodynamics. J Pain Symptom Manage 1993;8:63-7.
2. Kalso E, Vainio A. Morphine and oxycodone hydrochloride in the management of cancer pain. Clin Pharmacol Ther 1990;47:639-46.
3. Beaver WT, Wallenstein SL, Rogers A, Houde RW. Analgesic studies of codeine and oxycodone in patients with cancer. I. Comparisons of oral with intramuscular codeine and of oral with intramuscular oxycodone. Pharmacol Ther 1978;207:92-100.
4. Beaver WT, Wallenstein SL, Rogers A, Houde RW. Analgesic studies of codeine and oxycodone in patients with cancer. II. Comparisons of oral with intramuscular oxycodone and of oral with intramuscular morphine and codeine. Pharmacol Ther 1978;207:101-8.
5. Kaiko R, Lacouture P, Hopf K, Brown J, Goldenheim P. Analgesic onset and potency of oral controlled-release (CR) oxycodone and CR morphine [abstract]. Clin Pharmacol Ther 1996;59:130.
6. Oxycontin prescribing information. Physicians' Desk Reference (Suppl A). 50th edition Montvale, NJ: Medical Economics, 1996.
7. Kantor TG, Hopper M, Laska E. Adverse effects of commonly ordered oral narcotics. J Clin Pharmacol 1981;21:1-8.
8. Cancer pain relief and palliative care: report of a WHO Expert Committee. WHO Technical Report Series 804. Geneva: World Health Organization, 1990.
9. Hagen N, Thirlwell MP, Dhaliwal HS, Babul N, Harsanyi Z, Darke AC. Steady-state pharmacokinetics of hydromorphone and hydromorphone-3-glucuronide in cancer patients after immediate and controlled-release hydromorphone. J Clin Pharmacol 1995;35:37-44.
10. Hays H, Hagen N, Thirlwell M, Dhaliwal HS, Babul N, Harsanyi Z, et al. Comparative clinical efficacy and safety of immediate release and controlled release hydromorphone for chronic severe cancer pain. Cancer 1994;74:1808-16.
11. Jacox A, Carr DB, Payne R. New clinical-practice guidelines for the management of pain in patients with cancer. New Engl J Med 1993;330:651-5.
12. Expert Advisory Committee on the management of severe chronic severe pain in cancer patients. Cancer pain: a monograph on the management of cancer pain (Cat. No. H42-2/ 5-1984E). Ottawa, Canada: Department of National Health and Welfare, 1984; 18-29.
13. Levy MH. Pharmacologic treatment of cancer pain. New Engl Med 1996;335:1124-32.
14. MacDonald N, Der L, Allan S, Champion P. Opioid hyperexcitability: the application of alternative opioid therapy. Pain 1993;53:353-5.
15. Fainsinger R, Schoeller T, Boiskin M, Bruera E. Palliative care round: cognitive failure and coma after renal failure in a patient receiving captopril and hydromorphone. J Palliat Care 1993;9:53-5.
16. Sjogren P, Jensen NH, Jensen TS. Disappearance of morphine-induced hyperalgesia after discontinuing or substituting morphine with other opioid agonists. Pain 1994;59:313-6.
17. Bruera E, Franco JJ, Maltoni M, Watanabe S, Suarez-Almazor M. Changing pattern of agitated impaired mental status in patients with advanced cancer: association with cognitive monitoring, hydration, and opioid rotation. J Pain Symptom Manage 1995;10:287-91.
18. de Stoutz ND, Bruera E, Suarez-Almazor M. Opioid rotation for toxicity reduction in terminal cancer patients. J Pain Symptom Manage 1995;10:378-84.
19. Crews JC, Sweeney NJ, Denson DD. Clinical efficacy of methadone in patients refractory to other μ-opioid receptor agonist analgesics for management of terminal cancer pain. Cancer 1993;72:2266-72.
20. Maddocks I, Somogyi A, Abbott F, Hayball P, Parker D. Attenuation of morphine-induced delirium in palliative care by substitution with infusion of oxycodone. J Pain Symptom Manage 1996;12:182-9.
21. Dhaliwal HS, Sloan P, Arkinstall WW, Thirlwell MP, Babul N, Harsanyi Z, et al. Randomized evaluation of controlled-release codeine and placebo in cancer pain. J Pain Symptom Manage 1995;10:612-23.
22. Arkinstall WW, Sandler A, Goughnour BR, Babul N, Harsanyi Z, Darke AC. Efficacy of controlled-release codeine in chronic non-malignant pain: a randomized placebo-controlled clinical trial. Pain 1995;62:169-78.
23. Reder R, Lacouture P, Kaiko R, Fitzmartin R, Goldenheim P. Ease of titration to stable pain control in chronic pain patients with controlled-release oxycodone (Oxycontin) tablets. Proceedings of the 8th World Congress on Pain, Vancouver, British Columbia, Canada, August 17-22, 1996.
24. Sunshine A, Olsen NZ, Colon A, Rivera J, Kaiko RF, Fitzmartin R, et al. Analgesic efficacy of controlled-release oxycodone in postoperative pain. J Clin Pharmacol 1996;130:595-603.
25. Babul N, Darke AC, Hain R. Hydromorphone and metabolite pharmacokinetics in children [letter]. J Pain Symptom Manage 1995;10:335-7.
26. Bruera E, MacMillan K, Hanson J, MacDonald RN. The Edmonton staging system for cancer pain: preliminary report. Pain 1989;37:203-9.
27. Goughnour BR, Arkinstall WW, Stewart JH. Analgesic response to single and multiple doses of controlled-release morphine tablets and morphine oral solution in cancer patients. Cancer 1989;11:2294-7.
28. Thirlwell MP, Sloan PA, Maroun JA, Boos GJ, Besner J-G, Stewart JH, et al. Pharmacokinetics and clinical efficacy of oral morphine solution and controlled-release morphine tablets in cancer patients. Cancer 1989;11:2275-83.
29. Heiskanen T, Rusmaki P, Kalso E. Double-blind, randomized, repeated dose crossover comparison controlled-release oxycodone and controlled-release morphine in cancer pain. 1: Pharmacodynamic profile. Proceedings of the 8th World Congress on Pain, Vancouver, British Columbia, Canada, August 17-22, 1996.
30. Ferrell B, Wisdom C, Wenzl C, Brow J. Effects of controlled-release morphine on quality of life for cancer pain. Oncol Nurs Forum 1989;4:521-6.
31. Ross FB, Smith MT. The intrinsic antinociceptive effects of oxycodone appear to be kappa-opioid receptor mediated. Proceedings of the 8th World Congress on Pain, Vancouver, British Columbia, Canada, August 17-22, 1996.
32. Osborne RJ, Joel SP, Slevin ML. Morphine intoxication in renal failure: the role of morphine-6-glucuronide. Bri Med J 1986;292:1548-9.
33. Paterson GM, Randall CTC, Patterson J. Plasma levels of morphine and morphine glucuronides in the treatment of cancer pain: relationship to renal function and route of administration. Eur J Clin Pharmacol 1990;38:121-4.
34. Gong Q-L, Hedner J. Björkman R, Hedner T. Morphine-3-glucuronide may functionally antagonize morphine-6-glucuronide induced antinociception and ventilatory depression in the rat. Pain 1992;48:249-55.
35. Ekblom M, Gardmark M, Hannarlund-Udenaes M. Pharmacokinetics and pharmacodynamics of morphine-3-glucuronide in rats and its influence on the antinociceptive effect of morphine. Biopharm Drug Dispos 1993;14:1-11.
36. Pasternak GW, Bodnar RJ, Clark JA, Inturissi CE. Morphine-6-glucuronide, a potent mu agonist. Life Sci 1987;41:2845-9.
37. Smith MT, Watt JA, Cramond T. Morphine-3-glucuronide: a potent antagonist of morphine analgesia. Life Sci 1990; 47:579-85.
38. Yaksh TL, Harty LG, Onofrio BM. High doses of spinal morphine produce a nonopiate receptor-mediated hyperesthesia: clinical and theoretic implications. Anesthesiology 1986; 64:590-7.
39. Dale AP, Riegler FX, Albrecht RF. Ventilatory effects of fourth cerebroventricular infusions of morphine-6-or morphine-3-glucuronide in the awake dog. Anesthesiology 1989; 71:936-40.
40. Hagen NA, Foley KM, Cerbone DJ, Portenoy R, Inturrisi C. Chronic nausea associated with morphine-6-glucuronide. J Pain Symptom Manage 1991;6:125-8.
41. Hasselstrom J, Erikson S, Persson A, Rane A, Svensson JO, Sawe J. The metabolism and bioavailability of morphine in patients with severe liver cirhosis. Br J Clin Pharmacol 1990;29:289-97.
42. Weinstein SH, Gaylord JC. Determination of oxycodone in plasma and identification of a major metabolite. J Pharm Sci 1979;68:527-8.
43. Benziger DP, Cheng C, Miotto J, Grandy R. Comparative pharmacokinetics of controlled release oxycodone (Oxycontin) in special populations. Proceedings of the 8th World Congress on Pain, Vancouver, British Columbia, Canada, August 17-22, 1996.
44. Kaiko R, Grandy R, Hou Y, Benziger D. Controlled release oxycodone pharmacokinetics/pharmacodynamics in hepatic cirhosis [abstract]. Proceedings of the 14th Annual Meeting of the American Pain Society. Glenview, IL: American Pain Society, 1995; p. A-146.
45. Kaiko RF, Benziger DP, Fitzmartin RD, Burke BE, Reder RF, Goldenheim PD. Pharmacokinetic-pharmacodynamic relationships of controlled-release oxycodone. Clin Pharmacol Ther 1996;59:52-61.
46. Reder RF, Oshlack B, Miotto JB, Benziger DP, Kaiko RF. Steady-state bioavailability of controlled-release oxycodone in normal subjects. Clin Ther 1996;18:95-105.
47. Portenoy RK, Coyle N. Controversies in the long-term management of analgesic therapy with advanced cancer. J Pain Symptom Manage 1990;5:307-19.
48. Watson CPN, Babul N. Placebo-controlled evaluation of the efficacy and safety of controlled release oxycodone in postherpetic neuralgia. Proceedings of 8th World Congress on Pain, Vancouver, British Columbia, Canada, August 17-22, 1996.
49. Rowbotham M, Reisner-Keller LA, Fields HL. Both intravenous lidocaine and morphine reduce pain of postherpetic neuralgia. Neuralgia 1991;41:1024-8.
50. Portenoy RK, Foley KM, Inturrisi CE. The nature of opioid responsiveness and its implications for neuropathic pain: new hypotheses derived from studies of opioid infusions. Pain 1990;43:273-86.