Combined oral prolonged-release oxycodone and naloxone in opioid-induced bowel dysfunction: review of efficacy and safety data in the treatment of patients experiencing chronic pain

Bibliography

• Breivik H, Collett B, Ventafridda V, Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain 2006;10:287-333
   PubMed Web of Science ®Google Scholar
• Colvin L, Forbes K, Fallon M. Difficult pain. BMJ 2006;332:1081-3
   PubMedGoogle Scholar
• Simon S. Opioids and treatment of chronic pain: understanding pain patterns and the role for rapid-onset opioids. Med Gen Med 2005;7:54
   PubMedGoogle Scholar
• Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg 2001;182:11-18S
   PubMed Web of Science ®Google Scholar
• Quigley C. Opioid switching to improve pain relief and drug tolerability. Cochrane Database Syst Rev 2004;3:CD004847
   Google Scholar
• Coluzzi F, Pappagallo M. Opioid therapy for chronic noncancer pain: practice guidelines for initiation and maintenance of therapy. Minerva Anestesiol 2005;71:425-33
   PubMedGoogle Scholar
• Cherny N, Ripamonti C, Pereira J, Strategies to manage the adverse effects of oral morphine: an evidence-based report. J Clin Oncol 2001;19:2542-54
   PubMed Web of Science ®Google Scholar
• Jordan BA, Cvejic S, Devi LA. Opioids and their complicated receptor complexes. Neuropsychopharmacology 2000;23:S5-18
   PubMed Web of Science ®Google Scholar
• Gomes I, Gupta A, Filipovska J, A role for heterodimerization of mu and delta opiate receptors in enhancing morphine analgesia. Proc Natl Acad Sci USA 2004;101:5135-9
   PubMed Web of Science ®Google Scholar
• Kurz A, Sessler DI. Opioid-induced bowel dysfunction: pathophysiology and potential new therapies. Drugs 2003;63:649-71
   PubMed Web of Science ®Google Scholar
• Holzer P. Opioids and opioid receptors in the enteric nervous system: from a problem in opioid analgesia to a possible new prokinetic therapy in humans. Neurosci Lett 2004;361:192-5
   PubMed Web of Science ®Google Scholar
• Bell T, Milanova T, Grove G, OBD symptoms impair quality of life and daily activities, regardless of frequency and duration of opioid treatment: results of a US patient survey [PROBE survey] [abstract 882]. J Pain 2007;8:S71
   Google Scholar
• Moulin DE, Iezzi A, Amireh R, Randomised trial of oral morphine for chronic non-cancer pain. Lancet 1996;347:143-7
   PubMed Web of Science ®Google Scholar
• Cook SF, Lanza L, Zhou X, Gastrointestinal side effects in chronic opioid users: results from a population-based survey. Aliment Pharmacol Ther 2008;27:1224-32
   PubMed Web of Science ®Google Scholar
• Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain 2004;112:372-80
   PubMed Web of Science ®Google Scholar
• Mundipharma GmbH. Targin®. Summary of product characteristics. Available from: http://emc.medicines.org.uk/medicine/21420/SPC/Targinact+10mg+5mg+ and+20mg+10mg+prolonged-release+tablets/ [Last accessed 2 September 2009]; http://emc.medicines.org.uk/medicine/22188/SPC/Targinact+5mg+2.5mg+ and+40mg+20mg+prolonged+release+tablets/ [Last accessed 2 September 2009]
   Google Scholar
• Cook S, Bell T, Sweeney C, Impact on quality of life of constipation-associated GI symptoms related to opioid treatment in chronic pain patients: PAC-QOL results from the opioid survey [abstract 883]. J Pain 2007;8:S71
   Google Scholar
• McMillan SC. Assessing and managing opiate-induced constipation in adults with cancer. Cancer Control 2004;11:3-9
   PubMedGoogle Scholar
• Kurz A, Sessler DI. opioid induced bowel function. Pathophysiology and potential new therapies. Drugs 2003;63:649-71
   PubMed Web of Science ®Google Scholar
• Ueberall MA, Mueller-Schwefe G. Opioid-induced constipation – a frequent and distressing side effect in daily practice affecting oral and transdermal opioid applications. Eur J Pain 2006;10:S172
   Google Scholar
• McNicol E, Horowicz-Mehler N, Fisk RA, Management of opioid side effects in cancer-related and chronic noncancer pain: a systematic review. J Pain 2003;4:231-56
   PubMed Web of Science ®Google Scholar
• Linn AJ, Steinbrook RA. Peripherally restricted mu-opioid receptor antagonists: a review. Tech Reg Anesth Pain Manag 2007;11:27-32
   Google Scholar
• Friedman JD, Dello Buono FA. Opioid antagonists in the treatment of opioid-induced constipation and pruritus. Ann Pharmacother 2001;35:85-91
   PubMed Web of Science ®Google Scholar
• Yuan CS, Foss JF, O'Connor M, Methylnaltrexone for reversal of constipation due to chronic methadone use: a randomized controlled trial. JAMA 2000;283:367-72
   PubMed Web of Science ®Google Scholar
• Yuan CS, Wei G, Foss JF, Effects of subcutaneous methylnaltrexone on morphine-induced peripherally mediated side effects: a double-blind randomized placebo-controlled trial. J Pharmacol Exp Ther 2002;300:118-23
   PubMed Web of Science ®Google Scholar
• Thomas J, Karver S, Cooney GA, Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med 2008;358:2332-43
   PubMed Web of Science ®Google Scholar
• Paulson DM, Kennedy DT, Donovick RA, Alvimopan: an oral, peripherally acting, mu-opioid receptor antagonist for the treatment of opioid-induced bowel dysfunction – a 21-day treatment-randomized clinical trial. J Pain 2005;6:184-92
   PubMed Web of Science ®Google Scholar
• Kalso E. Oxycodone. J Pain Symptom Manage 2005;29:S47-56
   PubMed Web of Science ®Google Scholar
• Nozaki C, Saitoh A, Tamura N, Kamei J. Antinociceptive effect of oxycodone in diabetic mice. Eur J Pharmacol 2005;524:75-9
   PubMed Web of Science ®Google Scholar
• Mandema JW, Kaiko RF, Oshlack B, Characterization and validation of a pharmacokinetic model for controlled-release oxycodone. Br J Clin Pharmacol 1996;42:747-56
   PubMed Web of Science ®Google Scholar
• Liu M, Wittbrodt E. Low-dose oral naloxone reverses opioid-induced constipation and analgesia. J Pain Symptom Manage 2002;23:48-53
   PubMed Web of Science ®Google Scholar
• Leow KP, Smith MT, Williams B, Cramond T. Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer. Clin Pharmacol Ther 1992;52:487-95
   PubMed Web of Science ®Google Scholar
• Gorski JC, Jones DR, Wrighton SA, Hall SD. Characterization of dextromethorphan N-demethylation by human liver microsomes. Contribution of the cytochrome P450 3A [CYP3A] subfamily. Biochem Pharmacol 1994;48:173-82
   PubMed Web of Science ®Google Scholar
• Lalovic B, Phillips B, Risler LL, Quantitative contribution of CYP2D6 and CYP3A to oxycodone metabolism in human liver and intestinal microsomes. Drug Metab Dispos 2004;32:447-54
   PubMed Web of Science ®Google Scholar
• Cleary J, Mikus G, Somogyi A, Bochner F. The influence of pharmacogenetics on opioid analgesia: studies with codeine and oxycodone in the Sprague-Dawley/Dark Agouti rat model. J Pharmacol Exp Ther 1994;271:1528-34
   PubMed Web of Science ®Google Scholar
• Lalovic B, Kharasch E, Hoffer C, Pharmacokinetics and pharmacodynamics of oral oxycodone in healthy human subjects: role of circulating active metabolites. Clin Pharmacol Ther 2006;79:461-79
   PubMed Web of Science ®Google Scholar
• Choi YS, Billings JA. Opioid antagonists: a review of their role in palliative care, focusing on use in opioid-related constipation. J Pain Symptom Manage 2002;24:71-90
   PubMed Web of Science ®Google Scholar
• Meissner W, Schmidt U, Hartmann M, Oral naloxone reverses opioid-associated constipation. Pain 2000;84:105-9
   PubMed Web of Science ®Google Scholar
• De Schepper HU, Cremonini F, Park MI, Camilleri M. Opioids and the gut: pharmacology and current clinical experience. Neurogastroenterol Motil 2004;16:383-94
   PubMed Web of Science ®Google Scholar
• Wiesen RL, Rich CR, Wang RI, Stockdale SL. The safety and value of naloxone as a therapeutic aid. Drug Alcohol Depend 1977;2:123-30
   PubMedGoogle Scholar
• van Dorp EL, Yassen A, Dahan A. Naloxone treatment in opioid addiction: the risks and benefits. Expert Opin Drug Saf 2007;6:125-32
   PubMed Web of Science ®Google Scholar
• Smith K, Hopp M, Mundin G, Single- and multiple-dose pharmacokinetic evaluation of oxycodone and naloxone in an opioid agonist/antagonist prolonged-release combination in healthy adult volunteers. Clin Ther 2008;30:2051-68
   PubMed Web of Science ®Google Scholar
• Sykes NP. An investigation of the ability of oral naloxone to correct opioid-related constipation in patients with advanced cancer. Palliat Med 1996;10:135-44
   PubMed Web of Science ®Google Scholar
• Latasch L, Zimmermann M, Eberhardt B, Treament of morphine-induced constipation with oral naloxone. Der Anaesthesist 1997;46:191-4
   PubMed Web of Science ®Google Scholar
• Culpepper-Morgan JA, Inturrisi CE, Portenoy RK, Treatment of opioid-induced constipation with oral naloxone: a pilot study. Clin Pharmacol Ther 1992;52:90-5
   PubMed Web of Science ®Google Scholar
• Thomas J. Opioid-induced bowel dysfunction. J Pain Symptom Manage 2008;35:103-13
   PubMed Web of Science ®Google Scholar
• Meissner W, Müller-Lissner, Nadstawek J, Dr. Meissner and colleagues reply to the letter to the editor from Andrew Wilcock entitled ‘prolonged-release naloxone can cause systemic opioid withdrawal'. Eur J Pain 2009; published online 31 July 2009, doi: 10.1016/j.ejpain.2009.06.005
   Google Scholar
• Meissner W, Leyendecker P, Mueller-Lissner S, A randomised controlled trial with prolonged-release oral oxycodone and naloxone to prevent and reverse opioid-induced constipation. Eur J Pain 2009;13:56-64
   PubMed Web of Science ®Google Scholar
• Nadstawek J, Leyendecker P, Hopp M, Patient assessment of a novel therapeutic approach for the treatment of severe, chronic pain. Int J Clin Pract 2008;62:1159-67
   PubMed Web of Science ®Google Scholar
• Vondrackova D, Leyendecker P, Meissner W, Analgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic pain. J Pain 2008;9:1144-54
   PubMed Web of Science ®Google Scholar
• Simpson K, Leyendecker P, Hopp M, Fixed-ratio combination oxycodone/naloxone compared with oxycodone alone for the relief of opioid-induced constipation in moderate-to-severe noncancer pain. Curr Med Res Opin 2008;24:3503-12
   PubMed Web of Science ®Google Scholar
• Löwenstein O, Leyendecker P, Hopp M, Combined prolonged-release oxycodone and naloxone improves bowel function in patients receiving opioids for moderate-to-severe non-malignant chronic pain: a randomised controlled trial. Expert Opin Pharmacother 2009;10:531-43
   PubMed Web of Science ®Google Scholar
• Meissner W, Leyendecker P, Hopp M, Long-term efficacy and safety of oxycodone and naloxone in a prolonged release fixed combination tablet in patients with moderate to severe chronic pain. World Institute of Pain, New York; 2009, A-118-0027-00784
   Google Scholar
• Mueller-Lissner S, Löwenstein O, Leyendecker P, Improved bowel function with a combination of oxycodone and naloxone [OXN] as prolonged release [PR] tablets in patients with moderate to severe chronic pain. IASP Congress on Pain, Glasgow, 17-22 August 2008. Poster PT225
   Google Scholar
• Lux EA, Leyendecker P, Kremers W, Efficacy and safety of oxycodone and naloxone in a prolonged release fixed combination tablet in elderly patients (> 65 years) with moderate to severe chronic pain. 19th IAGG Congress, Paris, 5-9 July 2009. Abstract PB7 475
   Google Scholar
• Clemens KE, Quednau I, Klaschik E. Bowel function during therapy with a combination of oxycodone/naloxone prolonged-release tablets in geriatric patients. 11th EAPC Congress, Vienna, 7-10 May 2009. Poster F317
   Google Scholar
• AM Rentz, R Yu, S Müller-Lissner, P Leyendecker. Validation of the Bowel Function Index to detect clinically meaningful changes in opioid-induced constipation. J Med Econ 2009;12:1-13
   PubMedGoogle Scholar
• Nolte T. Prolonged-release oxycodone/naloxone is effective and safe in clinical use. Palliat Med 2008;22(Suppl):399-565, poster 275
   PubMedGoogle Scholar
• Cleeland CS, Ryan KM. Pain assessment: global use of the brief pain inventory. Ann Acad Med Singapore 1994;23:129-38
   PubMedGoogle Scholar
• Handelsman L, Cochrane K, Aronson MJ, Two new rating scales for opiate withdrawal. Am J Drug Alcohol Abuse 1987;13:293-308
   PubMed Web of Science ®Google Scholar