Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: A post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial

Journal of Opioid Management

Volumn 10, Issue 5, 2014, Pages 311-322

  Nalamachu, Srinivas ^a   Hale, Martin ^b   Khan, Arif ^c,d  

^a Clinical Research   (United States)

^b Gold Coast Research LLC   (United States)

^c Northwest Clinical Research Center   (United States)

^d DUKE UNIVERSITY   (United States)

Author keywords

Hydromorphone; Low back pain; Neuropathic pain; Opioids

Indexed keywords

HYDROMORPHONE; PLACEBO;

ADULT; AGED; ANALGESIA; ARTICLE; CONSTIPATION; DIZZINESS; DOSE RESPONSE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; FATIGUE; FEMALE; HUMAN; HYPERHIDROSIS; INSOMNIA; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NAUSEA; NEUROPATHIC PAIN; NOCICEPTIVE PAIN; NUMERIC RATING SCALE; OUTCOME ASSESSMENT; PAIN INTENSITY; POST HOC ANALYSIS; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SOMNOLENCE; VOMITING; WITHDRAWAL SYNDROME; XEROSTOMIA;

EID: 84916941789     PISSN: 15517489     EISSN: 23750146     Source Type: Journal    
DOI: 10.5055/jom.20l4.0221     Document Type: Article

References (32)

1. Woolf AD, Pfleger B: Burden of major musculoskeletal conditions. Bull World Health Organ. 2003;81(9):646-656.
2. Gore M, Sadosky A, Stacey BR, et al.: The burden of chronic low back pain: Clinical comorbidities, treatment I patterns, and health care costs in usual care settings. Spine (Phila Pa 1976). 2012;37(11):E668-E677.
3. Attal N, Perrot S, Fermanian J, et al.: The neuropathic components of chronic low back pain: A prospective multicenter study using the DN4 Questionnaire. J Pain. 2011;12(10):1080-1087.
4. Yarnitsky D, Eisenberg E: Neuropathic pain: Between the positive and negative ends. Pain Forum. 1998;7(4):241-242.
5. Eisenberg E, McNicol ED, Carr DB: Efficacy and safety of opioid agonists in the treatment of neuropathic pain of nonmalignant origin: Systematic review and meta-analysis of randomized controlled trials. JAMA. 2005;293(24):3043-3052.
6. Von Hehn CA, Baron R, Woolf CJ: Deconstructing the neuropathic pain phenotype to reveal neural mechanisms. Neuron. 2012;73(4):638-652.
7. Dworkin RH, O'Connor AB, Audette J, et al.: Recommendations for the pharmacological management of neuropathic pain: An overview and literature update. Mayo Clin Proc. 2010;85(Suppl 3):S3-14.
8. Sindrup SH, Jensen TS: Efficacy of pharmacological treatments of neuropathic pain: An update and effect related to mechanism of drug action. Pain. 1999;83(3):389-400.
9. Eisenberg E, McNicol E, Carr DB: Opioids for neuropathic pain. Cochrane Database Syst Rev. 2006; (3): CD006146.
10. Huse E, Larbig W, Flor H, et al.: The effect of opioids on phantom limb pain and cortical reorganization. Pain. 2001;90(1-2):47-55.
11. Raja SN, Haythornthwaite JA, Pappagallo M, et al.: Opioids versus antidepressants in postherpetic neuralgia: A randomized, placebo-controlled trial. Neurology. 2002;59(7):1015-1021.
12. Watson CP, Moulin D, Watt-Watson J, et al.: Controlledrelease oxycodone relieves neuropathic pain: A randomized controlled trial in painful diabetic neuropathy. Pain. 2003;105(1-2):71-78.
13. Bartleson JD: Evidence for and against the use of opioid analgesics for chronic nonmalignant low back pain: A review. Pain Med. 2002;3(3):260-271.
14. Mallinckrodt Brand Pharmaceuticals: Exalgo (hydromorphone HCI) extended-release tablets [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc., 2012.
15. Hale M, Khan A, Kutch M, et al.: Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010;26(6):1505-1518.
16. Quebec Task Force on Spinal Disorders: Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine (Phila Pa 1976). 1987;12 (7 Suppl):S1-S59.
17. Hjermstad MJ, Fayers PM, Haugen DF, et al.: Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: A systematic literature review. J Pain Symptom Manage. 2011;41(6):1073-1093.
18. Roland M, Fairbank J: The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000;25(24):3115-3124.
19. Rothman M, Vallow S, Damaraju CV, et al.: Using the patient global assessment of the method of pain control to assess new analgesic modalities in clinical trials. Curr Med Res Opin. 2009;25(6):1433-1443.
20. Butler SF, Black RA, Cassidy TA, et al.: Abuse risks and routes of administration of different prescription opioid compounds and formulations. Harm Reduct J. 2011;8:29.
21. Fine PG, Mahajan G, McPherson ML: Long-acting opioids and short-acting opioids: Appropriate use in chronic pain management. Pain Med. 2009;10(Suppl 2):S79-S88.
22. Gupta S, Sathyan G: Providing constant analgesia with OROS® hydromorphone. J Pain Symptom Manage. 2007;33 (2S):S19-S24.
23. Shram MJ, Sathyan G, Khanna S, et al.: Evaluation of the abuse potential of extended release hydromorphone versus immediate release hydromorphone. J Clin Psychopharmacol. 2010;30(1):25-33.
24. Hale M, Tudor IC, Khanna S, et al.: Efficacy and tolerability of once-daily OROS hydromorphone and twice-daily extended-release oxycodone in patients with chronic, moderate to severe osteoarthritis pain: Results of a 6-week, randomized, open-label, noninferiority analysis. Clin Ther. 2007;29(5):874-888.
25. Wallace M, Skowronski R, Khanna S, et al.: Efficacy and safety evaluation of once-daily OROS hydromorphone in patients with chronic low back pain: A pilot open-label study (DO-127). Curr Med Res Opin. 2007;23(5):981-989.
26. Hanna M, Thipphawong J, 118 Study Group: A randomized, double-blind comparison of OROS® hydromorphone and controlled-release morphine for the control of chronic cancer pain. BMC Palliat Care. 2008;7:17-31
27. Binsfeld H, Szczepanski L, Waechter S, et al.: A randomized study to demonstrate noninferiority of once-daily OROS® hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010;10(5):404-415.
28. Carter NJ, Keating GM: OROS hydromorphone prolonged release: A review of its use in the management of chronic, moderate to severe pain. CNS Drugs. 2010;24(4):337-361.
29. Moulin DE, Richarz U, Wallace M, et al.: Efficacy of the sustained-release hydromorphone in neuropathic pain management: Pooled analysis of three open-label studies. J Pain Palliat Care Pharmacother. 2010;24(3):200-212.
30. Wallace M, Thipphawong J: Open-label study on the longterm efficacy, safety, and impact on quality of life of OROS hydromorphone ER in patients with chronic low back pain. Pain Med. 2010;11(10):1477-1488.
31. Nalamachu SR, Kutch M, Hale ME: Safety and tolerability of once-daily OROS® hydromorphone extended-release in opioid-tolerant adults with moderate-to-severe chronic cancer and noncancer pain: Pooled analysis of 11 clinical studies. J Pain Symptom Manage. 2012;44(6):852-865.
32. Haanpaa M, Attal N, Backonja M, et al.: NeuPSIG guidelines on neuropathic pain assessment. Pain. 2011;152(1):14-27.