A pooled analysis of patient-specific factors and efficacy and tolerability of tapentadol extended release treatment for moderate to severe chronic pain

Journal of Opioid Management

Volumn 9, Issue 5, 2013, Pages 343-356

  Etropolski, Mila ^a   Lange, Bernd ^b   Goldberg, Jutta ^b   Steup, Achim ^b   Rauschkolb, Christine ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b GRÜNENTHAL GMBH   (Germany)

Author keywords

Baseline pain intensity; BMI; Chronic pain; Gender; Low back pain; Opioid experience; Osteoarthritis pain; Tapentadol

Indexed keywords

OPIATE; OXYCODONE; PARACETAMOL; PLACEBO; TAPENTADOL;

ARTICLE; BODY MASS; CHRONIC PAIN; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG TOLERABILITY; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; HYPERHIDROSIS; INSOMNIA; KNEE OSTEOARTHRITIS; KNEE PAIN; LOW BACK PAIN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RETROSPECTIVE STUDY; SOMNOLENCE; TERTIARY CARE CENTER; VOMITING; XEROSTOMIA;

EID: 84891313110     PISSN: 15517489     EISSN: None     Source Type: Journal    
DOI: 10.5055/jom.2013.0177     Document Type: Article

References (47)

1. Adams EH, Chwiecko P, Ace-Wagoner Y, et al.: A study of AVINZA (morphine sulfate extended-release capsules) for chronic moderate-to-severe noncancer pain conducted under real-world treatment conditions-The ACCPT study. Pain Pract. 2006; 6(4): 254-264. (Pubitemid 44920925)
2. Caldwell JR, Rapoport RJ, Davis JC, et al.: 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(4): 278-291. (Pubitemid 34462941)
3. Coluzzi F, Mattia C: Oxycodone. Phannacological profile and clinical data in chronic pain management. Minerva Anestesiol. 2005; 71(7-8): 451-460. (Pubitemid 43932971)
4. 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. (Pubitemid 47223433)
5. Hale ME, Fleischmann R, Salzman R, et al.: Efficacy and safety of controlled-release versus immediate-release oxycodone: Randomized, double-blind evaluation in patients with chronic back pain. Clin J Pain. 1999; 15(3): 179-183. (Pubitemid 29467548)
6. Hale ME, Dvergsten C, Gimbel J: Efficacy and safety of oxymorphone extended release in chronic low back pain: Results of a randomized, double-blind, placebo- and active-controlled phase III study. J Pain. 2005; 6(1): 21-28. (Pubitemid 40051998)
7. Hale ME, Ahdieh H, Ma T, et al.: Efficacy and safety of OPANA ER (oxymorphone extended release) for relief of moderate to severe chronic low back pain in opioid-experienced patients: A 12-week, randomized, double-blind, placebo-controlled study. J Pain. 2007; 8(2): 175-184. (Pubitemid 46186162)
8. Katz N, Rauck R, Ahdieh H, et al.: A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain. Curr Med Res Opin. 2007; 23(1): 117-128. (Pubitemid 46191677)
9. Mcilwain H, Ahdieh H: Safety, tolerability, and effectiveness of oxymorphone extended release for moderate to severe osteoarthritis pain: A one-year study. Am J Ther. 2005; 12(2): 106-112.
10. Taylor R Jr, Raffa RB, Pergolizzi JV Jr: Controlled release formulation of oxycodone in patients with moderate to severe chronic osteoarthritis: A critical review of the literature. J Pain Res. 2012; 5: 77-87.
11. Devulder J, Richarz U, Nataraja SH: Impact of long-term use of opioids on quality of life in patients with chronic, non-malignant pain. Curr Med Res Opin. 2005; 21(10): 1555-1568.
12. Furlan AD, Sandoval JA, Mailis-Gagnon A, et al.: Opioids for chronic noncancer pain: A meta-analysis of effectiveness and side effects. CMAJ. 2006; 174(11): 1589-1594. (Pubitemid 43829515)
13. Kalso E, Edwards JE, Moore RA, et al.: Opioids in chronic non-cancer pain: Systematic review of efficacy and safety. Pain. 2004; 112(3): 372-380. (Pubitemid 39550738)
14. Attal N, Cruccu G, Baron R, et al.: EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010; 17(9): 1113-1e88.
15. Papaleontiou M, Henderson CR Jr, Turner BJ, et al.: Outcomes associated with opioid use in the treatment of chronic noncancer pain in older adults: A systematic review and meta-analysis. J Am Geriatr Soc. 2010; 58(7): 1353-1369.
16. Moore RA, Mcquay HJ: Prevalence of opioid adverse events in chronic non-malignant pain: Systematic review of randomised trials of oral opioids. Arthritis Res Ther. 2005; 7(5): R1046-R1051.
17. Swegle JM, Logemann C: Management of common opioid-induced adverse effects. Am Fam Physician. 2006; 74(8): 1347-1354. (Pubitemid 44607306)
18. Bell T, Annunziata K, Freedman D, et al.: Opioid-induced constipation increases healthcare resource use and impairs work productivity: Comparison with other patient groups with and without constipation. J Pain. 2007; 8(4 suppl 1): S75; Abstract 897.
19. Bell TJ, Panchal SJ, Miaskowski C, et al.: The prevalence, severity, and impact of opioid-induced bowel dysfunction: Results of a US and European Patient Survey (PROBE 1). Pain Med. 2009; 10(1): 35-42.
20. Austrup ML, Korean G: Analgesic agents for the postoperative period. Opioids. Surg Clin North Am. 1999; 79(2): 253-273. (Pubitemid 29205380)
21. Cepeda MS, Farrar JT, Baumgarten M, et al.: Side effects of opioids during short-term administration: Effect of age, gender, and race. Clin Pharmacol Ther. 2003; 74(2): 102-112. (Pubitemid 36951807)
22. Cherny NI: Opioid analgesics: Comparative features and prescribing guidelines. Drugs. 1996; 51(5): 713-737.
23. Peniston JH, Gould E: Oxymorphone extended release for the treatment of chronic low back pain: A retrospective pooled analysis of enriched-enrollment clinical trial data stratified according to age, sex, and prior opioid use. Clin Ther. 2009; 31(2): 347-359.
24. Hurley RW, Adams MC: Sex, gender, and pain: An overview of a complex field. Anesth Analg. 2008; 107(1): 309-317.
25. Ziegler D, Pritchett YL, Wang F, et al.: Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007; 30(3): 664-669. (Pubitemid 46354350)
26. Averbuch M, Katzper M: Severity of baseline pain and degree of analgesia in the third molar post-extraction dental pain model. Anesth Analg. 2003; 97(1): 163-7; Table.
27. Irizarry MC, Webb DJ, Ali Z, et al.: Predictors of placebo response in pooled lamotrigine neuropathic pain clinical trials. Clin J Pain. 2009; 25(6): 469-476.
28. Zhang W, Robertson J, Jones AC, et al.: The placebo effect and its determinants in osteoarthritis: Meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008; 67(12): 1716-1723.
29. Lloret Linares C, Decleves X, Oppert JM, et al.: Pharmacology of morphine in obese patients: Clinical implications. Clin Pharmacokinet. 2009; 48(10): 635-651.
30. Cheymol G: Effects of obesity on pharmacokinetics implications for drug therapy. Clin Pharmacokinet. 2000; 39(3): 215-231.
31. Hanley MJ, Abernethy DR, Greenblatt DJ: Effect of obesity on the pharmacokinetics of drugs in humans. Clin Pharmacokinet. 2010; 49(2): 71-87.
32. Patanwala AE, Holmes KL, Erstad BL: Analgesic response to morphine in obese and morbidly obese patients in the emergency department. Emerg Med J. 2013.
33. Roland CL, Setnik B, Cleveland JM, et al.: Clinical outcomes during opioid titration following initiation with or conversion to Remoxy®, an extended-release formulation of oxycodone. Postgrad Med. 2011; 123(4): 148-159.
34. Tzschentke TM, Christoph T, Kögel B, et al.: ((-)-(1R,2R)-3-(3- Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): A novel m-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther. 2007; 323(1): 265-276. (Pubitemid 47443277)
35. Tzschentke TM, De Vry J, Terlinden R, et al.: Tapentadol hydrochloride. Drugs Future. 2006; 31(12): 1053-1061.
36. Schroder W, Tzschentke TM, Terlinden R, et al.: Synergistic interaction between the two mechanisms of action of tapentadol in analgesia. J Pharmacol Exp Ther. 2011; 337(1): 312-320.
37. Afilalo M, Etropolski MS, Kuperwasser B, et al.: Efficacy and safety of tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: A randomized, double-blind, placebo- and active-controlled phase III study. Clin Drug Investig. 2010; 30(8): 489-505.
38. Wild JE, Grond S, Kuperwasser B, et al.: Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010; 10(5): 416-427.
39. Buynak R, Shapiro DY, Okamoto A, et al.: Efficacy and safety of tapentadol extended release for the management of chronic low back pain: Results of a prospective, randomized, double-blind, placebo- and active-controlled phase III study. Expert Opin Pharmacother. 2010; 11(11): 1787-1804.
40. Schwartz S, Etropolski M, Shapiro DY, et al.: Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: Results of a randomized-withdrawal, placebo-controlled trial. Curr Med Res Opin. 2011; 27(1): 151-162.
41. Gálvez R, Schäfer M, Hans G, et al.: Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: Results of an open-label, phase IIIb study. Adv Ther. 2013; 30(3): 229-259.
42. Steigerwald I, Sprunken A, Lahne U, et al.: Effectiveness of tapentadol prolonged release (PR) and equipotency of tapentadol PR compared with World Health Organization step III opioids in patients with severe, chronic osteoarthritis knee pain. Poster presented at the 10th Annual American Society of Regional Anesthesia and Pain Medicine (ASRA) Pain Meeting & Workshops, New Orleans, LA, November 17-20, 2011.
43. Steigerwald I, Muller M, Kujawa J, et al.: Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: Results of an open-label, phase 3b study. J Pain Res. 2012; 5: 121-138.
44. Steigerwald I, Muller M, Davies A, et al.: Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: Results of an open-label, phase 3b study. Curr Med Res Opin. 2012; 28(6): 911-936.
45. Lange B, Kuperwasser B, Okamoto A, et al.: Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain. Adv Ther. 2010; 27(6): 381-399.
46. World Health Organization: Global Database On Body Mass Index: BMI Classification. Available at http://apps.who.int/bmi/index.jsp?introPage=intro- 3.html. Accessed January 4, 2011.
47. Hauschke D, Pigeot I: Establishing efficacy of a new experimental treatment in the 'gold standard' design. Biom J. 2005; 47(6): 782-786. (Pubitemid 43037324)