Tapentadol for chronic musculoskeletal pain in adults

Cochrane Database of Systematic Reviews

Volumn 2015, Issue 5, 2015, Pages

  Santos, João ^a   Alarcão, Joana ^a   Fareleira, Filipa ^a   Vaz Carneiro, António ^a   Costa, João ^b  

^a HOSPITAL DE SANTA MARIA   (Portugal)

^b INSTITUTO DE MEDICINA MOLECULAR   (Portugal)

Author keywords

[No Author keywords available]

Indexed keywords

OXYCODONE; PLACEBO; TAPENTADOL; NARCOTIC ANALGESIC AGENT; PHENOL DERIVATIVE;

ADULT DISEASE; CHRONIC PAIN; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FATIGUE; FOLLOW UP; GASTROINTESTINAL DISEASE; HEADACHE; HUMAN; INSOMNIA; KNEE OSTEOARTHRITIS; LOW BACK PAIN; MUSCULOSKELETAL PAIN; NAUSEA; NEUROLOGIC DISEASE; NUMERIC RATING SCALE; PAIN INTENSITY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK REDUCTION; SOMNOLENCE; SYSTEMATIC REVIEW; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VOMITING; XEROSTOMIA; ADULT; META ANALYSIS; OSTEOARTHRITIS, KNEE;

ADULT; ANALGESICS, OPIOID; CHRONIC PAIN; CLINICAL TRIALS, PHASE III AS TOPIC; HUMANS; LOW BACK PAIN; MUSCULOSKELETAL PAIN; OSTEOARTHRITIS, KNEE; OXYCODONE; PHENOLS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84940984616     PISSN: 14651858     EISSN: None     Source Type: Journal    
DOI: 10.1002/14651858.CD009923.pub2     Document Type: Review

References (66)

1. Afilalo M, Etropolski MS, Kuperwasser B, Kelly K, Okamoto A, Van Hove I, 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. Clinical Drug Investigation 2010;30(8):489-505.
2. Afilalo M, Kuperwasser B, Kelly K, Okamoto A, Van Hove I, Lange B, et al. Efficacy and safety of tapentadol extended release (ER) for chronic pain due to osteoarthritis of the knee: results of a phase 3 study. Pain Practice 2009;9(s1):159.
3. Etropolski M, Lange B, Kuperwasser B, Kelly K, Okamoto A, Steup A, et al. Efficacy and safety of tapentadol extended release versus oxycodone controlled release in opioid-naive and opioid-experienced patients with chronic pain associated with osteoarthritis of the knee. Osteoarthritis and Cartilage 2009;17:S175.
4. Kavanagh S, Ashworth J, Lange B, Etropolski MS, Van Hove I, Rauschkolb C. EuroQol-5 dimension health status questionnaire results from a randomized, double-blind, placebo-and active-controlled Phase 3 study of tapentadol extended release (ER) for the management of chronic osteoarthritis knee pain. Value Health 2009;12(7):A433-4.
5. Kelly K, Etropolski M, Kuperwasser B, Okamoto A, Steup A, Van Hove, et al. Similar analgesic effect and improved tolerability of tapentadol extended release (ER) versus oxycodone controlled release (CR) for treatment of chronic osteoarthritis (OA) knee pain: results from a randomized, double-blind, phase 3 trial. Rheumatology 2010;49:i79.
6. Kelly K, Greene A, Kuperwasser B, McCann B, Lange B, Steup A, et al. Effects of tapentadol extended release on the Western Ontario and McMaster universities osteoarthritis index (WOMAC) and pain intensity in patients with chronic osteoarthritis pain: results of a randomized, phase 3, active-and placebo-controlled study. Arthritis and Rheumatism 2009;60:850.
7. Kelly K, Kuperwasser B, Okamoto A, Van Hove I, Häufel T, Lange B, et al. Efficacy and gastrointestinal tolerability of tapentadol extended release in a randomized, double-blind, placebo-and active-controlled study in patients with moderate-to-severe chronic osteoarthritis knee pain. Pain Practice 2009;9(S1):161-2.
8. Kuperwasser B, Häufel T, Kelly K, Etropolski M, Laschewski F, Okamoto A, et al. Incidence and severity of gastrointestinal treatment-emergent adverse events in patients treated with tapentadol extended release (ER) or oxycodone controlled release (CR) for relief of chronic osteoarthritis knee pain. Osteoarthritis and Cartilage 2009;17:S178.
9. Rauschkolb C, Lange B, Kuperwasser B, Kelly K, Okamoto A, Van Hove I, et al. Tapentadol extended release for the relief of chronic osteoarthritis knee pain: results from the EuroQol-5 dimension (EQ-5D) and Western Ontario and McMaster Universities osteoarthritis index (WOMAC) questionnaires. Osteoarthritis and Cartilage 2009;17:S179.
10. Afilalo M, Morlion B. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician 2013;16(1):27-40.
11. Etropolski M, Lange B, Goldberg J, Steup A, Rauschkolb C. 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 2013;9(5):343-56.
12. Merchant S, Provenzano D, Mody S, Ho KF, Etropolski M. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. Journal of Opioid Management 2013;9(1):51-61.
13. Buynak R, Etropolski M, Lange B, Shapiro D, Douglas Y, Okamoto A, et al. Dose stability of tapentadol ER for the relief of chronic low back pain: results of a randomized, active-and placebo-controlled study. Arthritis and Rheumatism 2009;60:1494.
14. Buynak R, Shapiro D, Okamoto A, Lange C, Etropolski M. Efficacy, safety, and gastrointestinal tolerability of tapentadol ER in a randomized, double-blind, placebo-and active-controlled phase III study of patients with chronic low back pain. Journal of Pain 2009;1:S48.
15. Buynak R, Shapiro D, Okamoto A, Van Hove I, Etropolski M. Efficacy and safety of tapentadol ER for chronic low back pain: results of a randomized, double-blind, placebo-and active-controlled phase III study. Journal of Pain 2009;1:S50.
16. Buynak R, Shapiro D, Okamoto A, Van Hove I, Rauschkolb C, Steup 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 Opinion on Pharmacotherapy 2010;11(11):1787-804.
17. Buynak R, Shapiro DY, Okamoto A, Van Hove I, Rauschkolb C, Steup A, et al. Erratum: 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 Opinion on Pharmacotherapy (2010) 11(11): 1787-804). Expert Opinion on Pharmacotherapy 2010;11(16):2773.
18. Etropolski M, Rauschkolb-Loffler C, Shapiro D, Okamoto A, Lange C. A randomized, double-blind, placebo-and active-controlled phase III study of tapentadol ER for chronic low back pain: analysis of efficacy endpoint sensitivity. Journal of Pain 2009;1:S51.
19. Etropolski MS, Shapiro D, Leslie H, Okamoto A, Van Hove I, Lange C, et al. Analysis of efficacy and safety of tapentadol extended release (ER) for chronic low back pain based on prior opioid experience. European Journal of Pain 2009;13:S203-4.
20. Kavanagh S, Lange B, Ashworth J, Etropolski M, McNeill M, Rauschkolb C. Tapentadol extended release (ER) for chronic low back pain: results of EuroQol-5 dimension (EQ-5D) and Short Form-36 (SF-36) health status questionnaires. Value in Health 2009;12(7):A376.
21. Shapiro D, Buynak R, Okamoto A, Van Hove I, Steup A, Lange B, et al. Results of a randomized, double-blind, placebo-and active-controlled trial of tapentadol extended release for chronic low back pain. Rheumatology 2010;49:i78-9.
22. Biondi D, Xiang J, Lange R, Etropolski M, Vorsanger G, Moskovit B. Safety and tolerability of tapentadol extended release (ER) versus oxycodone controlled release (CR) in elderly patients with chronic low back or osteoarthritis pain. Journal of Pain 2010;1:S42.
23. Biondi D, Xiang J, Lange R, Etropolski M, Vorsanger G, Moskovitz B. Tapentadol extended release (ER) versus oxycodone controlled release (CR) for management of chronic low back or osteoarthritis pain: Analyses of study discontinuations due to constipation, nausea, or vomiting. Journal of Pain 2010;1:S42.
24. Biondi D, Xiang J, Vorsanger G, Moskovitz B, Ashworth J, Etropolski M. Tapentadol extended release (ER) versus oxycodone controlled release (CR) for management of chronic low back or osteoarthritis pain: Influence of prior opioid experience on study discontinuations due to constipation, nausea, or vomiting. Journal of Pain 2010;1:S42.
25. Blondi D, Xiang J, Lange R, Etropolski M, Vorsanger G, Moskovitz B. Tolerability of tapentadol extended release versus oxycodone controlled release in elderly patients with chronic low back or osteoarthritis pain in a 1-year safety study. Der Schmerz 2010;24(S1):92.
26. Grond S, Kuperwasser B, McCann B, Etropolski M, Lange R, Lange B, et al. Dose stability of tapentadol extended release and oxycodone controlled release in a one-year, randomized, open-label, phase 3 safety trial in patients with chronic low back or osteoarthritis pain. Osteoarthritis and Cartilage 2009;17:S181-2.
27. Grond S, Kuperwasser B, McCann B, Etropolski M, Lange R, Lange B, et al. Long-term safety and gastrointestinal tolerability of tapentadol extended release or oxycodone controlled release in patients with chronic low back or osteoarthritis pain. Arthritis and Rheumatism 2009;60:1495.
28. Weber H, Lange R, Kuperwasser B, McCann B, Okamoto A, Steup A, et al. Tolerability of tapentadol extended release (ER) based on discontinuations because of adverse events in patients with moderate to severe chronic pain: results of a 1-year randomized phase 3 safety study. Rheumatology 2010;49:i78.
29. Weber H, Lange R, Kuperwasser B, McCann B, Okamoto A, Steup A, et al. Tolerability of tapentadol extended release (ER) based on discontinuations because of adverse events in patients with moderate-to-severe chronic pain. European Journal of Pain 2009;13:S205.
30. Wild J, Grond S, Kuperwasser B, Gilbert J, McCann B, Lange B, et al. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Practice 2010;10(5):416-27.
31. Ashworth J, Kuperwasser B, Etropolski M, Lange B, Lange R, Häufel T. Assessment of opioid withdrawal in patients treated with tapentadol prolonged release during an open-label extension study. Osteoarthritis and Cartilage 2010;18:S148.
32. Kuperwasser B, McCann E, Van Hove I, Lange R, Häufel T, Etropolski M. Health status of patients who received tapentadol prolonged release during an open-label extension study. Osteoarthritis and Cartilage 2010;18:S149.
33. McCann B, Lange R, Wagner B, Steup A, Lange B, Etrolpolski M. Patient Global Impression of Change results from a 1-year open-label extension study of tapentadol extended release in patients with chronic osteoarthritis or low back pain. Arthritis and Rheumatism 2010;62:950.
34. Gálvez R, Schäfer M, Hans G, Falke D, Steigerwald I. Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: results of an open-label, phase 3b study. Advances in Therapy 2013;30(3):229-59.
35. Lange B, Kuperwasser B, Okamoto A, Steup A, Häufel T, Ashworth J, et al. Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain. Advances in Therapy 2010;27(6):381-99.
36. Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clinical Journal of Pain 1993;9(3):174-82.
37. Cochrane Pain, Paliative and Supportive Care Group. PaPaS Author and Referee Guidance (AUREF), 2012. papas.cochrane.org/papas-documents (accessed March 2014).
38. Breivik EK, Björnsson GA, Skovlund E. A comparison of pain rating scales by sampling from clinical trial data. Clinical Journal of Pain 2000;16(1):22-8.
39. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. European Journal of Pain 2006;10(4):287-333.
40. Buskila D, Abramov G, Biton A, Neumann L. The prevalence of pain complaints in a general population in Israel and its implications for utilization of health services. Journal of Rheumatology 2000;27(6):1521-5.
41. Chou R, Fanciullo GJ, Fine PG, Adler JA, Ballantyne JC, Davies P, et al. American Pain Society-American Academy of Pain Medicine Opioids Guidelines Panel. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. Journal of Pain 2009;10(2):113-30.
42. Crombie IK, Croft PR, Linton SJ, LeResche L, Von Korff M (editors). Epidemiology of Pain. Seattle: IASP Press, 1999.
43. Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001;94(2):149-58.
44. Freynhagen R, Baron R, Gockel U, Tölle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Current Medical Research and Opinion 2006;22(10):1911-20.
45. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [update March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
46. International Association for the Study of Pain, Subcommittee on Taxonomy. Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Pain. Supplement 1986;3:S1-226.
47. Jadad AR, Brownman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA 1995;274(23):1870-3.
48. LeResche L. Epidemiologic perspectives on sex differences in pain. In: Fillingim RB editor(s). Sex, Gender, and Pain. Progress in Pain Research and Management. Vol. 17, Seattle: IASP Press, 2000:233-49.
49. Manchikanti L, Ailinani H, Koyyalagunta D, Datta S, Singh V, Eriator I, et al. A systematic review of randomized trials of long-term opioid management for chronic non-cancer pain. Pain Physician 2011;14(2):91-121.
50. Marcus DA. Treatment of nonmalignant chronic pain. American Family Physician 2000;61(5):1331-8.
51. McAlindon TE, Cooper C, Kirwan JR, Dieppe PA. Knee pain and disability in the community. British Journal of Rheumatology 1992;31(3):189-92.
52. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement. PLoS Medicine 2009;6(7):e1000097.
53. Moore RA, Gavaghan DJ, Edwards JE, Wiffen P, McQuay HJ. Pooling data for number needed to treat: no problems for apples. BMC Medical Research Methodology 2002;2:2.
54. Moore RA, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S, et al ACTINPAIN Writing Group of the IASP Special Interest Group on Systematic Reviews in Pain Relief, Cochrane Pain, Palliative and Supportive Care Systematic Review Group Editors. "Evidence" in chronic pain-establishing best practice in the reporting of systematic reviews. Pain 2010;150(3):386-9.
55. Nüesch E, Rutjes A, Husni E, Welch V, Jüni P. Oral or transdermal opioids for osteoarthritis of the knee or hip. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD003115.pub3]
56. Papageogiou AC, Croft P, Ferry S, Jayson MIV, Silman AJ. Estimating the prevalence of low back pain in the general population. Evidence from the South Manchester Back Pain Survey. Spine 1995;20(17):1889-94.
57. Reisine S, Fifield J, Walsh SJ, Feinn R. Factors associated with continued employment among patients with rheumatoid arthritis: a survival model. Journal of Rheumatology 2001;28(11):2400-8.
58. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
59. Riemsma R, Forbes C, Harker J, Misso K, Liedgens H, Schaefer M, et al. A systematic review of tapentadol in chronic moderate to severe pain. Value in Health 2011;14(7):A411.
60. Trescot AM, Helm S, Hansen H, Benyamin R, Glaser SE, Adlaka R, et al. Opioids in the management of chronic non-cancer pain: an update of American Society of the Interventional Pain Physicians' (ASIPP) guidelines. Pain Physician 2008;11(2 Suppl):S5-62.
61. Trescot AM, Datta S, Lee M, Hansen H. Opioid pharmacology. Pain Physician 2008;11(2 Suppl):S133-53.
62. Trescot AM, Glaser SE, Hansen H, Benyamin R, Patel S, Manchikanti L. Effectiveness of opioids in the treatment of chronic non-cancer pain. Pain Physician 2008;11(2 Suppl):S181-200.
63. Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, et al. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Annals of the Rheumatic Diseases 1998;57(11):649-55.
64. World Health Organization. WHO's pain relief ladder 2010. www.who.int/cancer/palliative/painladder/en (accessed 30 April 2012).
65. Wiffen PJ, Derry S, Naessens K, Bell RF. Oral tapentadol for cancer pain. Cochrane Database of Systematic Reviews 2015, Issue 1. [DOI: 10.1002/14651858.CD011460]
66. Santos J, Costa J, Fareleira F, Alarcão J, Vaz-Carneiro A. Tapentadol for chronic musculoskeletal pain in adults. Cochrane Database of Systematic Reviews 2012, Issue 6. [DOI: 10.1002/14651858.CD009923]