Systematic review of tapentadol in chronic severe pain

Current Medical Research and Opinion

Volumn 27, Issue 10, 2011, Pages 1907-1930

  Riemsma, Rob ^a   Forbes, Carol ^a   Harker, Julie ^a   Worthy, Gill ^a   Misso, Kate ^a   Schäfer, Michael ^b   Kleijnen, Jos ^a,c   Stürzebecher, Steffen ^d  

^a KLEIJNEN SYSTEMATIC REVIEWS LTD   (United Kingdom)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c MAASTRICHT UNIVERSITY   (Netherlands)

^d Independent Consultant ^*  (Germany)

Author keywords

Chronic pain; Opioids; Systematic review; Tapentadol

Indexed keywords

BUPRENORPHINE; FENTANYL; HYDROMORPHONE; METHADONE; MORPHINE; MORPHINE SULFATE; NALTREXONE; NAPROXEN; OXYCODONE; OXYMORPHONE; PALEXIA; TAPENTADOL; UNCLASSIFIED DRUG;

ANALGESIA; CANCER PAIN; CHRONIC PAIN; CONSTIPATION; DIZZINESS; DRUG WITHDRAWAL; HUMAN; NAUSEA; NEUROPATHIC PAIN; PAIN ASSESSMENT; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SLEEP QUALITY; SOMNOLENCE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; VOMITING;

CHRONIC PAIN; CLINICAL TRIALS AS TOPIC; DATABASES, FACTUAL; EUROPE; HUMANS; PAIN MEASUREMENT; PHENOLS; QUALITY OF LIFE;

EID: 80053017293     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2011.611494     Document Type: Review

References (59)

1. Fricker J. Pain in Europe survey. Cambridge: Mundipharma International Limited, 2004 http://www.britishpainsociety.org/Pain%20in%20Europ%20 survey%20report.pdf [Last accessed 17 August 2009]
2. Allan L, Richarz U, Simpson K, et al. Transdermal fentanyl versus sustained release oral morphine in strong-opioid naive patients with chronic low back pain. Spine 2005;30:2484-90 (Pubitemid 41669082)
3. Gimbel JS, Richards P, Portenoy RK. Controlled-release oxycodone for pain in diabetic neuropathy: a randomized controlled trial. Neurology 2003;60:927-34 (Pubitemid 36348923)
4. Harke H. The risk of chronification of invasive pain therapy. Journal fur Anasthesie und Intensivbehandlung 2001;8:46-8 (Pubitemid 32436640)
5. Mucci-LoRusso P, Berman BS, Silberstein PT, et al. Controlled-release oxycodone compared with controlled-release morphine in the treatment of cancer pain: a randomized, double-blind, parallel-group study. Eur J Pain 1998;2:239-49 (Pubitemid 28474354)
6. van Seventer R, Smit JM, Schipper RM, et al. Comparison of TTS-fentanyl with sustained-release oral morphine in the treatment of patients not using opioids for mild-to-moderate pain. Curr Med Res Opin 2003;19:457-69 (Pubitemid 37122037)
7. Eisenberg E, McNicol ED, Carr DB. Opioids for neuropathic pain. Cochrane Database Syst Rev 2006, Issue 3. Art. No.: CD006146. DOI: 10.1002/14651858. CD006146
8. Cepeda MS, Camargo F, Zea C, et al. Tramadol for osteoarthritis. Cochrane Database Syst Rev 2006, Issue 3. Art. No.: CD005522. DOI: 10.1002/14651858. CD005522.pub2
9. Deshpande A, Furlan A, Mailis-Gagnon A, et al. Opioids for chronic low-back pain. Cochrane Database Syst Rev 2007, Issue 3. Art. No.: CD004959. DOI: 10.1002/14651858.CD004959.pub3, 2007
10. 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;27:381-99
11. Higgins JPT, Green S. Cochrane Handbook of Systematic Reviews of Interventions. Version 5.0.2. [updated September 2009]. The Cochrane Collaboration, 2009
12. Puhan MA, Bachmann LM, Kleijnen J, et al. Inhaled drugs to reduce exacerbations in patients with chronic obstructive pulmonary disease: a network meta-analysis. BMC Med 2009;7:2
13. Bekkering T, Dahan A, Kessels F, et al. Systematic review comparing morphine to placebo and other step III oral and transdermal opioids for the relief of non-cancer and cancer-related chronic pain. York: Kleijnen Systematic Reviews Ltd, 2009
14. Hale M, Upmalis D, Okamoto A, et al. Tolerability of tapentadol immediate release in patients with lower back pain or osteoarthritis of the hip or knee over 90 days: a randomized, double-blind study. Curr Med Res Opin 2009; 25:1095-104
15. Hartrick C, Van Hove I, Stegmann JU, et al. Efficacy and tolerability of tapentadol immediate release and oxycodone HCl immediate release in patients awaiting primary joint replacement surgery for end-stage joint disease: a 10-day, phase III, randomized, double-blind, active-and placebo-controlled study. Clin Ther 2009;31:260-71
16. 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;30:489-505
17. 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;11:1787-804
18. 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;10:416-27
19. http://download.veritasmedicine.com/PDF/CR004183-CSR.pdf [Last accessed 17 August 2011]
20. Biewenga J, Cohen N, Etropolski M, et al. A Randomized Double-Blind, Placebo-and Active-Control, Parallel-Arm, Phase 3 Study with Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of Tapentadol Extended-Release (ER) in Subjects with Moderate to Severe Chronic Low Back Pain Protocol (R331333-PAI-3011 (KF5503/23)). Raritan, NJ: Grü nenthal GmbH, in codevelopment with Johnson & Johnson Pharmaceutical Research &Development LLC, 2009:1-3916
21. Kelly K, Lange B, McNeill M, et al. A Randomized Double-Blind, Placebo-and Active-Control, Parallel-Arm, Phase 3 Study with Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of Tapentadol Extended-Release (ER) in Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee (R331333-PAI-3008 (KF5503/11)). Raritan, NJ: Grü nenthal GmbH, in codevelopment with Johnson & Johnson Pharmaceutical Research & Development LLC, 2009:1-5321
22. Kuperwasser B, McCann B, Gilbert J, et al. A One-Year, Randomized, Open-Label, Parallel-Arm, Phase 3 Long-Term Safety Study, with Controlled Adjustment of Dose, of Multiple Doses of Tapentadol Extended-Release (ER) and Oxycodone Controlled-Release (CR) in Subjects with Chronic Pain (R331333-PAI-3007 (KF5503/24)). Raritan, NJ: Grünenthal GmbH, Johnson & Johnson Pharmaceutical Research & Development LLC, 2009:1-13129
23. Sittl R, Griessinger N, Likar R. Analgesic efficacy and tolerability of transdermal buprenorphine in patients with inadequately controlled chronic pain related to cancer and other disorders: a multicenter, randomized, doubleblind, placebo-controlled trial. Clin Ther 2003;25:150-68 (Pubitemid 36206743)
24. Munera C, Drehobl M, Sessler NE, et al. A randomized, placebo-controlled, double-blinded, parallel-group, 5-week study of buprenorphine transdermal system in adults with osteoarthritis. J Opioid Manag 2010;6:193-202
25. Harke H, Gretenkort P, Ladleif HU, et al. The response of neuropathic pain and pain in complex regional pain syndrome I to carbamazepine and sustained-release morphine in patients pretreated with spinal cord stimulation: a double-blinded randomized study. Anesth Analg 2001;92: 488-95 (Pubitemid 32127642)
26. Ventafridda V, Ripamonti C, Bianchi M, et al. A randomized study on oral administration of morphine and methadone in the treatment of cancer pain. J Pain Symptom Manage 1986;1:203-7 (Pubitemid 17215919)
27. Bruera E, Palmer JL, Bosnjak S, et al. Methadone versus morphine as a firstline strong opioid for cancer pain: a randomized, double-blind study. J Clin Oncol 2004;22:185-92 (Pubitemid 41095131)
28. Ahmedzai S, Brooks D. Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life. The TTSFentanyl Comparative Trial Group [see comment]. J Pain Symptom Manage 1997;13:254-61 (Pubitemid 27240678)
29. Alza Corporation DU. A Study to Evaluate the Effectiveness and Safety of Slow Release Hydromorphone HCL for Treatment of Patients With Osteoarthritis. Nct00411164 2006
30. Binsfeld H, Szczepanski L, Waechter S. A randomized study to demonstrate non-inferiority of once-daily OROS hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic non-malignant pain. Pain Pract 2010;10:404-15
31. Breivik H, Ljosaa TM, Stengaard-Pedersen K, et al. A 6-months, randomised, placebo-controlled evaluation of efficacy and tolerability of a low-dose 7-day buprenorphine transdermal patch in osteoarthritis patients naive to potent opioids. Scand J Pain 2010;1:122-41
32. Caldwell J, Rapoport R, Davis J, 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;23:278-91 (Pubitemid 34462941)
33. Chindalore VL, Craven RA, Yu KP, et al. Adding ultralow-dose naltrexone to oxycodone enhances and prolongs analgesia: a randomized, controlled trial of Oxytrex. J Pain 2005;6:392-9 (Pubitemid 40804344)
34. Hanna M, Thipphawong J. 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
35. Heiskanen T, Kalso E. Controlled-release oxycodone and morphine in cancer related pain. Pain 1997;73:37-45 (Pubitemid 27470824)
36. Heiskanen TE, Ruismaki PM, Seppala TA, et al. Morphine or oxycodone in cancer pain? Acta Oncol 2000;39:941-7 (Pubitemid 32094774)
37. Jamison RN, Raymond SA, Slawsby EA, et al. Opioid therapy for chronic noncancer back pain. A randomized prospective study. Spine 1998;23: 2591-600 (Pubitemid 29003533)
38. Etropolski M, Huiling P, Smit H, et al. A 4-Week Randomized, Multicenter, Double-Blind, Placebo-and Active-Controlled, Parallel-Group, Forced-Titration Phase 2b Study Comparing Efficacy and Safety of Ascending Doses of CG5503 Prolonged Release (PR) up to 233 mg b.i.d. and Oxycodone CR 20 mg Prolonged Release up to 20 mg b.i.d. to Placebo in Subjects with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee (KF5503/19 (R331333-PAI-2001)). Raritan, NJ: Grünenthal GmbH, in codevelopment with Johnson & Johnson Pharmaceutical Research & Development LLC, 2007:1-2682
39. Afilalo M, Upmalis D, Oh C, et al. A Randomized, Double-Blind, Active-and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Multiple Doses of CG5503 Immediate-Release Formulation in Subjects Awaiting Primary Joint Replacement Surgery for End-Stage Joint Disease (R331333-PAI-3002 (KF5503/33)). Raritan, NJ: Grünenthal GmbH, in codevelopment with Johnson & Johnson Pharmaceutical Research & Development LLC, 2007:1-8896
40. Masukawa L, Sechler J, Antle P, et al. A Randomized, Double-Blind, Active-Control, Parallel-Group, 90-Day Safety Study of CG5503 (Tapentadol HCl) Immediate Release or Oxycodone Immediate Release in Subjects with Chronic Pain from Low Back Pain or Osteoarthritis of the Hip or Knee (R331333-PAI-3004 (J&JPRD); KF5503/34). Raritan, NJ: Grünenthal GmbH, in codevelopment with Johnson & Johnson Pharmaceutical Research & Development LLC, 2007:1-8227
41. Kivitz A, Ma C, Ahdieh H, et al. A 2-week, multicenter, randomized, doubleblind, placebo-controlled, dose-ranging, phase III trial comparing the efficacy of oxymorphone extended release and placebo in adults with pain associated with osteoarthritis of the hip or knee. Clin Ther 2006;28:352-64 (Pubitemid 43783436)
42. Kress HG, Von der Laage D, Hoerauf KH, et al. A randomized, open, parallel group, multicenter trial to investigate analgesic efficacy and safety of a new transdermal fentanyl patch compared to standard opioid treatment in cancer pain. J Pain Symptom Manage 2008;36:268-79
43. Langford R, McKenna F, Ratcliffe S, et al. Transdermal fentanyl for improvement of pain and functioning in osteoarthritis: a randomized, placebocontrolled trial. Arthritis Rheum 2006;54:1829-37 (Pubitemid 43877932)
44. Langford R. Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Investigate the Analgesic Effect of OROS Hydromorphone Hydrochloride in Comparison with Placebo in Subjects with Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee. Janssen-Cilag Clinical Synopsis, 2009
45. Markenson JA, Croft J, Zhang PG, et al. Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial. Clin J Pain 2005;21:524-35 (Pubitemid 41527742)
46. Matsumoto AK, Babul N, Ahdieh H. Oxymorphone extended-release tablets relieve moderate to severe pain and improve physical function in osteoarthritis: results of a randomized, double-blind, placebo-and active-controlled phase III trial. Pain Med 2005;6:357-66 (Pubitemid 41727333)
47. Mercadante S, Casuccio A, Agnello A, et al. Morphine versus methadone in the pain treatment of advanced-cancer patients followed up at home. J Clin Oncol 1998;16:3656-61 (Pubitemid 28506781)
48. Mercadante S, Porzio G, Ferrera P, et al. Sustained-release oral morphine versus transdermal fentanyl and oral methadone in cancer pain management. Eur J Pain 2008;12:1040-6
49. Mercadante S, Tirelli W, David F, et al. Morphine versus oxycodone in pancreatic cancer pain: a randomized controlled study. Clin J Pain 2010; 26:794-7
50. Nicholson B, Ross E, Sasaki J, et al. Randomized trial comparing polymercoated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain. Curr Med Res Opin 2006;22: 1503-14 (Pubitemid 44297429)
51. Öztürk T, Karadibak K, Catal D, et al. [Comparison of TD-fentanyl with sustained-release morphine in the pain treatment of patients with lung cancer]. Agri 2008;20:20-5
52. Pace MC, Passavanti MB, Grella E, et al. Buprenorphine in long-term control of chronic pain in cancer patients. Front Biosci 2007;12:1291-9 (Pubitemid 46846834)
53. Rauck RL, Bookbinder S, Bunker T, et al. Oral once-a-day AVINZA (morphine sulfate extended release capsules) vs. twice daily OxyContin (oxycodone hydrochloride controlled release): a randomized, multi-centre study for the treatment of chronic moderate to severe low back pain. J Pain 2006;7:S54
54. Richards P, Zhang P, Friedman M, et al. Controlled-release oxycodone relieves moderate to severe pain in a 3-month study of persistent moderate to severe back pain. Pain Med 2002;3:176
55. Roth SH, Fleischmann RM, Burch FX, et al. Around-the-clock, controlledrelease oxycodone therapy for osteoarthritis-related pain: placebo-controlled trial and long-term evaluation. Arch Intern Med 2000;160:853-60 (Pubitemid 30165247)
56. van Seventer R, Smit JM, Schipper RM, et al. Comparison of TTS-fentanyl with sustained-release oral morphine in the treatment of patients not using opioids for mild-to-moderate pain. Curr Med Res Opin 2003;19:457-69 (Pubitemid 37122037)
57. Webster LR, Butera PG, Moran LV, et al. Oxytrex minimizes physical dependence while providing effective analgesia: a randomized controlled trial in low back pain. J Pain 2006;7:937-46 (Pubitemid 44854737)
58. Zautra AJ, Smith BW. Impact of controlled-release oxycodone on efficacy beliefs and coping efforts among osteoarthritis patients with moderate to severe pain. Clin J Pain 2005;21:471-7 (Pubitemid 41527735)
59. Rauck RL, Bookbinder SA, Bunker TR, et al. The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain. J Opioid Manag 2006;2:155-66