Advances in Therapy

, Volume 30, Issue 1, pp 14–27 | Cite as

Tapentadol Extended Release for Chronic Pain Patients

  • Robert Taylor
  • Joseph V. Pergolizzi
  • Robert B. Raffa
Review

Abstract

Introduction

Chronic pain reduces quality of life, utilizes healthcare resources, and increases healthcare costs. It is widespread, but generally inadequately treated or managed, partly due to several obstacles, including a limited number of mechanistic options for long-term pharmacologic agents. Opioids are generally the primary class of analgesic prescribed, but because of associated side effects during long-term treatment, many patients become noncompliant or discontinue treatment. A long-term use analgesic with a good benefit/risk ratio is advantageous.

Methods

A literature search for randomized trials using tapentadol extended release (ER) for noncancer chronic pain patients was conducted. Databases searched included PubMed, MEDLINE, EMBASE, and Google Scholar, using key terms “tapentadol,” “prolonged release,” “extended release,” and “chronic pain” individually or in combination. The results were synthesized and evaluated.

Results

A total of six randomized, controlled studies were identified. Chronic pain conditions analyzed included low back, osteoarthritis, and diabetic peripheral neuropathy. Treatment arms consisted most often of placebo, tapentadol ER (100–250 mg twice daily [b.i.d.]), and/or oxycodone CR (controlled release) (20–50 mg b.i.d.). Subjects treated with tapentadol ER had significant reduction in pain intensity compared to placebo controls and similar efficacy to oxycodone CR. Overall, the safety profile was superior to that of oxycodone CR in regards to reduction in side effects, reduced severity of side effects (particularly gastrointestinal related), and lower study discontinuation rates.

Conclusion

The two mechanisms of analgesic action of tapentadol, combined with an ER, appears to provide equal efficacy to a strong controlled-release opioid while providing greater gastrointestinal tolerability. The reduction in incidence and severity of gastrointestinal side effects correlated with a higher compliance rate. These findings suggest that tapentadol ER might be a viable alternative to conventional strong opioids for pain management for chronic pain patients.

Keywords

Analgesic Chronic pain Pain management Tapentadol extended release 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. 1.
    Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. 2012 ed. Washington, DC: National Academies Press; 2011.Google Scholar
  2. 2.
    Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10:287–333.PubMedCrossRefGoogle Scholar
  3. 3.
    Sjogren P, Ekholm O, Peuckmann V, et al. Epidemiology of chronic pain in Denmark: an update. Eur J Pain. 2009;13:287–292.PubMedCrossRefGoogle Scholar
  4. 4.
    Rustoen T, Wahl AK, Hanestad BR, et al. Prevalence and characteristics of chronic pain in the general Norwegian population. Eur J Pain. 2004;8:555–565.PubMedCrossRefGoogle Scholar
  5. 5.
    Reid KJ, Harker J, Bala MM, et al. Epidemiology of chronic non-cancer pain in Europe: narrative review of prevalence, pain treatments and pain impact. Curr Med Res Opin. 2011;27:449–462.PubMedCrossRefGoogle Scholar
  6. 6.
    David Michaelson & Company. Voices of Chronic Pain: A National Study. American Pain Foundation; 2006. Available at: http://www.davidmichaelsoncompany.com/Documents/Voices%20of%20Chronic%20Pain%20Report.pdf. Accessed Dec 14 2012.
  7. 7.
    Stewart WF, Ricci JA, Chee E, et al. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003;290:2443–2454.PubMedCrossRefGoogle Scholar
  8. 8.
    Stewart WF, Ricci JA, Chee E, et al. Lost productive work time costs from health conditions in the United States: results from the American Productivity Audit. J Occup Environ Med. 2003;45:1234–1246.PubMedCrossRefGoogle Scholar
  9. 9.
    Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain. 2000;84:95–103.PubMedCrossRefGoogle Scholar
  10. 10.
    Gustavsson A, Bjorkman J, Ljungcrantz C, et al. Socio-economic burden of patients with a diagnosis related to chronic pain-register data of 840,000 Swedish patients. Eur J Pain. 2012;16:289–299.PubMedCrossRefGoogle Scholar
  11. 11.
    Bennett MI, Closs SJ. Methodological issues in nonpharmacological trials for chronic pain. Anaesthesia, Pain & Intensive Care. 2010;14:49–55.Google Scholar
  12. 12.
    Tan G, Craine MH, Bair MJ, et al. Efficacy of selected complementary and alternative medicine interventions for chronic pain. J Rehabil Res Dev. 2007;44:195–222.PubMedCrossRefGoogle Scholar
  13. 13.
    Haake M, Muller HH, Schade-Brittinger C, et al. German Acupuncture Trials (GERAC) for chronic low back pain: randomized, multicenter, blinded, parallel-group trial with 3 groups. Arch Intern Med. 2007;167:1892–1898.PubMedCrossRefGoogle Scholar
  14. 14.
    Witt CM, Ludtke R, Wegscheider K, et al. Physician characteristics and variation in treatment outcomes: are better qualified and experienced physicians more successful in treating patients with chronic pain with acupuncture? J Pain. 2010;11:431–435.PubMedCrossRefGoogle Scholar
  15. 15.
    Furlan AD, van Tulder M, Cherkin D, et al. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005;30:944–963.CrossRefGoogle Scholar
  16. 16.
    Manheimer E, White A, Berman B, et al. Metaanalysis: acupuncture for low back pain. Ann Intern Med. 2005;142:651–663.PubMedGoogle Scholar
  17. 17.
    Hoffman BM, Papas RK, Chatkoff DK, et al. Metaanalysis of psychological interventions for chronic low back pain. Health Psychol. 2007;26:1–9.PubMedCrossRefGoogle Scholar
  18. 18.
    Morley S, Eccleston C, Williams A. Systematic review and meta-analysis of randomized controlled trials of cognitive behaviour therapy and behaviour therapy for chronic pain in adults, excluding headache. Pain. 1999;80:1–13.PubMedCrossRefGoogle Scholar
  19. 19.
    Henschke N, Ostelo RW, van Tulder MW, Vlaeyen JW, Morley S, Assendelft WJ, et al. Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev. 2010;(7):CD002014.Google Scholar
  20. 20.
    Dixon KE, Keefe FJ, Scipio CD, et al. Psychological interventions for arthritis pain management in adults: a meta-analysis. Health Psychol. 2007;26:241–250.PubMedCrossRefGoogle Scholar
  21. 21.
    Montgomery GH, DuHamel KN, Redd WH. A meta-analysis of hypnotically induced analgesia: how effective is hypnosis? Int J Clin Exp Hypn. 2000;48:138–153.PubMedCrossRefGoogle Scholar
  22. 22.
    Roelofs PD, Deyo RA, Koes BW, et al. Nonsteroidal anti-inflammatory drugs for low back pain: an updated Cochrane review. Spine (Phila Pa 1976). 2008;33:1766–1774.CrossRefGoogle Scholar
  23. 23.
    Davies RA, Maher CG, Hancock MJ. A systematic review of paracetamol for non-specific low back pain. Eur Spine J. 2008;17:1423–1430.PubMedCrossRefGoogle Scholar
  24. 24.
    Walter RB, Brasky TM, White E. Cancer risk associated with long-term use of acetaminophen in the prospective VITamins and lifestyle (VITAL) study. Cancer Epidemiol Biomarkers Prev. 2011;20:2637–2641.PubMedCrossRefGoogle Scholar
  25. 25.
    Walter RB, Milano F, Brasky TM, et al. Longterm use of acetaminophen, aspirin, and other nonsteroidal anti-inflammatory drugs and risk of hematologic malignancies: results from the prospective Vitamins and Lifestyle (VITAL) study. J Clin Oncol. 2011;29:2424–2431.PubMedCrossRefGoogle Scholar
  26. 26.
    Kuijpers T, van Middelkoop M, Rubinstein SM, et al. A systematic review on the effectiveness of pharmacological interventions for chronic nonspecific low-back pain. Eur Spine J. 2011;20:40–50.PubMedCrossRefGoogle Scholar
  27. 27.
    Chapman CR, Lipschitz DL, Angst MS, et al. Opioid pharmacotherapy for chronic non-cancer pain in the United States: A research guideline for developing an evidence-base. J Pain. 2010;11:807–829.PubMedCrossRefGoogle Scholar
  28. 28.
    Furlan AD, Sandoval JA, Mailis-Gagnon A, Tunks E. Opioids for chronic noncancer pain: a metaanalysis of effectiveness and side effects. CMAJ. 2006;174:1589–1594.PubMedGoogle Scholar
  29. 29.
    Trescot AM, Helm S, Hansen H, 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(Suppl. 5):S5–S62.PubMedGoogle Scholar
  30. 30.
    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–S14.PubMedCrossRefGoogle Scholar
  31. 31.
    Attal N, Cruccu G, Baron R, et al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010;17:1113–e1188.PubMedCrossRefGoogle Scholar
  32. 32.
    Carville SF, Arendt-Nielsen S, Bliddal H, et al. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008;67:536–541.PubMedCrossRefGoogle Scholar
  33. 33.
    Kahan M, Mailis-Gagnon A, Wilson L, et al. Canadian guideline for safe and effective use of opioids for chronic noncancer pain: clinical summary for family physicians. Part 1: general population. Can Fam Physician. 2011;57:1257–1266, e407–18.PubMedGoogle Scholar
  34. 34.
    Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2-guidance. Pain Physician. 2012;15(Suppl. 3):S67–S116.PubMedGoogle Scholar
  35. 35.
    Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140:441–451.PubMedGoogle Scholar
  36. 36.
    Vanderah TW. Pathophysiology of pain. Med Clin North Am. 2007;91:1–12.PubMedCrossRefGoogle Scholar
  37. 37.
    Benarroch EE. Descending monoaminergic pain modulation: bidirectional control and clinical relevance. Neurology. 2008;71:217–221.PubMedCrossRefGoogle Scholar
  38. 38.
    Tanabe M, Takasu K, Kasuya N, et al. Role of descending noradrenergic system and spinal alpha2-adrenergic receptors in the effects of gabapentin on thermal and mechanical nociception after partial nerve injury in the mouse. Br J Pharmacol. 2005;144:703–714.PubMedCrossRefGoogle Scholar
  39. 39.
    Delgado PL. Common pathways of depression and pain. J Clin Psychiatry. 2004;65(Suppl. 12):16–19.PubMedGoogle Scholar
  40. 40.
    Tzschentke TM, Jahnel U, Kogel B, et al. Tapentadol hydrochloride: a next-generation, centrally acting analgesic with two mechanisms of action in a single molecule. Drugs Today (Barc). 2009;45:483–496.Google Scholar
  41. 41.
    Tzschentke TM, Christoph T, Kogel B, et al. (−)-(1R,2R)-3-(3-dimethylamino-1-ethyl-2-methylpropyl)-phenol hydrochloride (tapentadol HCl): a novel mu-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther. 2007;323:265–276.PubMedCrossRefGoogle Scholar
  42. 42.
    Pergolizzi J, Alegre C, Blake D, et al. Current considerations for the treatment of severe chronic pain: the potential for tapentadol. Pain Pract. 2012;12:290–306.PubMedCrossRefGoogle Scholar
  43. 43.
    Raffa RB, Buschmann H, Christoph T, et al. Mechanistic and functional differentiation of tapentadol and tramadol. Expert Opin Pharmacother. 2012;10:1437–1449.CrossRefGoogle Scholar
  44. 44.
    NUCYNTAER (tapentadol extended release tablets) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals; 2012. Available at: www.nucynta.com. Accessed Dec 14 2012.
  45. 45.
    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 activecontrolled phase III study. Clin Drug Investig. 2010;30:489–505.PubMedCrossRefGoogle Scholar
  46. 46.
    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;11:1787–1804.PubMedCrossRefGoogle Scholar
  47. 47.
    Wild JE, Grond S, Kuperwasser B, et al. Longterm safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010;10:416–427.PubMedCrossRefGoogle Scholar
  48. 48.
    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;28:911–936.PubMedCrossRefGoogle Scholar
  49. 49.
    Steigerwald I, Muller M, Kujawa J, et al. Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release ondemand for the management of severe, chronic osteoarthritis-related knee pain: results of an openlabel, phase 3b study. J Pain Res. 2012;5:121–138.PubMedCrossRefGoogle Scholar
  50. 50.
    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;27:151–162.PubMedCrossRefGoogle Scholar
  51. 51.
    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;27:381–399.PubMedCrossRefGoogle Scholar
  52. 52.
    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;1:151–162.CrossRefGoogle Scholar
  53. 53.
    Riemsma R, Forbes C, Harker J, et al. Systematic review of tapentadol in chronic severe pain. Curr Med Res Opin. 2011;27:1907–1930.PubMedCrossRefGoogle Scholar
  54. 54.
    NUCYNTAER (tapentadol extended release tablets) [Risk Evaluation and Mitigation Strategy]. Titusville, NJ: Janssen Pharmaceuticals; 2011.Google Scholar
  55. 55.
    Food and Drug Administration. FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. Available at www.fda.gov. Accessed 14 Dec 2012.

Copyright information

© Springer Healthcare 2013

Authors and Affiliations

  • Robert Taylor
    • 1
  • Joseph V. Pergolizzi
    • 2
    • 3
    • 4
  • Robert B. Raffa
    • 5
  1. 1.NEMA Research, Inc.NaplesUSA
  2. 2.Department of MedicineJohns Hopkins UniversityBaltimoreUSA
  3. 3.Department of PharmacologyTemple University School of MedicinePhiladelphiaUSA
  4. 4.Georgetown University School of MedicineWashington, District of ColumbiaUSA
  5. 5.Department of Pharmaceutical SciencesTemple University School of PharmacyPhiladelphiaUSA

Personalised recommendations