Tapentadol Extended Release for Chronic Pain Patients
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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.
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.
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.
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.
- 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.
- 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. CrossRef
- Sjogren P, Ekholm O, Peuckmann V, et al. Epidemiology of chronic pain in Denmark: an update. Eur J Pain. 2009;13:287–292. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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.
- 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. CrossRef
- 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. CrossRef
- Maniadakis N, Gray A. The economic burden of back pain in the UK. Pain. 2000;84:95–103. CrossRef
- 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. CrossRef
- Bennett MI, Closs SJ. Methodological issues in nonpharmacological trials for chronic pain. Anaesthesia, Pain & Intensive Care. 2010;14:49–55.
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- Manheimer E, White A, Berman B, et al. Metaanalysis: acupuncture for low back pain. Ann Intern Med. 2005;142:651–663.
- Hoffman BM, Papas RK, Chatkoff DK, et al. Metaanalysis of psychological interventions for chronic low back pain. Health Psychol. 2007;26:1–9. CrossRef
- 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. CrossRef
- 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.
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- Davies RA, Maher CG, Hancock MJ. A systematic review of paracetamol for non-specific low back pain. Eur Spine J. 2008;17:1423–1430. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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.
- 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.
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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.
- 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.
- Woolf CJ. Pain: moving from symptom control toward mechanism-specific pharmacologic management. Ann Intern Med. 2004;140:441–451.
- Vanderah TW. Pathophysiology of pain. Med Clin North Am. 2007;91:1–12. CrossRef
- Benarroch EE. Descending monoaminergic pain modulation: bidirectional control and clinical relevance. Neurology. 2008;71:217–221. CrossRef
- 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. CrossRef
- Delgado PL. Common pathways of depression and pain. J Clin Psychiatry. 2004;65(Suppl. 12):16–19.
- 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.
- 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. CrossRef
- 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. CrossRef
- Raffa RB, Buschmann H, Christoph T, et al. Mechanistic and functional differentiation of tapentadol and tramadol. Expert Opin Pharmacother. 2012;10:1437–1449. CrossRef
- NUCYNTAER (tapentadol extended release tablets) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals; 2012. Available at: www.nucynta.com. Accessed Dec 14 2012.
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- 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. CrossRef
- Riemsma R, Forbes C, Harker J, et al. Systematic review of tapentadol in chronic severe pain. Curr Med Res Opin. 2011;27:1907–1930. CrossRef
- NUCYNTAER (tapentadol extended release tablets) [Risk Evaluation and Mitigation Strategy]. Titusville, NJ: Janssen Pharmaceuticals; 2011.
- 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.
- Tapentadol Extended Release for Chronic Pain Patients
Advances in Therapy
Volume 30, Issue 1 , pp 14-27
- Cover Date
- Print ISSN
- Online ISSN
- Springer Healthcare Communications
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- Chronic pain
- Pain management
- Tapentadol extended release
- Industry Sectors
- Author Affiliations
- 1. NEMA Research, Inc., 840 111th Ave, Naples, Florida, USA
- 2. Department of Medicine, Johns Hopkins University, Baltimore, Maryland, USA
- 3. Department of Pharmacology, Temple University School of Medicine, Philadelphia, Pennsylvania, USA
- 4. Georgetown University School of Medicine, Washington, District of Columbia, USA
- 5. Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, Pennsylvania, USA