Effectiveness and tolerability of tapentadol sustained release in the Australian setting

Authors

  • Marc A. Russo, MBBS, DA(UK), FANZCA, FFPMANZCA
  • Danielle M. Santarelli, PhD

DOI:

https://doi.org/10.5055/jom.2016.0331

Keywords:

tapentadol, opioid, postmarket, neuropathic pain, nociceptive pain

Abstract

Objective: To assess the effectiveness and tolerability of tapentadol sustained release (SR) following its introduction to the Australian private market.

Design: A retrospective audit of routine clinical practice with data collection beginning 2 months after the first tapentadol SR prescription.

Setting: A multidisciplinary Australian pain clinic.

Patients: Fifty patients who were prescribed tapentadol SR as part of routine clinical management at the pain clinic.

Interventions: Trial of tapentadol SR with subsequent dose titration if the patient was satisfied with or tolerant of the medication.

Main outcome measures: Patient-reported pain outcome, side effects, medication adherence, and concomitant analgesic medications.

Results: Sixty-eight percent of patients reported major reductions in pain. Seventy-two percent of patients tolerated and adhered to treatment and 76 percent reported no side effects. Pain outcome was independent of pain type and prior opioid exposure; however, patients taking tapentadol in combination were more likely to report a positive outcome (Pearson χ2 = 9.867, n = 46, p = 0.0072).

Conclusions: Tapentadol was effective and generally well tolerated in the majority of patients for neuropathic, nociceptive and mixed pain types and this was regardless of prior opioid use.

Author Biographies

Marc A. Russo, MBBS, DA(UK), FANZCA, FFPMANZCA

Hunter Pain Clinic, Broadmeadow, New South Wales, Australia

Danielle M. Santarelli, PhD

Hunter Pain Clinic, Broadmeadow, New South Wales, Australia

References

Askitopoulou H, Ramoutsaki IA, Konsolaki E: Archaeological evidence on the use of opium in the Minoan world. Int Congr Ser. 2002; 1242(0): 23-29.

Wachtel-Galor S, Benzie IFF: Herbal medicine: An introduction to its history, usage, regulation, current trends, and research needs. In Benzie IFF, Wachtel-Galor S (eds.): Herbal Medicine: Biomolecular and Clinical Aspects. 2nd ed. Boca Raton, FL: CRC Press, 2011.

Power I: An update on analgesics. Br J Anaesth. 2011; 107(1): 19-24.

Nelson EM, Philbrick AM: Avoiding serotonin syndrome: The nature of the interaction between tramadol and selective serotonin reuptake inhibitors. Ann Pharmacother. 2012; 46(12): 1712- 1716.

Park SH, Wackernah RC, Stimmel GL: Serotonin syndrome: Is it a reason to avoid the use of tramadol with antidepressants? J Pharm Pract. 2014; 27(1): 71-78.

Reeves RR, Burke RS: Tramadol: Basic pharmacology and emerging concepts. Drugs Today. 2008; 44(11): 827-836.

Takeshita J, Litzinger MH: Serotonin syndrome associated with tramadol. Prim Care Companion J Clin Psychiatry. 2009; 11(5): 273.

Raffa RB, Buschmann H, Christoph T, et al.: Mechanistic and functional differentiation of tapentadol and tramadol. Expert Opin Pharmacother. 2012; 13(10): 1437-1449.

Singh DR, Nag K, Shetti AN, et al.: Tapentadol hydrochloride: A novel analgesic. Saudi J Anaesth. 2013; 7(3): 322-326.

Hartrick CT, Rodriguez Hernandez JR: Tapentadol for pain: A treatment evaluation. Expert Opin Pharmacother. 2012; 13(2): 283-286.

Christoph T, Schroder W, Tallarida RJ, et al.: Spinalsupraspinal and intrinsic mu-opioid receptor agonist-norepinephrine reuptake inhibitor (MOR-NRI) synergy of tapentadol in diabetic heat hyperalgesia in mice. J Pharmacol Exp Ther. 2013; 347(3): 794-801.

Meske DS, Xie JY, Oyarzo J, et al.: Opioid and noradrenergic contributions of tapentadol in experimental neuropathic pain. Neurosci Lett. 2014; 562: 91-96.

Torres-Sanchez S, Alba-Delgado C, Llorca-Torralba M, et al.: Effect of tapentadol on neurons in the locus coeruleus. Neuropharmacology. 2013; 72: 250-258.

Michot B, Bourgoin S, Kayser V, et al.: Effects of tapentadol on mechanical hypersensitivity in rats with ligatures of the infraorbital nerve versus the sciatic nerve. Eur J Pain. 2013; 17(6): 867-880.

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.

Kwong WJ, Hammond G, Upmalis D, et al.: Bowel function after tapentadol and oxycodone immediate release (IR) treatment in patients with low back or osteoarthritis pain. Clin J Pain. 2013; 29(8): 664-672.

Baron R, Likar R, Martin-Mola E, et al.: Effectiveness of tapentadol prolonged release (PR) compared with oxycodone/naloxone PR for the management of severe chronic low back pain with a neuropathic component: A randomized, controlled, open-label, phase 3b/4 study. Pain Pract. 2015 (in press).

Tzschentke TM, Christoph T, Kogel B, et al.: (−)-(1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCl): A novel mu-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther. 2007; 323(1): 265-276.

Cepeda MS, Fife D, Ma Q, et al.: Comparison of the risks of opioid abuse or dependence between tapentadol and oxycodone: Results from a cohort study. J Pain. 2013; 14(10): 1227-1241.

Dart RC, Bartelson BB, Adams EH: Non-medical use of tapentadol immediate release by college students. Clin J Pain. 2014; 30(8): 685-692.

Galvez R, Schafer M, Hans G, et al.: Tapentadol prolonged release versus strong opioids for severe, chronic low back pain: Results of an open-label, phase 3b study. Adv Ther. 2013; 30(3): 229-259.

Schwittay A, Schumann C, Litzenburger BC, et al.: Tapentadol prolonged release for severe chronic pain: Results of a noninterventional study involving general practitioners and internists. J Pain Palliat Care Pharmacother. 2013; 27(3): 225-234.

Steigerwald I, Schenk M, Lahne U, et al.: Effectiveness and tolerability of tapentadol prolonged release compared with prior opioid therapy for the management of severe, chronic osteoarthritis pain. Clin Drug Investig. 2013; 33(9): 607-619.

Imanaka K, Tominaga Y, Etropolski M, et al.: Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain. Curr Med Res Opin. 2013; 29(10): 1399-1409.

Baron R, Kern U, Muller M, et al.: Effectiveness and tolerability of a moderate dose of tapentadol prolonged release for managing severe, chronic low back pain with a neuropathic component: An open-label continuation arm of a randomized phase 3b study. Pain Pract. 2015; 15(5): 471-486.

Vadivelu N, Timchenko A, Huang Y, et al.: Tapentadol extended-release for treatment of chronic pain: A review. J Pain Res. 2011; 4: 211-218.

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): e1113-e1188.

Baron R, Martin-Mola E, Muller M, et al.: Effectiveness and safety of tapentadol prolonged release (PR) versus a combination of tapentadol PR and pregabalin for the management of severe, chronic low back pain with a neuropathic component: A randomized, double-blind, phase 3b study. Pain Pract. 2015; 15(5): 455-470.

Published

05/01/2016

How to Cite

Russo, MBBS, DA(UK), FANZCA, FFPMANZCA, M. A., and D. M. Santarelli, PhD. “Effectiveness and Tolerability of Tapentadol Sustained Release in the Australian Setting”. Journal of Opioid Management, vol. 12, no. 3, May 2016, pp. 187-96, doi:10.5055/jom.2016.0331.

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Section

Articles