Evaluation of analgesic effect of tapentadol, a central novel analgesic versus tramadol, a widely used opioid analgesic in treatment of low back pain: a randomized controlled trial
Keywords:Tapentadol, Low back pain, Tramadol, Pain Relief Rate, Central novel analgesic
Background: The objective of the study was to compare efficacy and tolerability (safety) of tapentadol with tramadol in the treatment of low back pain.
Methods: The study was a prospective, randomized, single blinded, total 102 patients are recruited for study in which 44 patients are prescribed (50mgtwice daily) tapentadol and 58 patients prescribed (50mg twice daily) tramadol for 4 weeks. Follow-up was done on days 7, 14, 28 and 4 week after stoppage of treatment. Assessment of improvement were performed by Indian Health Assessment Questionnaire Disability Index (Indian HAQDI), Visual Analogue Scale (VAS), Numerical Rating Scale (NRS) and measurement of Pain Relief Rate (PRR). Adverse events were recorded.
Results: Scores in Indian HAQDI, VAS and NRS improved significantly in both groups in the last visit but more so with tapentadol. PRR was reasonably higher with tapentadol [27(n=44)61.36%] patients experiencing significant to complete pain relief at the end of the study, compared to tramadol [25(n=58) 43.10%]. Adverse effects was less in tapentadol group [15(n=44)34.09%] versus 33(n=58)56.89%], p<0.05].
Conclusion: Tapentadol has better sustained efficacy and tolerability than tramadol in low back pain.
Dickenson, AH, KIeffer B. Opiates: basic mechanisms. In: Textbook of pain. McMahon SB, Koltzenburg M, eds. Elsevier, 2006: 427-42.
Portenoy RK, Foley KM, Inturrisi CE. Pain 1990;43:273-86.
Suzuki R, Chapman V, Dickenson AH. Pain 1999; 80:215-28.
Howe JR, Wang JY, Yaksh TL. J Pharmacol Exp Ther 1983;224:552-8.
Proudfit HK. Prog Brain Res 1988;77:357-70.
Yaksh TL. Pharmacol Biochem Behav1985;22:845-58.
Nicholas AP, Pieribone V, Hokfelt T. J Comp Neurol 1993;328:575-94.
Shi TJ, Winzer-Serhan U, Leslie F, et al. Neuroreport 1999;10:2835-9.
Ren K, Ruda MA. Neuroreport 1996;7:2186-90.
Suzuki R, Morcuende S, Webber M, et al. Nat Neurosci 2002;5:1319-26.
Rahman W, D’Mello R, Dickenson AH. J Pain 2008;9:350-9.
Budai D, Harasawa I, Fields HL. J Neurophysiol 1998;80:2244-54.
Sullivan AF, Kalso EA, McQuay HJ, et al. Eur J Pharmacol 1992;215:127-33.
Christoph T, De Vry J, Tzschentke TM. Neurosci Lett 2010;470:91-4.
Jeong ID, Camilleri M, Shin A, Iturrino J, Boldingh A, Busciglio I, et al. A randomised, placebo-controlled trial comparing the effects of tapentadol and oxycodone on gastrointestinal and colonic transit in healthy humans. Aliment Pharmacol
Ther 2012. doi: 10.1111/j.1365-2036.2012.05040.x.
Vadivelu N, Timchenko A, Huang Y, Sinatra R (2011). Tapentadol extended-release for treatment of chronic pain: a review. J Pain Res 4:211-8.
Wade WE, Spruill WJ (2009). Tapentadol hydrochloride: a centrally acting oral analgesic. Clin Ther 2009;31(12):2804-18.
Daniels SE, Upmalis D, Okamoto A, Lange C, Haeussler J. A randomized, double-blind, phase III study comparing multiple doses of tapentadol IR, oxycodone IR, and placebo for postoperative (bunionectomy) pain. Curr Med Res Opin 2009;25(3):765-76.
Stegmann JU, Weber H, Steup A, Okamoto A, Upmalis D, Daniels S (2008). The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopedic (bunionectomy) surgery. Curr Med Res Opin 24(11): 3185-3196.
Etropolski M, Kelly K, Okamoto A, Rauschkolb C (2011). Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride. Adv Ther 28(5): 401-417.
Afilalo M, Etropolski MS, Kuperwasser B, Kelly K, Okamoto A, Van Hove I, et al. (2010). 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 randomised double-blind, placebo- and active-controlled phase III study. Clin Drug Investig 30(8): 489-505.
Etropolski MS, Okamoto A, Shapiro DY, Rauschkolb C (2010). Dose conversion between tapentadol immediate and extended release for low back pain. Pain Physician 13(1): 61-70.
Lange B, Kuperwasser B, Okamoto A, Steup A, Haufel T, Ashworth J, et al. (2010). Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain. Adv Ther 27(6): 381-399.
Schwartz S, Etropolski M, Shapiro DY, Okamoto A, Lange R, Haeussler J, et al. (2011). 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 27(1): 151-162.
Steigerwald I, Muller M, Davies A, Samper D, Sabatowski R, Baron R, et al. (2012). 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.
Hartrick CT, Rodriguez Hernandez JR (2012). Tapentadol for pain: a treatment evaluation. Expert Opin Pharmacother 13(2): 283-286.
Hoy SM (2012). Tapentadol extended release: in adults with chronic pain. Drugs 72(3): 375-393.
Pierce DM, Shipstone E. Pharmacology Update: Tapentadol for Neuropathic Pain. Am J Hosp Palliat Care 2012;29:663-6.
Daniels S, Casson E, Stegmann JU, Oh C, Okamoto A, Rauschkolb C, et al. (2009a). A randomized, double-blind, placebo-controlled phase 3 study of the relative efficacy and tolerability of tapentadol IR and oxycodone IR for acute pain. Curr Med Res Opin 25(6): 1551-1561.
Hale M, Upmalis D, Okamoto A, Lange C, Rauschkolb C (2009). 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 25(5): 1095-1104.
Hartrick C, Van Hove I, Stegmann JU, Oh C, Upmalis D. 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(2): 260-271.
Vorsanger G, Xiang J, Okamoto A, Upmalis D, Moskovitz B. Evaluation of study discontinuations with tapentadol immediate release and oxycodone immediate release in patients with low back or osteoarthritis pain. J Opioid Manag 2010;6(3):169-79.