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Tapentadol immediate release for moderate to severe acute post-surgery pain

Eugene R. Viscusi, MD, René Allard, PhD, Melanie Sohns, PhD, Mariëlle Eerdekens, MD, MBA

Abstract


Objective: To investigate efficacy and tolerability of tapentadol immediate release (IR) in the treatment of moderate to severe acute pain in three surgical pain models.

Design: Three randomized, double-blind, placebo- and active-controlled, multicenter, phase 3 trials were performed in total hip replacement surgery, abdominal hysterectomy, and bunionectomy with trial medications administered every 4-6 hours as needed for up to 72 hours. Tapentadol IR was included in all trials, oxycodone IR in the total hip replacement trial, and morphine IR in the abdominal hysterectomy and bunionectomy trials; active controls ensured assay sensitivity.

Main outcome measures: The primary efficacy endpoint was the sum of pain intensity differences over the first 24 hours of treatment (SPID24) in the abdominal hysterectomy trial and SPID48 in the other two trials. Tolerability was assessed by adverse events reporting.

Results: A total of 330, 832, and 285 patients with total hip replacement, abdominal hysterectomy, and bunionectomy, respectively, were assessed for efficacy. All three trials demonstrated statistically significant improvements of tapentadol IR on the primary endpoint versus placebo and similar improvements compared to morphine IR or oxycodone IR. These findings were consistent with results of total pain relief assessments and patients’ global impressions of change in their overall health status after 72 hours (abdominal hysterectomy, bunionectomy). The tolerability profile of tapentadol IR was as expected for a centrally acting analgesic in the post-surgery setting.

Conclusions: Tapentadol IR has strong analgesic efficacy and is well tolerated in multiple post-surgery conditions of moderate to severe pain.


Keywords


tapentadol, post-surgery pain, morphine, oxycodone, orthopedic surgery, visceral surgery

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References


van Ransbeeck A, Budilivski A, Spahn DR, et al.: Pain assessment discrepancies: A cross-sectional study highlights the amount of underrated pain. Pain Pract. 2018; 18: 360-367.

Maier C, Nestler N, Richter H, et al.: The quality of pain management in German hospitals. Dtsch Arztebl Int. 2010; 107: 607-614.

Gan TJ, Habib AS, Miller TE, et al.: Incidence, patient satisfaction, and perceptions of post-surgical pain: Results from a US national survey. Curr Med Res Opin. 2014; 30: 149-160.

Gerbershagen HJ, Aduckathil S, van Wijck AJ, et al.: Pain intensity on the first day after surgery: A prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013; 118: 934-944.

Gan TJ: Poorly controlled postoperative pain: Prevalence, consequences, and prevention. J Pain Res. 2017; 10: 2287-2298.

Chou R, Gordon DB, de Leon-Casasola OA, et al.: Management of postoperative pain: A clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016; 17: 131-157.

Tzschentke TM, Christoph T, Kögel BY: The mu-opioid receptor agonist/noradrenaline reuptake inhibition (MOR-NRI) concept in analgesia: The case of tapentadol. CNS Drugs. 2014; 28: 319-329.

Electronic Medicines Compendium: Palexia film coated tablets. Available at https://www.medicines.org.uk/emc/medicine/28375. Accessed December 13, 2018.

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: 1095-1104.

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: 260-271.

Biondi D, Xiang J, Benson C, et al.: Tapentadol immediate release versus oxycodone immediate release for treatment of acute low back pain. Pain Physician. 2013; 16: E237-E246.

Vorsanger GJ, Farrell J, Xiang J, et al.: Tapentadol, oxycodone or placebo for acute pain of vertebral compression fractures: A randomized phase IIIb study. Pain Manage. 2013; 3: 109-118.

Stegmann JU, Weber H, Steup A, et al.: The efficacy and tolerability of multiple-dose tapentadol immediate release for the relief of acute pain following orthopaedic (bunionectomy) surgery. Curr Med Res Opin. 2008; 24: 3185-3196.

Daniels SE, Upmalis D, Okamoto A, et al.: 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: 765-776.

Daniels SE, Casson E, Stegmann JU, et al.: 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. 2009; 25: 1551-1561.

Lee YK, Ko JS, Rhim HY, et al.: Acute postoperative pain relief with immediate-release tapentadol: Randomized, double-blind, placebo-controlled study conducted in South Korea. Curr

Med Res Opin. 2014; 30: 2561-2570.

Chen YJ, Chiang CC, Huang J, et al.: Tapentadol immediate-release for acute postbunionectomy pain: A phase 3, randomized, double-blind, placebo-controlled, parallel-group study in Taiwan. Curr Med Res Opin. 2015; 31: 2001-2009.

Vorsanger GJ, Klopfer AM, Xiang J, et al.: Immediate-release tapentadol or oxycodone for treatment of acute postoperative pain after elective arthroscopic shoulder surgery: A randomized, phase IIIb study. J Opioid Manag. 2013; 9: 281-290.

Singla NK, Desjardins PJ, Chang PD: A comparison of the clinical and experimental characteristics of four acute surgical pain models: Dental extraction, bunionectomy, joint replacement, and soft tissue surgery. Pain. 2014; 155: 441-456.

European Medicines Agency: Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Nociceptive Pain. London: European Medicines Agency, 2002. CPMP/EWP/612/00. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003525.pdf. Accessed December 13, 2018.

Guy W: ECDEU Assessment Manual for Psychopharmacology (DHEW Publication no. ADM 76-338). Washington, DC: US Government Printing Office, 1976.

Pierre S, Whelan R: Nausea and vomiting after surgery. Contin Educ Anaesth Crit Care Pain. 2013; 13: 28-32.

Mason SE, Noel-Storr A, Ritchie CW: The impact of general and regional anesthesia on the incidence of post-operative cognitive dysfunction and post-operative delirium: A systematic review with meta-analysis. J Alzheimers Dis. 2010; 22(suppl 3): 67-79.

Youngblom E, DePalma G, Sands L, et al.: The temporal relationship between early postoperative delirium and postoperative cognitive dysfunction in older patients: A prospective cohort study. Can J Anaesth. 2014; 61: 1084-1092.

García PS, Duggan EW, McCullough IL, et al.: Postanesthesia care for the elderly patient. Clin Ther. 2015; 37: 2651-2665.

Vorsanger G, Xiang J, Biondi D, et al.: Post hoc analyses of data from a 90-day clinical trial evaluating the tolerability and efficacy of tapentadol immediate release and oxycodone immediate release for the relief of moderate to severe pain in elderly and nonelderly patients. Pain Res Manag. 2011; 16: 245-251.

Goldstein DJ, Turk DC: Dextropropoxyphene: Safety and efficacy in older patients. Drugs Aging. 2005; 22: 419-432.

Dahan A, Aarts L, Smith TW: Incidence, reversal, and prevention of opioid-induced respiratory depression. Anesthesiology. 2010; 112: 226-238.

Stollenwerk A, Sohns M, Heisig F, et al.: Review of post-marketing safety data on tapentadol, a centrally acting analgesic. Adv Ther. 2018; 35: 12-30.




DOI: http://dx.doi.org/10.5055/jom.2019.0486

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