Safety of tapentadol compared with other opioids in chronic pain treatment: network meta-analysis of randomized controlled and withdrawal trials

References

• O’Brien T, Christrup L, Drewes A, et al. European Pain Federation position paper on appropriate opioid use in chronic pain management. Eur J Pain. 2017;21(1):3–19.
   PubMed Web of Science ®Google Scholar
• Van Amsterdam J, van den Brink W. The misuse of prescription opioids: a threat for Europe? Curr Drug Abuse Rev. 2015;8(1):3–14.
   PubMedGoogle Scholar
• National Institutes of Health. Pathways to prevention workshop: the role of opioids in the treatment of chronic pain. Rockville (MD): National Institutes of Health; 2014.
   Google Scholar
• Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain-United States, 2016. J Am Med Assoc. 2016;315(15):1624–1645.
   PubMed Web of Science ®Google Scholar
• Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. Oxford (UK): The Cochrane Collaboration; 2011.
   Google Scholar
• Khan KS, Ter Riet G, Glanville J, et al. Undertaking systematic reviews of research on effectiveness: CRD’s guidance for those carrying out or commissioning reviews. 2nd ed. York (UK): Centre for Reviews and Dissemination (CRD); 2001. (CRD Report 4).
   Google Scholar
• Centre for Reviews and Dissemination [Internet]. PROSPERO. York (UK): CRD; 2011. [Cited 2015 June 29]. Available from: http://www.crd.york.ac.uk/PROSPERO/
   Google Scholar
• Higgins JPT, Altman DG, Sterne JAC. Assessing risk of bias in included studies. In: Cochrane handbook for systematic reviews of interventions. Version 510. Oxford (UK): The Cochrane Collaboration; 2011.
   Google Scholar
• Australian Government Department of Health and Aging. Guidelines for preparing submissions to the Pharmaceutical Benefits Advisory Committee. Version 4.3. Canberra (Australia): Pharmaceutical Benefits Advisory Committee (PBAC); 2008.
   Google Scholar
• Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol. 1997;50(6):683–691.
   PubMed Web of Science ®Google Scholar
• Dias S, Welton NJ, Sutton AJ, et al. NICE DSU technical support document 2: a generalised linear modelling framework for pairwise and network meta-analysis of randomized controlled trials. Sheffield (UK): Decision Support Unit, ScHARR, 2011.
   Google Scholar
• Rhodes KM, Turner RM, Higgins JP. Predictive distributions were developed for the extent of heterogeneity in meta-analyses of continuous outcome data. J Clin Epidemiol. 2015;68(1):52–60.
   PubMed Web of Science ®Google Scholar
• Dias S, Welton NJ, Sutton AJ, et al. NICE DSU technical support document 4: Inconsistency in networks of evidence based on randomized controlled trials. Sheffield (UK): Decision Support Unit, ScHARR, 2011.
   Google Scholar
• European Patients’ Academy (EUPATI) [Internte]. Clinical trial designs. Brussels (Belgium): European Patients’ Forum (EPF); 2015 [updated 2015 November 23; cited 2020 January]. Available from: https://www.eupati.eu/clinical-development-and-trials/clinical-trial-designs/#Withdrawal_trials
   Google Scholar
• Binsfeld H, Szczepanski L, Waechter S, et al. A randomized study to demonstrate noninferiority of once-daily OROS(®) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010;10(5):404–415.
   PubMed Web of Science ®Google Scholar
• Imanaka K, Tominaga Y, Etropolski M, et al. Ready conversion of patients with well-controlled, moderate to severe, chronic malignant tumor-related pain on other opioids to tapentadol extended release. Clin Drug Investig. 2014;34(7):501–511.
   PubMed Web of Science ®Google Scholar
• Yu S, Shen W, Yu L, et al. Safety and efficacy of once-daily hydromorphone extended-release versus twice-daily oxycodone hydrochloride controlled-release in Chinese patients with cancer pain: a phase 3, randomized, double-blind, multicenter study. J Pain. 2014;15(8):835–844.
   PubMed Web of Science ®Google Scholar
• Markenson JA, Croft J, Zhang PG, et al. Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial. Clin J Pain. 2005;21(6):524–535.
   PubMed Web of Science ®Google Scholar
• Niesters M, Proto PL, Aarts L, et al. Tapentadol potentiates descending pain inhibition in chronic pain patients with diabetic polyneuropathy. Br J Anaesth. 2014;113(1):148–156.
   PubMed Web of Science ®Google Scholar
• Fishman RL, Kistler CJ, Ellerbusch MT, et al. Efficacy and safety of 12 weeks of osteoarthritic pain therapy with once-daily tramadol (Tramadol Contramid OAD). J Opioid Manag. 2007;3(5):273–280.
   PubMedGoogle Scholar
• Peloso PM, Bellamy N, Bensen W, et al. Double blind randomized placebo control trial of controlled release codeine in the treatment of osteoarthritis of the hip or knee. J Rheumatol. 2000;27(3):764–771.
   PubMed Web of Science ®Google Scholar
• Rauck R, Rapoport R, Thipphawong J. Results of a double-blind, placebo-controlled, fixed-dose assessment of once-daily OROS® hydromorphone ER in patients with moderate to severe pain associated with chronic osteoarthritis. Pain Pract. 2013;13(1):18–29.
   PubMed Web of Science ®Google Scholar
• Ueberall MA, Mueller-Schwefe GH. Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine for the treatment of chronic low back pain: results of a 12 week prospective, randomized, open-label blinded endpoint streamlined study with prolonged-release preparations. Curr Med Res Opin. 2015;31(7):1413–1429.
   PubMed Web of Science ®Google Scholar
• Caldwell JR, Rapoport RJ, Davis JC, et al. Efficacy and safety of a once-daily morphine formulation in chronic, moderate-to-severe osteoarthritis pain: results from a randomized, placebo-controlled, double-blind trial and an open-label extension trial. J Pain Symptom Manage. 2002;23(4):278–291.
   PubMed Web of Science ®Google Scholar
• 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 active-controlled phase III study. Clin Drug Investig. 2010;30(8):489–505.
   PubMed Web of Science ®Google Scholar
• Arbaiza D, Vidal O. Tramadol in the treatment of neuropathic cancer pain: a double-blind, placebo-controlled study. Clin Drug Investig. 2007;27(1):75–83.
   PubMed Web of Science ®Google Scholar
• Babul N, Noveck R, Chipman H, et al. Efficacy and safety of extended-release, once-daily tramadol in chronic pain: a randomized 12-week clinical trial in osteoarthritis of the knee. J Pain Symptom Manage. 2004;28(1):59–71.
   PubMed Web of Science ®Google Scholar
• 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. [Erratum appears in Expert Opin Pharmacother. 2010 Nov;11(16):2773]. Expert Opin Pharmacother. 2010;11(11):1787–1804.
   PubMed Web of Science ®Google Scholar
• Chu LF, D’Arcy N, Brady C, et al. Analgesic tolerance without demonstrable opioid-induced hyperalgesia: a double-blinded, randomized, placebo-controlled trial of sustained-release morphine for treatment of chronic nonradicular low-back pain. Pain. 2012;153(8):1583–1592.
   PubMed Web of Science ®Google Scholar
• Corli O, Floriani I, Roberto A, et al. Are strong opioids equally effective and safe in the treatment of chronic cancer pain? A multicenter randomized phase IV ‘real life’ trial on the variability of response to opioids. Ann Oncol. 2016;27(6):1107–1115.
   PubMed Web of Science ®Google Scholar
• Gana TJ, Pascual MLG, Fleming RRB, et al. Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial. Curr Med Res Opin. 2006;22(7):1391–1401.
   PubMed Web of Science ®Google Scholar
• Hale M, Tudor IC, Khanna S, et al. Efficacy and tolerability of once-daily OROS hydromorphone and twice-daily extended-release oxycodone in patients with chronic, moderate to severe osteoarthritis pain: results of a 6-week, randomized, open-label, noninferiority analysis. Clin Ther. 2007;29(5):874–888.
   PubMed Web of Science ®Google Scholar
• Matsumoto AK, Babul N, Ahdieh H. Oxymorphone extended-release tablets relieve moderate to severe pain and improve physical function in osteoarthritis: results of a randomized, double-blind, placebo- and active-controlled phase III trial. Pain Med. 2005;6(5):357–366.
   PubMed Web of Science ®Google Scholar
• Mayorga AJ, Wang S, Kelly KM, et al. Efficacy and safety of fulranumab as monotherapy in patients with moderate to severe, chronic knee pain of primary osteoarthritis: a randomized, placebo- and active-controlled trial. Int J Clin Pract. 2016;70(6):493–505.
   PubMed Web of Science ®Google Scholar
• Janssen-Cilag International NV. Placebo-controlled trial with OROS hydromorphone hydrochloride to treat patients with moderate to severe pain induced by osteoarthritis of the hip or the knee. Bethesda (MD): US National Library of Medicine; 2008.
   Google Scholar
• Johnson & Johnson Pharmaceutical Research & Development LLC. A long-term safety study with tapentadol ER and oxycodone CR in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN). Bethesda (MD): US National Library of Medicine; 2010.
   Google Scholar
• Janssen Pharmaceutical. An efficacy and safety study for tapentadol extended release (JNS024ER) in chronic pain participants. Bethesda (MD): US National Library of Medicine; 2010.
   Google Scholar
• Janssen Pharmaceutical. A phase 2 study of tapentadol extended-release (JNS024ER)) in Japanese participants with chronic pain due to diabetic neuropathic pain or postherpetic neuralgia. Bethesda (MD): US National Library of Medicine; 2010.
   Google Scholar
• Rauck RL, Bookbinder SA, Bunker TR, et al. The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain. J Opioid Manag. 2006;2(3):155–166.
   PubMedGoogle Scholar
• Serrie A, Lange B, Steup A. Tapentadol prolonged-release for moderate-to-severe chronic osteoarthritis knee pain: a double-blind, randomized, placebo- and oxycodone controlled release-controlled study. Curr Med Res Opin. 2017;33(8):1423–1432.
   PubMed Web of Science ®Google Scholar
• Spierings EL, Fidelholtz J, Wolfram G, et al. A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain. 2013;154(9):1603–1612.
   PubMed Web of Science ®Google Scholar
• Wild JE, Grond S, Kuperwasser B, et al. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract. 2010;10(5):416–427.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Hale ME, Ahdieh H, Ma T, et al. Efficacy and safety of OPANA ER (oxymorphone extended release) for relief of moderate to severe chronic low back pain in opioid-experienced patients: a 12-week, randomized, double-blind, placebo-controlled study. J Pain. 2007;8(2):175–184.
   PubMed Web of Science ®Google Scholar
• Rauck RL, Nalamachu S, Wild JE, et al. Single-entity hydrocodone extended-release capsules in opioid-tolerant subjects with moderate-to-severe chronic low back pain: a randomized double-blind, placebo-controlled study. Pain Med. 2014;15(6):975–985.
   PubMed Web of Science ®Google Scholar
• Hale ME, Zimmerman TR, Eyal E, et al. Efficacy and safety of a hydrocodone extended-release tablet formulated with abuse-deterrence technology in patients with moderate-to-severe chronic low back pain. J Opioid Manag. 2015;11(6):507–518.
   PubMedGoogle Scholar
• Hale ME, Laudadio C, Yang R, et al. Efficacy and tolerability of a hydrocodone extended-release tablet formulated with abuse-deterrence technology for the treatment of moderate-to-severe chronic pain in patients with osteoarthritis or low back pain. J Pain Res. 2015;8:623–636.
   PubMed Web of Science ®Google Scholar
• Kress HG, Koch ED, Kosturski H, et al. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician. 2014;17(4):329–343.
   PubMed Web of Science ®Google Scholar
• Purdue Pharma LP. Efficacy and safety of hydrocodone bitartrate (HYD) in subjects with moderate to severe chronic low back pain. Bethesda (MD): US National Library of Medicine; 2011.
   Google Scholar
• Bartoli A, Michna E, He E, et al. Efficacy and safety of once-daily, extended-release hydrocodone in individuals previously receiving hydrocodone/acetaminophen combination therapy for chronic pain. Postgrad Med. 2015;127(1):5–12.
   PubMed Web of Science ®Google Scholar
• Hale M, Khan A, Kutch M, et al. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain.[Erratum appears in Curr Med Res Opin. 2010 Aug;26(8):1904]. Curr Med Res Opin. 2010;26(6):1505–1518.
   PubMed Web of Science ®Google Scholar
• Burch F, Fishman R, Messina N, et al. A comparison of the analgesic efficacy of tramadol contramid OAD versus placebo in patients with pain due to osteoarthritis. J Pain Symptom Manage. 2007;34(3):328–338.
   PubMed Web of Science ®Google Scholar
• Friedmann N, Klutzaritz V, Webster L. Efficacy and safety of an extended-release oxycodone (remoxy) formulation in patients with moderate to severe osteoarthritic pain. J Opioid Manag. 2011;7(3):193–202.
   PubMedGoogle Scholar
• Gimbel J, Spierings EL, Katz N, et al. Efficacy and tolerability of buccal buprenorphine in opioid-experienced patients with moderate to severe chronic low back pain: results of a phase 3, enriched enrollment, randomized withdrawal study.[Erratum appears in Pain. 2017 Feb;158(2):366; PMID: 28092653]. Pain. 2016;157(11):2517–2526.
   PubMed Web of Science ®Google Scholar
• Katz N, Rauck R, Ahdieh H, et al. A 12-week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opioid-naive patients with chronic low back pain. Curr Med Res Opin. 2007;23(1):117–128.
   PubMed Web of Science ®Google Scholar
• Katz N, Kopecky EA, O’Connor M, et al. A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. Pain. 2015;156(12):2458–2467.
   PubMed Web of Science ®Google Scholar
• Rauck RL, Potts J, Xiang Q, et al. Efficacy and tolerability of buccal buprenorphine in opioid-naive patients with moderate to severe chronic low back pain. Postgrad Med. 2016;128(1):1–11.
   PubMed Web of Science ®Google Scholar
• Schnitzer TJ, Gray WL, Paster RZ, et al. Efficacy of tramadol in treatment of chronic low back pain. J Rheumatol. 2000;27(3):772–778.
   PubMed Web of Science ®Google Scholar
• 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(1):151–162.
   PubMed Web of Science ®Google Scholar
• Vinik AI, Shapiro DY, Rauschkolb C, et al. A randomized withdrawal, placebo-controlled study evaluating the efficacy and tolerability of tapentadol extended release in patients with chronic painful diabetic peripheral neuropathy. Dia Care. 2014;37(8):2302–2309.
   PubMed Web of Science ®Google Scholar
• Vorsanger GJ, Xiang J, Gana TJ, et al. Extended-release tramadol (tramadol ER) in the treatment of chronic low back pain. J Opioid Manag. 2008;4(2):87–97.
   PubMedGoogle Scholar
• Kawamata M, Iseki M, Kawakami M, et al. Efficacy and safety of controlled-release oxycodone for the management of moderate-to-severe chronic low back pain in Japan: results of an enriched enrollment randomized withdrawal study followed by an open-label extension study. J Pain Res. 2019;12:363–375.
   PubMed Web of Science ®Google Scholar
• Riemsma R, Forbes C, Harker J, et al. Systematic review of tapentadol in chronic severe pain. Curr Med Res Opin. 2011;27(10):1907–1930.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Impact of impaired access to controlled medications. Geneva (Switzerland): WHO; 2020 [Cited 2020 August 21]. Available from: https://www.who.int/medicines/areas/quality_safety/Impaired_Access/en/
   Google Scholar
• D’Amato T, Martorelli F, Fenocchio G, et al. Tapentadol vs oxycodone/naloxone in the management of pain after total hip arthroplasty in the fast track setting: an observational study. J Exp Orthop. 2019;6(1):36.
   PubMedGoogle Scholar
• Rian T, Skogvoll E, Hofstad J, et al. Tapentadol versus oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial. Pain. 2020. DOI:https://doi.org/10.1097/j.pain.0000000000002026
   Web of Science ®Google Scholar
• Meng Z, Yu J, Acuff M, et al. Tolerability of opioid analgesia for chronic pain: a network meta-analysis. Sci Rep. 2017;7(1):1995.
   PubMed Web of Science ®Google Scholar
• Raff RB, Elling C, Tzschentke TM. Does ‘strong analgesic’ equal ‘strong opioid’? Tapentadol and the concept of ‘µ-load’. Adv Ther. 2018;35(10):1471–1484.
   PubMed Web of Science ®Google Scholar
• Meske DS, Lawal OD, Elder H, et al. Efficacy of opioids versus placebo in chronic pain: a systematic review and meta-analysis of enriched enrollment randomized withdrawal trials. J Pain Res. 2018;11:923–934.
   PubMed Web of Science ®Google Scholar
• Coluzzi F, Fornasari D, Pergolizzi J, et al. From acute to chronic pain: tapentadol in the progressive stages of this disease entity. Eur Rev Med Pharmacol Sci. 2017;21(7):1672–1683.
   PubMed Web of Science ®Google Scholar
• Langford RM, Knaggs R, Farquhar-Smith P, et al. Is tapentadol different from classical opioids? A review of the evidence. Br J Pain. 2016;10(4):217–221.
   PubMed Web of Science ®Google Scholar
• Buckley NA, Dawson AH, Isbister GK. Serotonin syndrome. BMJ. 2014;348:g1626.
   PubMed Web of Science ®Google Scholar
• Sun-Edelstein C, Tepper SJ, Shapiro RE. Drug-induced serotonin syndrome: a review. Expert Opin Drug Saf. 2008;7(5):587–596.
   PubMed Web of Science ®Google Scholar
• Gillman PK. Monoamine oxidase inhibitors, opioid analgesics and serotonin toxicity. Br J Anaesth. 2005;95(4):434–441.
   PubMed Web of Science ®Google Scholar
• Gov.uk [Internet]. Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines. London (UK): Government Digital Service; 2019 [updated 2019 January 09; cited 2020 January 03]. Available from: https://www.gov.uk/drug-safety-update/tapentadol-palexia-risk-of-seizures-and-reports-of-serotonin-syndrome-when-co-administered-with-other-medicines
   Google Scholar
• Stollenwerk A, Sohns M, Heisig F, et al. Review of post-marketing safety data on tapentadol, a centrally acting analgesic. Adv Ther. 2018;35(1):12–30.
   PubMed Web of Science ®Google Scholar
• Busse JW, Wang L, Kamaleldin M, et al. Opioids for chronic noncancer pain: a systematic review and meta-analysis. JAMA. 2018;320(23):2448–2460.
   PubMed Web of Science ®Google Scholar