Quality of Life and Functional Outcomes with Tapentadol Prolonged Release in Chronic Musculoskeletal Pain: Post Hoc Analysis

References

• GBD 2017 DALYs and HALE Collaborators . Global, regional, and national disability-adjusted life-years (DALYs) for 359 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet392(10159), 1859–1922 (2018).
   PubMed Web of Science ®Google Scholar
• Blyth FM , HuckelSchneider C. Global burden of pain and global pain policy-creating a purposeful body of evidence. Pain159(Suppl. 1), S43–S48 (2018).
   PubMedGoogle Scholar
• Manchikanti L , SinghV , DattaS , CohenSP , HirschJA. Comprehensive review of epidemiology, scope, and impact of spinal pain. Pain Physician12(4), E35–70 (2009).
   PubMed Web of Science ®Google Scholar
• Hurwitz EL , RandhawaK , YuH , CôtéP , HaldemanS. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur. Spine J.27(Suppl. 6), 796–801 (2018).
   PubMedGoogle Scholar
• Meucci RD , FassaAG , FariaNM. Prevalence of chronic low back pain: systematic review. Rev. Saude Publica.49, 1 (2015).
   PubMed Web of Science ®Google Scholar
• Urits I , BurshteinA , SharmaMet al. Low back pain, a comprehensive review: pathophysiology, diagnosis, and treatment. Curr. Pain Headache Rep.23(3), 23 (2019).
   PubMed Web of Science ®Google Scholar
• Margarit C . The impact of pain; results of a survey in big 5 EU countries. (2011). https://www.sip-platform.eu/resources/details/sip-2011-plenary-session-3-may-the-impact-of-pain
   Google Scholar
• Manchikanti L , SinghV , FalcoFJ , BenyaminRM , HirschJA. Epidemiology of low back pain in adults. Neuromodulation17(Suppl. 2), 3–10 (2014).
   PubMed Web of Science ®Google Scholar
• Fatoye F , GebryeT , OdeyemiI. Real-world incidence and prevalence of low back pain using routinely collected data. Rheumatol. Int.39(4), 619–626 (2019).
   PubMed Web of Science ®Google Scholar
• Shmagel A , FoleyR , IbrahimH. Epidemiology of chronic low back pain in US adults: data from the 2009–2010 National Health and Nutrition Examination Survey. Arthritis Care Res. (Hoboken)68(11), 1688–1694 (2016).
   PubMed Web of Science ®Google Scholar
• Todd A , McNamaraCL , BalajMet al. The European epidemic: pain prevalence and socioeconomic inequalities in pain across 19 European countries. Eur. J. Pain23(8), 1425–1436 (2019).
   PubMed Web of Science ®Google Scholar
• Lawrence RC , FelsonDT , HelmickCGet al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum.58(1), 26–35 (2008).
   PubMed Web of Science ®Google Scholar
• WHO Scientific Group . The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ. Tech. Rep. Ser.919, i–x1–218; back cover (2003).
   Web of Science ®Google Scholar
• Murphy L , SchwartzTA , HelmickCGet al. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum.59(9), 1207–1213 (2008).
   PubMed Web of Science ®Google Scholar
• Woolf AD . The bone and joint decade. Strategies to reduce the burden of disease: the Bone and Joint Monitor Project. J. Rheumatol. Suppl.67, 6–9 (2003).
   PubMedGoogle Scholar
• Andrews P , SteultjensM , RiskowskiJ. Chronic widespread pain prevalence in the general population: a systematic review. Eur. J. Pain.22(1), 5–18 (2018).
   PubMed Web of Science ®Google Scholar
• Mundal I , GraweRW , BjorngaardJH , LinakerOM , ForsEA. Prevalence and long-term predictors of persistent chronic widespread pain in the general population in an 11-year prospective study: the HUNT study. BMC Musculoskelet. Disord.15, 213 (2014).
   PubMed Web of Science ®Google Scholar
• Fayaz A , CroftP , LangfordRM , DonaldsonLJ , JonesGT. Prevalence of chronic pain in the UK: a systematic review and meta-analysis of population studies. BMJ Open6(6), e010364 (2016).
   PubMed Web of Science ®Google Scholar
• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators . Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet392(10159), 1789–1858 (2018).
   PubMed Web of Science ®Google Scholar
• Mills SEE , NicolsonKP , SmithBH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br. J. Anaesth.123(2), e273–e283 (2019).
   PubMed Web of Science ®Google Scholar
• Lambeek LC , van TulderMW , SwinkelsIC , KoppesLL , AnemaJR , van MechelenW. The trend in total cost of back pain in The Netherlands in the period 2002 to 2007. Spine (Phila Pa 1976)36(13), 1050–1058 (2011).
   PubMed Web of Science ®Google Scholar
• Hansson EK , HanssonTH. The costs for persons sick-listed more than one month because of low back or neck problems. A two-year prospective study of Swedish patients. Eur. Spine J.14(4), 337–345 (2005).
   PubMed Web of Science ®Google Scholar
• Hartvigsen J , HancockMJ , KongstedAet al. What low back pain is and why we need to pay attention. Lancet391(10137), 2356–2367 (2018).
   PubMed Web of Science ®Google Scholar
• Stewart WF , RicciJA , CheeE , MorgansteinD , LiptonR. Lost productive time and cost due to common pain conditions in the US workforce. JAMA290(18), 2443–2454 (2003).
   PubMed Web of Science ®Google Scholar
• Werner EL , CoteP. Low back pain and determinants of sickness absence. Eur. J. Gen. Pract.15(2), 74–79 (2009).
   PubMed Web of Science ®Google Scholar
• Lim YZ , ChouL , AuRTet al. People with low back pain want clear, consistent and personalised information on prognosis, treatment options and self-management strategies: a systematic review. J. Physiother.65(3), 124–135 (2019).
   PubMed Web of Science ®Google Scholar
• World Health Organization . Cancer pain relief, second edition. http://apps.who.int/iris/bitstream/10665/37896/1/9241544821.pdf
   Google Scholar
• Manchikanti L , KayeAM , KnezevicNNet al. Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician20(2s), S3–S92 (2017).
   PubMed Web of Science ®Google Scholar
• Schug SA . Not all opioids are the same. Medicine Today19(Suppl. 9), 2–4 (2018).
   Google Scholar
• Raffa RB . On subclasses of opioid analgesics. Curr. Med. Res. Opin.30(12), 2579–2584 (2014).
   PubMed Web of Science ®Google Scholar
• Pergolizzi JV Jr , LeQuangJA , BergerGK , RaffaRB. The basic pharmacology of opioids informs the opioid discourse about misuse and abuse: a review. Pain Ther.6(1), 1–16 (2017).
   PubMed Web of Science ®Google Scholar
• Argoff C . Mechanisms of pain transmission and pharmacologic management. Curr. Med. Res. Opin.27(10), 2019–2031 (2011).
   PubMed Web of Science ®Google Scholar
• Kress HG . Tapentadol and its two mechanisms of action: is there a new pharmacological class of centrally-acting analgesics on the horizon?Eur. J. Pain.14(8), 781–783 (2010).
   PubMed Web of Science ®Google Scholar
• Schroder W , VryJD , TzschentkeTM , JahnelU , ChristophT. Differential contribution of opioid and noradrenergic mechanisms of tapentadol in rat models of nociceptive and neuropathic pain. Eur. J. Pain.14(8), 814–821 (2010).
   PubMed Web of Science ®Google Scholar
• Schroder W , TzschentkeTM , TerlindenRet al. Synergistic interaction between the two mechanisms of action of tapentadol in analgesia. J. Pharmacol. Exp. Ther.337(1), 312–320 (2011).
   PubMed Web of Science ®Google Scholar
• Langford RM , KnaggsR , Farquhar-SmithP , DickensonAH. Is tapentadol different from classical opioids? A review of the evidence. Br. J. Pain.10(4), 217–221 (2016).
   PubMed Web of Science ®Google Scholar
• Afilalo M , EtropolskiMS , KuperwasserBet 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.30(8), 489–505 (2010).
   PubMed Web of Science ®Google Scholar
• Schwartz S , EtropolskiM , ShapiroDYet 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.27(1), 151–162 (2011).
   PubMed Web of Science ®Google Scholar
• Baron R , LikarR , Martin-MolaEet 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.16(5), 580–599 (2016).
   PubMed Web of Science ®Google Scholar
• Kress HG , KochED , KosturskiHet al. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician17(4), 329–343 (2014).
   PubMed Web of Science ®Google Scholar
• Beuter C , VolkersG , RadicT , GoldbergJ , vanden Anker J. Efficacy and safety of multiple doses of tapentadol oral solution in the treatment of moderate to severe acute pain in children aged 2 to <18 years - a randomized, double-blind, placebo-controlled trial. J. Pain Res.12, 3099–3112 (2019).
   PubMed Web of Science ®Google Scholar
• Coluzzi F , PolatiE , FreoU , GrilliM. Tapentadol: an effective option for the treatment of back pain. J. Pain Res.12, 1521–1528 (2019).
   PubMed Web of Science ®Google Scholar
• Palexia prolonged release tablets . Summary of product characteristics. https://www.medicines.org.uk/emc/product/5158/smpc
   Google Scholar
• Nucynta extended-release tablets PiD. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf
   Google Scholar
• Dansie EJ , TurkDC , MartinKR , van DomelenDR , PatelKV. Association of chronic widespread pain with objectively measured physical activity in adults: findings from the National Health and Nutrition Examination survey. J. Pain15(5), 507–515 (2014).
   PubMed Web of Science ®Google Scholar
• Duenas M , OjedaB , SalazarA , MicoJA , FaildeI. A review of chronic pain impact on patients, their social environment and the health care system. J. Pain Res.9, 457–467 (2016).
   PubMed Web of Science ®Google Scholar
• Katz N . The impact of pain management on quality of life. J. Pain Symptom Manag.24(Suppl. 1), S38–S47 (2002).
   PubMed Web of Science ®Google Scholar
• Nelson AD , CamilleriM. Opioid-induced constipation: advances and clinical guidance. Ther. Adv. Chronic Dis.7(2), 121–134 (2016).
   PubMed Web of Science ®Google Scholar
• Patel KV , DansieEJ , TurkDC. Impact of chronic musculoskeletal pain on objectively measured daily physical activity: a review of current findings. Pain Manag.3(6), 467–474 (2013).
   PubMedGoogle Scholar
• Schug SA , PalmerGM , ScottDA , HalliwellR , TrincaJ. Acute Pain Management: Scientific Evidence fourth edition, 2015. Med. J. Aust.204(8), 315–317 (2016).
   PubMed Web of Science ®Google Scholar
• Ware JE Jr , SherbourneCD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med. Care30(6), 473–483 (1992).
   PubMed Web of Science ®Google Scholar
• Panella L , RinonapoliG , CoaccioliS. Where should analgesia lead to? Quality of life and functional recovery with tapentadol. J. Pain Res.12, 1561–1567 (2019).
   PubMed Web of Science ®Google Scholar
• Hofmann JF , LalA , SteffensM , BoettgerR. Patient-relevant outcomes and health-related quality of life in patients with chronic, severe, noncancer pain treated with tapentadol prolonged release-Using criteria of health technology assessment. J. Opioid Manag.12(5), 323–331 (2016).
   PubMedGoogle Scholar
• Lange B , KuperwasserB , OkamotoAet al. Efficacy and safety of tapentadol prolonged release for chronic osteoarthritis pain and low back pain. Adv. Ther.27(6), 381–399 (2010).
   PubMed Web of Science ®Google Scholar
• Lange B , von ZabernD , EllingC , DuboisC. Efficacy and safety of tapentadol prolonged release for moderate-to-severe chronic osteoarthritis knee pain: a pooled analysis of two double-blind, randomized, placebo- and oxycodone controlled release-controlled studies. Curr. Med. Res. Opin.33(8), 1413–1422 (2017).
   PubMed Web of Science ®Google Scholar
• Noble M , TreadwellJR , TregearSJet al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst. Rev.2010(1), Cd006605 (2010).
   PubMed Web of Science ®Google Scholar
• Buynak R , ShapiroDY , OkamotoAet 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.11(11), 1787–1804 (2010).
   PubMed Web of Science ®Google Scholar
• Nugraha B , GutenbrunnerC , BarkeAet al. The IASP classification of chronic pain for ICD-11: functioning properties of chronic pain. Pain160(1), 88–94 (2019).
   PubMed Web of Science ®Google Scholar
• Afilalo M , MorlionB. Efficacy of tapentadol ER for managing moderate to severe chronic pain. Pain Physician16(1), 27–40 (2013).
   PubMed Web of Science ®Google Scholar
• Sanchez Del Aguila MJ , SchenkM , KernKU , DrostT , SteigerwaldI. Practical considerations for the use of tapentadol prolonged release for the management of severe chronic pain. Clin. Ther.37(1), 94–113 (2015).
   PubMed Web of Science ®Google Scholar
• Freynhagen R , BaronR , GockelU , TölleTR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr. Med. Res. Opin.22(10), 1911–1920 (2006).
   PubMed Web of Science ®Google Scholar
• Mehra M , HillK , NichollD , SchadrackJ. The burden of chronic low back pain with and without a neuropathic component: a healthcare resource use and cost analysis. J. Med. Econ.15(2), 245–252 (2012).
   PubMedGoogle Scholar
• Freynhagen R , BaronR , TölleTet al. Screening of neuropathic pain components in patients with chronic back pain associated with nerve root compression: a prospective observational pilot study (MIPORT). Curr. Med. Res. Opin.22(3), 529–537 (2006).
   PubMed Web of Science ®Google Scholar
• O’Connor AB . Neuropathic pain: quality-of-life impact, costs and cost effectiveness of therapy. Pharmacoeconomics27(2), 95–112 (2009).
   PubMed Web of Science ®Google Scholar
• Borsook D , YoussefAM , SimonsL , ElmanI , EcclestonC. When pain gets stuck: the evolution of pain chronification and treatment resistance. Pain159(12), 2421–2436 (2018).
   PubMed Web of Science ®Google Scholar
• Kudel I , HoppsM , CappelleriJCet al. Characteristics of patients with neuropathic pain syndromes screened by the painDETECT questionnaire and diagnosed by physician exam. J. Pain Res.12, 255–268 (2019).
   PubMed Web of Science ®Google Scholar
• Spahr N , HodkinsonD , JollyK , WilliamsS , HowardM , ThackerM. Distinguishing between nociceptive and neuropathic components in chronic low back pain using behavioural evaluation and sensory examination. Musculoskelet. Sci. Pract.27, 40–48 (2017).
   PubMed Web of Science ®Google Scholar
• Ward MM , GuthrieLC , AlbaMI. Clinically important changes in short form 36 health survey scales for use in rheumatoid arthritis clinical trials: the impact of low responsiveness. Arthritis Care Res. (Hoboken)66(12), 1783–1789 (2014).
   PubMed Web of Science ®Google Scholar
• Baron R , JansenJP , BinderAet al. Tolerability, safety, and quality of life with tapentadol prolonged release (PR) compared with oxycodone/naloxone PR in patients with severe chronic low back pain with a neuropathic component: a randomized, controlled, open-label, Phase IIIb/IV trial. Pain Pract.16(5), 600–619 (2016).
   PubMed Web of Science ®Google Scholar
• Biondi D , XiangJ , BensonC , EtropolskiM , MoskovitzB , RauschkolbC. Tapentadol immediate release versus oxycodone immediate release for treatment of acute low back pain. Pain Physician16(3), E237–246 (2013).
   PubMed Web of Science ®Google Scholar
• Buynak R , RappaportSA , RodKet al. Long-term safety and efficacy of tapentadol extended release following up to 2 years of treatment in patients with moderate to severe, chronic pain: results of an open-label extension trial. Clin. Ther.37(11), 2420–2438 (2015).
   PubMed Web of Science ®Google Scholar
• Etropolski M , KellyK , OkamotoA , RauschkolbC. Comparable efficacy and superior gastrointestinal tolerability (nausea, vomiting, constipation) of tapentadol compared with oxycodone hydrochloride. Adv. Ther.28(5), 401–417 (2011).
   PubMed Web of Science ®Google Scholar
• Merchant S , ProvenzanoD , ModyS , HoKF , EtropolskiM. Composite measure to assess efficacy/gastrointestinal tolerability of tapentadol ER versus oxycodone CR for chronic pain: pooled analysis of randomized studies. J. Opioid Manag.9(1), 51–61 (2013).
   PubMedGoogle Scholar
• Wild JE , GrondS , KuperwasserBet al. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain. Pain Pract.10(5), 416–427 (2010).
   PubMed Web of Science ®Google Scholar