Prospective, non-interventional study on the tolerability and analgesic effectiveness over 12 weeks after a single application of capsaicin 8% cutaneous patch in 1044 patients with peripheral neuropathic pain: first results of the QUEPP study

References

• Attal N. Neuropathic pain: mechanisms, therapeutic approach, and interpretation of clinical trials. Continuum (Minneap Minn) 2012;18:161-75
   PubMedGoogle Scholar
• Vorobeychik Y, Gordin V, Mao J, et al. Combination therapy for neuropathic pain: a review of current evidence. CNS Drugs 2011;25:1023-34
   PubMed Web of Science ®Google Scholar
• Shaladi AM, Saltari MR, Crestani F, et al. Post-surgical neuropathic pain. Recenti Prog Med 2009;100:371-379
   PubMedGoogle Scholar
• Sadosky A, McDermott AM, Brandenburg NA, et al. A review of the epidemiology of painful diabetic peripheral neuropathy, postherpetic neuralgia, and less commonly studied neuropathic pain conditions. Pain Pract 2008;8:45-56
   PubMedGoogle Scholar
• Edelsberg J, Lord C, Oster G. Systematic review and meta-analysis of efficacy, safety, and tolerability data from randomized controlled trials of drugs used to treat postherpetic neuralgia. Ann Pharmacother 2011;45:1483-90
   PubMed Web of Science ®Google Scholar
• Hahn K, Husstedt IW. HIV-associated neuropathies. Nervenarzt 2010;81:409-17
   PubMed Web of Science ®Google Scholar
• McCormack PL. Capsaicin dermal patch: in non-diabetic peripheral neuropathic pain. Drugs 2010;70:1831-42
   PubMed Web of Science ®Google Scholar
• Cortright D, Szallasi A. TRP channels and pain. Curr Pharm Des 2009;15:1736-49
   PubMed Web of Science ®Google Scholar
• Derry S, Lloyd R, Moore RA, et al. Topical capsaicin for chronic neuropathic pain in adults. Cochrane Database Syst Rev 2009;4:CD007393
   PubMed Web of Science ®Google Scholar
• Malmberg AB, Mizisin AP, Calcutt NA, et al. Reduced heat sensitivity and epidermal nerve fiber immunostaining following single applications of a high-concentration capsaicin patch. Pain 2004;111:360-7
   PubMed Web of Science ®Google Scholar
• Kennedy WR, Vanhove GF, Lu S-P, et al. A randomized, controlled, open-label study of the long-term effects of NGX-4010, a high-concentration capsaicin patch, on epidermal nerve fiber density and sensory function in healthy volunteers. J Pain 2010;11:579-87
   PubMed Web of Science ®Google Scholar
• Irving GA, Backonja M, Rauck R, et al. NGX-4010, a capsaicin 8% dermal patch, administered alone or in combination with systemic neuropathic pain medications, reduces pain in patients with postherpetic neuralgia. Clin J Pain 2012;28:101-7
   PubMed Web of Science ®Google Scholar
• Simpson DM, Gazda S, Brown S, et al. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J Pain Symptom Manage 2010;39:1053-64
   PubMed Web of Science ®Google Scholar
• Clifford DB, Simpson DM, Brown S et al. A randomized, double-blind, controlled study of NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. J Acquir Immune Defic Syndr 2012;59:126--33
   Google Scholar
• Martini C, Yassen A, Olofsen E, et al. Pharmacodynamic analysis of the analgesic effect of capsaicin 8% patch (Qutenza) in diabetic neuropathic pain patients: detection of distinct response groups. J Pain Res 2012;5:51-9
   PubMedGoogle Scholar
• VFA NIS Datenbank. NIS Database of the Research-based Pharmaceutical Companies in Germany (2010). Availabe at: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_599 [Last accessed 30 January 2013]
   Google Scholar
• Qutenza 179mg cutaneous patch – Summary of Product Characteristics (SPC) – (eMC). Available at: http://www.medicines.org.uk/emc/medicine/23156/SPC/qutenza%20179mg%20cutaneous%20patch/ [Last accessed 29 March 2012]
   Google Scholar
• Cochrane-Glossar | Das Deutsche Cochrane Zentrum. Available at: http://www.cochrane.de/de/cochrane-glossar#e [Last accessed 25 February 2013]
   Google Scholar
• Gandek B, Ware JE, Aaronson NK, et al. Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment. J Clin Epidemiol 1998;51:1171-8
   PubMed Web of Science ®Google Scholar
• Freynhagen R, Baron R, Gockel U, et al. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin 2006;22:1911-20
   PubMed Web of Science ®Google Scholar
• Stammschulte T, Pachl H, Gundert-Remy U et al. Einführung in die Grundlagen der Pharmakovigilanz (Teil II): Spontanmeldesystem zur Erfassung von Verdachtsfällen unerwünschter Arzneimittelwirkungen (UAW). Bulletin zur Arzneimittelsicherheit. Informationen aus BfArM und PEI 2010;4:18--26
   Google Scholar
• Treede R-D, Wagner T, Kern U, et al. Mechanism- and experience-based strategies to optimize treatment response to the capsaicin 8% cutaneous patch in patients with localized neuropathic pain. Accepted for publication. Curr Med Res Opin 2013;29:527--38
   PubMed Web of Science ®Google Scholar
• Jones VM, Moore KA, Peterson DM, et al. Capsaicin 8% topical patch (Qutenza) – a review of the evidence. J Pain Palliat Care Pharmacother 2011;25:32-41
   PubMedGoogle Scholar
• Irving GA, Backonja MM, Dunteman E, et al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med 2011;12:99-109
   PubMed Web of Science ®Google Scholar
• Webster L, Peppin J, Murphy F, et al. Efficacy, safety, and tolerability of NGX-4010, capsaicin 8% patch, in an open-label study of patients with peripheral neuropathic pain. Diabetes Res Clin Pract 2011;93:187-97
   PubMed Web of Science ®Google Scholar
• Backonja MM, Malan TP, Vanhove GF, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomized, double-blind, controlled study with an open-label extension. Pain Med 2010;11:600-8
   PubMed Web of Science ®Google Scholar
• Webster LR, Malan TP, Tuchman MM, et al. A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. J Pain 2010;11:972-82
   PubMed Web of Science ®Google Scholar
• Webster L, Tark M, Rauck R, et al. Effect of duration of postherpetic neuralgia on efficacy analyses in a multicenter, randomized, controlled study of NGX-4010, an 8% capsaicin patch evaluated for the treatment of postherpetic neuralgia. BMC Neurol 2010;10:92
   PubMed Web of Science ®Google Scholar
• Backonja M, Wallace MS, Blonsky ER, et al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol 2008;7:1106-12
   PubMed Web of Science ®Google Scholar
• Simpson DM, Brown S, Tobias, J. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology 2008;70:2305-13
   PubMed Web of Science ®Google Scholar
• Klinger R, Matter N, Kothe R, et al. Unconditioned and conditioned muscular responses in patients with chronic back pain and chronic tension-type headaches and in healthy controls. Pain 2010;150:66-74
   PubMed Web of Science ®Google Scholar
• Finnerup N, Sindrup S, Jensen T. The evidence for pharmacological treatment of neuropathic pain. Pain 2010;150:573-81
   PubMed Web of Science ®Google Scholar
• Deligianni CI, Vikelis M, Mitsikostas DD. Depression in headaches: chronification. Curr Opin Neurol 2012;25:277-83
   PubMed Web of Science ®Google Scholar
• Holzer P. The pharmacological challenge to tame the transient receptor potential vanilloid-1 (TRPV1) nocisensor. Br J Pharmacol 2008;155:1145-62
   PubMed Web of Science ®Google Scholar
• Baron R. Neuropathic pain: a clinical perspective. Handb Exp Pharmacol 2009;194:3-30
   PubMedGoogle Scholar
• Babbar S, Marier J-F, Mouksassi M-S, et al. Pharmacokinetic analysis of capsaicin after topical administration of a high-concentration capsaicin patch to patients with peripheral neuropathic pain. Ther Drug Monit 2009;31:502-10
   PubMed Web of Science ®Google Scholar
• Anand P, Bley K. Topical capsaicin for pain management: therapeutic potential and mechanisms of action of the new high-concentration capsaicin 8% patch. Br J Anaesth 2011;107:490-502
   PubMed Web of Science ®Google Scholar
• Gerbershagen K, Gerbershagen HJ, Lutz J, et al. Pain prevalence and risk distribution among inpatients in a German teaching hospital. Clin J Pain 2009;25:431-7
   PubMed Web of Science ®Google Scholar
• Peppin J, Majors K, Webster L, et al. Tolerability of NGX-4010, a capsaicin 8% patch for peripheral neuropathic pain. J Pain Res 2011;4:385-92
   PubMedGoogle Scholar
• Kasting GB. Kinetics of finite dose absorption through skin 1. Vanillylnonanamide. J Pharm Sci 2001;90:202-12
   PubMed Web of Science ®Google Scholar
• Chanda S, Bashir M, Babbar S, et al. In vitro hepatic and skin metabolism of capsaicin. Drug Metab Dispos 2008;36:670-5
   PubMed Web of Science ®Google Scholar
• Patane S, Marte F, La Rosa FC, et al. Capsaicin and arterial hypertensive crisis. Int J Cardiol 2010;144:e26-7
   PubMed Web of Science ®Google Scholar
• Akçay AB, Ozcan T, Seyis S, et al. Coronary vasospasm and acute myocardial infarction induced by a topical capsaicin patch. Turk Kardiyol Dern Ars 2009;37:497-500
   PubMedGoogle Scholar
• European Medicines Agency. ICH Topic E 6 (R1). Guideline for Good Clinical Practice, Step 5. 2002
   Google Scholar
• Simpson DM, Brown S, Tobias JK et al. NGX-4010, a capsaicin 8% dermal patch, for the treatment of painful HIV-associated distal sensory polyneuropathy. Results of a 52-week open-label study. Clin J Pain 2013 Feb 26. Epub ahead of print
   Google Scholar