The Role of the Capsaicin 8% Patch in the Treatment of Painful Diabetic Peripheral Neuropathy

References

• Peltier AC , WoodD. Management of neuropathic pain in polyneuropathy. Continuum (Minneap. Minn.)26(5), 1299–1322 (2020).
   PubMedGoogle Scholar
• Khdour MR . Treatment of diabetic peripheral neuropathy: a review. J. Pharm. Pharmacol.72(7), 863–872 (2020).
   PubMed Web of Science ®Google Scholar
• van Nooten F , TreurM , PantiriK , StokerM , CharokopouM. Capsaicin 8% patch versus oral neuropathic pain medications for the treatment of painful diabetic peripheral neuropathy: a systematic literature review and network meta-analysis. Clin. Ther.39(4), 787–803.e718 (2017).
   PubMed Web of Science ®Google Scholar
• Tajti J , SzokD , MajláthZ , CsátiA , Petrovics-BalogA , VécseiL. Alleviation of pain in painful diabetic neuropathy. Expert Opin. Drug Metab. Toxicol.12(7), 753–764 (2016).
   PubMed Web of Science ®Google Scholar
• Gordois A , ScuffhamP , ShearerA , OglesbyA , TobianJA. The health care costs of diabetic peripheral neuropathy in the US. Diabetes Care26(6), 1790–1795 (2003).
   PubMed Web of Science ®Google Scholar
• Currie CJ , PooleCD , WoehlAet al. The financial costs of healthcare treatment for people with Type 1 or Type 2 diabetes in the UK with particular reference to differing severity of peripheral neuropathy. Diabet. Med.24(2), 187–194 (2007).
   PubMed Web of Science ®Google Scholar
• National Institute for Healthcare and Excellence . Neuropathic pain: the pharmacological management of neuropathic pain in adults in non-specialist settings [Internet]. (2013).
   Google Scholar
• Zilliox LA . Neuropathic pain. Continuum (Minneap. Minn.)23(2, Selected Topics in Outpatient Neurology), 512–532 (2017).
   PubMedGoogle Scholar
• Waldfogel JM , NesbitSA , DySMet al. Pharmacotherapy for diabetic peripheral neuropathy pain and quality of life: a systematic review. Neurology88(20), 1958–1967 (2017).
   PubMed Web of Science ®Google Scholar
• Finnerup NB , AttalN , HaroutounianSet al. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol.14(2), 162–173 (2015).
   PubMed Web of Science ®Google Scholar
• Russell JW , ZillioxLA. Diabetic neuropathies. Continuum (Minneap. Minn.)20(5, Peripheral Nervous System Disorders), 1226–1240 (2014).
   PubMedGoogle Scholar
• Attal N , CruccuG , BaronRet al. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur. J. Neurol.17(9), 1113–e1188 (2010).
   PubMed Web of Science ®Google Scholar
• Tesfaye S , VileikyteL , RaymanGet al. Painful diabetic peripheral neuropathy: consensus recommendations on diagnosis, assessment and management. Diabetes Metab. Res. Rev.27(7), 629–638 (2011).
   PubMed Web of Science ®Google Scholar
• Moisset X , BouhassiraD , AvezCouturier Jet al. Pharmacological and non-pharmacological treatments for neuropathic pain: systematic review and French recommendations. Rev. Neurol. (Paris)176(5), 325–352 (2020).
   PubMed Web of Science ®Google Scholar
• Zilliox L , RussellJW. Treatment of diabetic sensory polyneuropathy. Curr. Treat. Options Neurol.13(2), 143–159 (2011).
   PubMed Web of Science ®Google Scholar
• Fusco BM , GiacovazzoM. Peppers and pain. The promise of capsaicin. Drugs53(6), 909–914 (1997).
   PubMed Web of Science ®Google Scholar
• Srinivasan K . Biological activities of red pepper (Capsicum annuum) and its pungent principle capsaicin: a review. Crit. Rev. Food Sci. Nutr.56(9), 1488–1500 (2016).
   PubMed Web of Science ®Google Scholar
• European Medicines Agency . Summary of product characteristics: qutenza 179mg cutaneous patch (Original report 09/05/2009). (2009).
   Google Scholar
• Forst T , PohlmannT , KuntTet al. The influence of local capsaicin treatment on small nerve fibre function and neurovascular control in symptomatic diabetic neuropathy. Acta Diabetol.39(1), 1–6 (2002).
   PubMed Web of Science ®Google Scholar
• Kiani J , AhmadNasrollahi S , Esna-AshariF , FallahP , SajediF. Amitriptyline 2% cream vs. capsaicin 0.75% cream in the treatment of painful diabetic neuropathy (double-blind, randomized clinical trial of efficacy and safety). Iran J. Pharm. Res.14(4), 1263–1268 (2015).
   PubMed Web of Science ®Google Scholar
• Tandan R , LewisGA , KrusinskiPB , BadgerGB , FriesTJ. Topical capsaicin in painful diabetic neuropathy. Controlled study with long-term follow-up. Diabetes Care15(1), 8–14 (1992).
   PubMed Web of Science ®Google Scholar
• Capsaicin Study Group . Effect of treatment with capsaicin on daily activities of patients with painful diabetic neuropathy. Diabetes Care15(2), 159–165 (1992).
   PubMed Web of Science ®Google Scholar
• The Capsaicin Study Group . Treatment of painful diabetic neuropathy with topical capsaicin. A multicenter, double-blind, vehicle-controlled study. Arch. Intern. Med.151(11), 2225–2229 (1991).
   PubMedGoogle Scholar
• Agoons BB , DehayemYefou M , KatteJCet al. Effect of topical capsaicin on painful sensory peripheral neuropathy in patients with type 2 diabetes: a double-blind placebo-controlled randomised clinical trial. Cureus12(10), e11147 (2020).
   PubMed Web of Science ®Google Scholar
• Kulkantrakorn K , ChomjitA , SithinamsuwanP , TharavanijT , SuwankanoknarkJ , NapunnaphatP. 0.075% capsaicin lotion for the treatment of painful diabetic neuropathy: a randomized, double-blind, crossover, placebo-controlled trial. J. Clin. Neurosci.62, 174–179 (2019).
   PubMed Web of Science ®Google Scholar
• Thomas SE , LaycockH. The use of high dose topical capsaicin in the management of peripheral neuropathy: narrative review and local experience. Br. J. Pain14(2), 133–140 (2020).
   PubMed Web of Science ®Google Scholar
• Babbar S , MarierJF , MouksassiMSet al. Pharmacokinetic analysis of capsaicin after topical administration of a high-concentration capsaicin patch to patients with peripheral neuropathic pain. Ther. Drug Monit.31(4), 502–510 (2009).
   PubMed Web of Science ®Google Scholar
• Pabbidi MR , PremkumarLS. Role of transient receptor potential channels Trpv1 and Trpm8 in diabetic peripheral neuropathy. J. Diabetes Treat.2017(4), 29 (2017).
   Google Scholar
• Cortright DN , SzallasiA. Biochemical pharmacology of the vanilloid receptor TRPV1. An update. Eur. J. Biochem.271(10), 1814–1819 (2004).
   PubMedGoogle Scholar
• Chen X , DuanY , RileyAMet al. Long-term diabetic microenvironment augments the decay rate of capsaicin-induced currents in mouse dorsal root ganglion neurons. Molecules24(4), 775 (2019).
   PubMed Web of Science ®Google Scholar
• Martini C , YassenA , OlofsenE , PassierP , StokerM , DahanA. Pharmacodynamic analysis of the analgesic effect of capsaicin 8% patch (Qutenza™) in diabetic neuropathic pain patients: detection of distinct response groups. J. Pain Res.5, 51–59 (2012).
   PubMedGoogle Scholar
• Hayes AG , TyersMB. Effects of capsaicin on nociceptive heat, pressure and chemical thresholds and on substance P levels in the rat. Brain Res.189(2), 561–564 (1980).
   PubMed Web of Science ®Google Scholar
• Buck SH , MillerMS , BurksTF. Depletion of primary afferent substance P by capsaicin and dihydrocapsaicin without altered thermal sensitivity in rats. Brain Res.233(1), 216–220 (1982).
   PubMed Web of Science ®Google Scholar
• Szolcsanyi J , AntonF , ReehPW , HandwerkerHO. Selective excitation by capsaicin of mechano-heat sensitive nociceptors in rat skin. Brain Res.446(2), 262–268 (1988).
   PubMed Web of Science ®Google Scholar
• Baranowski R , LynnB , PiniA. The effects of locally applied capsaicin on conduction in cutaneous nerves in four mammalian species. Br. J. Pharmacol.89(2), 267–276 (1986).
   PubMed Web of Science ®Google Scholar
• McMahon SB , LewinG , BloomSR. The consequences of long-term topical capsaicin application in the rat. Pain44(3), 301–310 (1991).
   PubMed Web of Science ®Google Scholar
• Silva M , MartinsD , CharruaAet al. Endovanilloid control of pain modulation by the rostroventromedial medulla in an animal model of diabetic neuropathy. Neuropharmacology107, 49–57 (2016).
   PubMed Web of Science ®Google Scholar
• Shaqura M , KhalefaBI , ShakibaeiMet al. New insights into mechanisms of opioid inhibitory effects on capsaicin-induced TRPV1 activity during painful diabetic neuropathy. Neuropharmacology85, 142–150 (2014).
   PubMed Web of Science ®Google Scholar
• Rashid MH , InoueM , BakoshiS , UedaH. Increased expression of vanilloid receptor 1 on myelinated primary afferent neurons contributes to the antihyperalgesic effect of capsaicin cream in diabetic neuropathic pain in mice. J. Pharmacol. Exp. Ther.306(2), 709–717 (2003).
   PubMed Web of Science ®Google Scholar
• Mohammadi-Farani A , SahebgharaniM , SepehrizadehZ , JaberiE , Ghazi-KhansariM. Diabetic thermal hyperalgesia: role of TRPV1 and CB1 receptors of periaqueductal gray. Brain Res.1328, 49–56 (2010).
   PubMed Web of Science ®Google Scholar
• Hong S , WileyJW. Early painful diabetic neuropathy is associated with differential changes in the expression and function of vanilloid receptor 1. J. Biol. Chem.280(1), 618–627 (2005).
   PubMed Web of Science ®Google Scholar
• Facer P , CasulaMA , SmithGDet al. Differential expression of the capsaicin receptor TRPV1 and related novel receptors TRPV3, TRPV4 and TRPM8 in normal human tissues and changes in traumatic and diabetic neuropathy. BMC Neurol.7, 11 (2007).
   PubMed Web of Science ®Google Scholar
• Brederson JD , KymPR , SzallasiA. Targeting TRP channels for pain relief. Eur. J. Pharmacol.716(1–3), 61–76 (2013).
   PubMed Web of Science ®Google Scholar
• Rashid MH , InoueM , KondoS , KawashimaT , BakoshiS , UedaH. Novel expression of vanilloid receptor 1 on capsaicin-insensitive fibers accounts for the analgesic effect of capsaicin cream in neuropathic pain. J. Pharmacol. Exp. Ther.304(3), 940–948 (2003).
   PubMed Web of Science ®Google Scholar
• Blair HA . Capsaicin 8% dermal patch: a review in peripheral neuropathic pain. Drugs78(14), 1489–1500 (2018).
   PubMed Web of Science ®Google Scholar
• Malmberg AB , MizisinAP , CalcuttNA , von SteinT , RobbinsWR , BleyKR. Reduced heat sensitivity and epidermal nerve fiber immunostaining following single applications of a high-concentration capsaicin patch. Pain111(3), 360–367 (2004).
   PubMed Web of Science ®Google Scholar
• Kennedy WR , VanhoveGF , LuSPet 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. Pain11(6), 579–587 (2010).
   PubMed Web of Science ®Google Scholar
• [insert] Qp. 2009. Averitas Grunenthal, NJ, USA.
   Google Scholar
• Wohlrab J , NeubertRH , HeskampML , MichaelJ. Cutaneous drug delivery of capsaicin after in vitro administration of the 8% capsaicin dermal patch system. Skin Pharmacol. Physiol.28(2), 65–74 (2015).
   PubMed Web of Science ®Google Scholar
• Vinik AI , PerrotS , VinikEJet al. Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study. BMC Neurol.16(1), 251 (2016).
   PubMed Web of Science ®Google Scholar
• Simpson DM , Robinson-PappJ , VanJet al. Capsaicin 8% patch in painful diabetic peripheral neuropathy: a randomized, double-blind, placebo-controlled study. J. Pain18(1), 42–53 (2017).
   PubMed Web of Science ®Google Scholar
• Vinik A , PerrotS , VinikEet al. Repeat treatment with capsaicin 8% patch (179mg capsaicin cutaneous patch): effects on pain, quality of life, and patient satisfaction in painful diabetic peripheral neuropathy: an open-label, randomized controlled clinical trial. J. Curr. Med. Res. Opinion12(2), 388–401 (2019).
   Google Scholar
• Irving GA , BackonjaMM , DuntemanEet al. A multicenter, randomized, double-blind, controlled study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. Pain Med.12(1), 99–109 (2011).
   PubMed Web of Science ®Google Scholar
• Backonja M , WallaceMS , BlonskyERet al. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol.7(12), 1106–1112 (2008).
   PubMed Web of Science ®Google Scholar
• Derry S , RiceAS , ColeP , TanT , MooreRA. Topical capsaicin (high concentration) for chronic neuropathic pain in adults. Cochrane Database Syst. Rev.1, CD007393 (2017).
   PubMed Web of Science ®Google Scholar
• Üçeyler N , SommerC. High-dose capsaicin for the treatment of neuropathic pain: what we know and what we need to know. Pain Ther.3(2), 73–84 (2014).
   PubMedGoogle Scholar
• Gibbons CH , WangN , FreemanR. Capsaicin induces degeneration of cutaneous autonomic nerve fibers. Ann. Neurol.68(6), 888–898 (2010).
   PubMed Web of Science ®Google Scholar
• Polydefkis M , HauerP , ShethS , SirdofskyM , GriffinJW , McArthurJC. The time course of epidermal nerve fibre regeneration: studies in normal controls and in people with diabetes, with and without neuropathy. Brain127(Pt 7), 1606–1615 (2004).
   PubMedGoogle Scholar
• Webster LR , MalanTP , TuchmanMM , MollenMD , TobiasJK , VanhoveGF. A multicenter, randomized, double-blind, controlled dose finding study of NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia. J. Pain11(10), 972–982 (2010).
   PubMed Web of Science ®Google Scholar
• Webster LR , PeppinJF , MurphyFT , LuB , TobiasJK , VanhoveGF. 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.93(2), 187–197 (2011).
   PubMed Web of Science ®Google Scholar
• Backonja MM , MalanTP , VanhoveGF , TobiasJK , GroupCS. 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.11(4), 600–608 (2010).
   PubMed Web of Science ®Google Scholar
• Simpson DM , BrownS , TobiasJK , VanhoveGF. Group N-CS. 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. Pain30(2), 134–142 (2014).
   PubMed Web of Science ®Google Scholar
• Goncalves D , RebeloV , BarbosaP , GomesA. 8% capsaicin patch in treatment of peripheral neuropathic pain. Pain Physician23(5), E541–E548 (2020).
   PubMed Web of Science ®Google Scholar
• Lantéri-Minet M , PerrotS. QAPSA: post-marketing surveillance of capsaicin 8% patch for long-term use in patients with peripheral neuropathic pain in France. Curr. Med. Res. Opin.35(3), 417–426 (2019).
   PubMed Web of Science ®Google Scholar
• Mankowski C , PooleCD , ErnaultEet al. Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study. BMC Neurol.17(1), 80 (2017).
   PubMedGoogle Scholar
• Gálvez R , NavezML , MoyleGet al. Capsaicin 8% patch repeat treatment in nondiabetic peripheral neuropathic pain: a 52-week, open-label, single-arm, safety study. Clin. J. Pain33(10), 921–931 (2017).
   PubMed Web of Science ®Google Scholar
• Maihofner C , HeskampML. 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. Curr. Med. Res. Opin.29(6), 673–683 (2013).
   PubMed Web of Science ®Google Scholar
• Hansson P , JensenTS , KvarsteinG , StrömbergM. Pain-relieving effectiveness, quality of life and tolerability of repeated capsaicin 8% patch treatment of peripheral neuropathic pain in Scandinavian clinical practice. Eur. J. Pain22(5), 941–950 (2018).
   PubMed Web of Science ®Google Scholar
• Farrar JT , YoungJP , LaMoreauxL , WerthJL , PooleMR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain94(2), 149–158 (2001).
   PubMed Web of Science ®Google Scholar
• Peppin JF , MajorsK , WebsterLR , SimpsonDM , TobiasJK , VanhoveGF. Tolerability of NGX-4010, a capsaicin 8% patch for peripheral neuropathic pain. J. Pain Res.4, 385–392 (2011).
   PubMedGoogle Scholar
• Simpson DM , GazdaS , BrownSet al. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J. Pain Symptom Manage.39(6), 1053–1064 (2010).
   PubMed Web of Science ®Google Scholar
• Brown S , SimpsonDM , MoyleGet al. NGX-4010, a capsaicin 8% patch, for the treatment of painful HIV-associated distal sensory polyneuropathy: integrated analysis of two phase III, randomized, controlled trials. AIDS Res. Ther.10(1), 5 (2013).
   PubMedGoogle Scholar
• Burness CB , McCormackPL. Capsaicin 8 % patch: a review in peripheral neuropathic pain. Drugs76(1), 123–134 (2016).
   PubMed Web of Science ®Google Scholar
• Haanpää M , CruccuG , NurmikkoTJet al. Capsaicin 8% patch versus oral pregabalin in patients with peripheral neuropathic pain. Eur. J. Pain20(2), 316–328 (2016).
   PubMed Web of Science ®Google Scholar
• Yang XD , FangPF , XiangDX , YangYY. Topical treatments for diabetic neuropathic pain. Exp. Ther. Med.17(3), 1963–1976 (2019).
   PubMed Web of Science ®Google Scholar
• [No authors listed]. What role for capsaicin in diabetic peripheral neuropathy? Drug Ther. Bull. 54(8), 90–93 (2016).
   PubMedGoogle Scholar
• Handelsman Y , BloomgardenZT , GrunbergerGet al. American association of clinical endocrinologists and American college of endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan – 2015 – executive summary. Endocr. Pract.21(4), 413–437 (2015).
   PubMed Web of Science ®Google Scholar
• Ziegler D , FonsecaV. From guideline to patient: a review of recent recommendations for pharmacotherapy of painful diabetic neuropathy. J. Diabetes Complications29(1), 146–156 (2015).
   PubMed Web of Science ®Google Scholar
• Ardeleanu V , TomaA , PafiliKet al. Current pharmacological treatment of painful diabetic neuropathy: a narrative review. Medicina (Kaunas)56(1), 25 (2020).
   PubMed Web of Science ®Google Scholar
• Armstrong EP , MaloneDC , McCarbergB , PanaritesCJ , PhamSV. Cost–effectiveness analysis of a new 8% capsaicin patch compared to existing therapies for postherpetic neuralgia. Curr. Med. Res. Opin.27(5), 939–950 (2011).
   PubMed Web of Science ®Google Scholar
• Mankowski C , PatelS , TruemanD , BentleyA , PooleC. Cost–effectiveness of capsaicin 8% patch compared with pregabalin for the treatment of patients with peripheral neuropathic pain in Scotland. PLoS ONE11(3), e0150973 (2016).
   PubMed Web of Science ®Google Scholar
• Northern Treatment Advisory Group . pain. [Internet] Qutenza® capsaicin cutaneous patch for neuropathic pain. [Internet].( Ed.) (2016).
   Google Scholar
• Akçay AB , OzcanT , SeyisS , AceleA. Coronary vasospasm and acute myocardial infarction induced by a topical capsaicin patch. Turk. Kardiyol. Dern. Ars.37(7), 497–500 (2009).
   PubMedGoogle Scholar
• Bonezzi C , CostantiniA , CruccuGet al. Capsaicin 8% dermal patch in clinical practice: an expert opinion. Expert Opin. Pharmacother.21(11), 1377–1387 (2020).
   PubMed Web of Science ®Google Scholar