1,288
Views
142
CrossRef citations to date
0
Altmetric
Original Article

5% lidocaine medicated plaster versus pregabalin in post-herpetic neuralgia and diabetic polyneuropathy: an open-label, non-inferiority two-stage RCT study

, , , , &
Pages 1663-1676 | Accepted 05 May 2009, Published online: 01 Jun 2009

References

  • Cruccu G, Anand P, Attal N, et al. EFNS guidelines on neuropathic pain assessment. Eur J Neurol 2004;11:153-62
  • Belgrade MJ. Following the clues to neuropathic pain. Distribution and other leads reveal the cause and the treatment approach. Postgrad Med 1999;106:127-32,135-40
  • Dworkin RH, O'Connor AB, Backonja M, et al. Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 2007;132:237-51
  • Gauthier A, Breuer J, Carrington D, et al. Epidemiology and cost of herpes zoster and post-herpetic neuralgia in the United Kingdom. Epidemiol Infect 2009;137:38-47
  • Daousi C, MacFarlane IA, Woodward A, et al. Chronic painful peripheral neuropathy in an urban community: a controlled comparison of people with and without diabetes. Diabet Med 2004;21:976-82
  • Veves A, Backonja M, Malik RA. Painful diabetic neuropathy: epidemiology, natural history, early diagnosis, and treatment options. Pain Med 2008;9:660-74
  • Liedgens H, Hertel N, Gabriel A, et al. Cost-effectiveness analysis of a lidocaine 5% medicated plaster compared with gabapentin and pregabalin for treating postherpetic neuralgia: a German perspective. Clin Drug Investig 2008;28:583-601
  • Annemans L, Caekelbergh K, Morlion B, et al. A cost–utility analysis of pregabalin in the management of peripheral neuropathic pain. Acta Clin Belg 2008;63:170-8
  • Electronic Medicines Compendium. Versatis® 5% Medicated Plaster Summary of Product Characteristics, 2008. Available at: http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=19291 [Last accessed 23 January 2009].
  • Gammaitoni AR, Alvarez NA, Galer BS. Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. J Clin Pharmacol 2003;43:111-17
  • Wu CL, Raja SN. An update on the treatment of postherpetic neuralgia. J Pain 2008;9:S19-30
  • Argoff CE. Topical treatments for pain. Curr Pain Headache Rep 2004;8:261-7
  • Davies PS, Galer BS. Review of lidocaine patch 5% studies in the treatment of postherpetic neuralgia. Drugs 2004;64:937-47
  • Gammaitoni AR, Davis MW. Pharmacokinetics and tolerability of lidocaine patch 5% with extended dosing. Ann Pharmacother 2002;36:236-40
  • Galer BS, Rowbotham MC, Perander J, et al. Topical lidocaine patch relieves postherpetic neuralgia more effectively than a vehicle topical patch: results of an enriched enrollment study. Pain 1999;80:533-8
  • Khaliq W, Alam S, Puri N. Topical lidocaine for the treatment of postherpetic neuralgia. Cochrane Database of Systematic Reviews 2007;Issue 2. Art No.:CD004846. DOI: 10.1002/14651858.CD004846.pub2
  • Rowbotham MC, Davies PS, Verkempinck C, et al. Lidocaine patch: double-blind controlled study of a new treatment method for post-herpetic neuralgia. Pain 1996;65:39-44
  • Baron R, Mayoral V, Leijon Get al. Efficacy and safety of 5% lidocaine (Lignocaine) medicated plaster in comparison with pregabalin in patients with postherpetic neuralgia and diabetic polyneuropathy interim analysis from an open-label, two-stage adaptive, randomized, controlled trial. Clin Drug Invest 2009;29(4):231-41
  • Argoff CE, Galer BS, Jensen MP, et al. Effectiveness of the lidocaine patch 5% on pain qualities in three chronic pain states: assessment with the Neuropathic Pain Scale. Curr Med Res Opin 2004;20(Suppl. 2):S21-8
  • Herrmann DN, Barbano RL, Hart-Gouleau S, et al. An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy. Pain Med 2005;6:379-84
  • Barbano RL, Herrmann DN, Hart-Gouleau S, et al. Effectiveness, tolerability, and impact on quality of life of the 5% lidocaine patch in diabetic polyneuropathy. Arch Neurol 2004;61:914-18
  • Dworkin RH, Corbin AE, Young JP Jr, et al. Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial. Neurology 2003;60:1274-83
  • Sabatowski R, Galvez R, Cherry DA, et al. Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial. Pain 2004;109:26-35
  • van Seventer R, Feister HA, Young JP Jr, et al. Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. Curr Med Res Opin 2006;22:375-84
  • Lesser H, Sharma U, LaMoreaux L, et al. Pregabalin relieves symptoms of painful diabetic neuropathy. Neurology 2004;63:2104-10
  • Richter RW, Portenoy R, Sharma U, et al. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain 2005;6:253-60
  • Rosenstock J, Tuchman M, LaMoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain 2004;110:628-38
  • Electronic Medicines Compendium. Lyrica capsules SPC, 2009. Available at: http://emc.medicines.org.uk/emc/assets/c/html/displayDocPrinterFriendly.asp?documentid=14651 [Last accessed 13 March 2009].
  • Finnerup NB, Otto M, Jensen TS, et al. An evidence-based algorithm for the treatment of neuropathic pain. MedGenMed 2007;9:36
  • Finnerup NB, Otto M, McQuay HJ, et al. Algorithm for neuropathic pain treatment: an evidence based proposal. Pain 2005;118:289-305
  • Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain 2005;113:9-19
  • Sindrup SH, Bach FW, Madsen C, et al. Venlafaxine versus imipramine in painful polyneuropathy: a randomized, controlled trial. Neurology 2003;60:1284-9
  • North Coast Medical Inc. Touch-Test™ Sensory Evaluator (5.46). Product code NC12775-16. 2008. Available at: http://www.ncmedical.com/item_1278.html [Last accessed 13 March 2009].
  • EuroQol – a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990;16:199-208
  • Vranken JH, Dijkgraaf MG, Kruis MR, et al. Pregabalin in patients with central neuropathic pain: a randomized, double-blind, placebo-controlled trial of a flexible-dose regimen. Pain 2008;136:150-7
  • Dodick DW, Silberstein S, Saper J, et al. The impact of topiramate on health-related quality of life indicators in chronic migraine. Headache 2007;47:1398-408
  • Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994;50:1029-41
  • Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med 1985;4:213-26
  • Galer BS, Jensen MP, Ma T, et al. The lidocaine patch 5% effectively treats all neuropathic pain qualities: results of a randomized, double-blind, vehicle-controlled, 3-week efficacy study with use of the neuropathic pain scale. Clin J Pain 2002;18:297-301
  • Meier T, Wasner G, Faust M, et al. Efficacy of lidocaine patch 5% in the treatment of focal peripheral neuropathic pain syndromes: a randomized, double-blind, placebo-controlled study. Pain 2003;106:151-8
  • Gilron I, Bailey JM, Tu D, et al. Morphine, gabapentin, or their combination for neuropathic pain. N Engl J Med 2005;352:1324-34
  • Khoromi S, Cui L, Nackers L, et al. Morphine, nortriptyline and their combination vs. placebo in patients with chronic lumbar root pain. Pain 2007;130:66-75
  • Quilici S, Chancellor J, Lothgren M, et al. Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurol 2009;9:6
  • Dworkin R, Farrar J, Griesing T, et al. (782) Predictors of patient global impression of change in peripheral neuropathic pain: Results from an analysis of 10 trials with pregabalin. J Pain 2006;7:S46
  • Dworkin RH, White R, O’Connor, et al. Health care costs of acute and chronic pain associated with a diagnosis of herpes zoster. Jam Geriatr Soc 2007;55:1168-75
  • Baron R, Binder A, Boesl Iet al. Long-term efficacy, safety and quality of life with lidocaine 5% medicated plaster in post-herpetic neuralgia. Pain in Europe V 5th Congress of the European Federation of IASP chapters (EFIC) Istanbul, Turkey, September 13–16, 2006; Abstract 787
  • Hans G, Baron R, Binder Aet al. Long-term efficacy and tolerability of a 5% lidocaine-medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study. IASP abstract 2008
  • Berndt S, Maier C, Schutz HW. Polymedication and medication compliance in patients with chronic non-malignant pain. Pain 1993;52:331-9
  • Giannopoulos S, Kosmidou M, Kyritsis AP. Patient compliance with neuropathic pain treatment. Pain 2008;136:447
  • Giannopoulos S, Kosmidou M, Sarmas I, et al. Patient compliance with SSRIs and gabapentin in painful diabetic neuropathy. Clin J Pain 2007;23:267-9
  • Glasser SP, Salas M, Delzell E. Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems. J Clin Pharmacol 2007;47:1074-86
  • Argoff CE. Lidocaine patch 5% and the management of chronic pain. South Med J 2002;95:781

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.