title: 5% lidocaine medicated plaster in elderly patients with postherpetic neuralgia: results of a compassionate use programme in France.
abstract: BACKGROUND
  Postherpetic neuralgia (PHN) is a common, debilitating complication of herpes zoster that has a major impact on patients' quality of life. PHN prevalence increases with advancing age. One treatment option is the topical analgesic 5% lidocaine (lignocaine) medicated plaster (Versatis®), which has been proven to be efficacious and well tolerated in a number of randomized clinical studies.
  
  
  OBJECTIVE
  The aim of this analysis was to assess the use of the lidocaine medicated plaster under clinical practice conditions in a patient population whose previous PHN treatment with antidepressant and/or antiepileptic agents was inadequate or was not tolerated, or for whom such treatment was contraindicated or not recommended.
  
  
  METHODS
  This was a prospective, multicentre, non-interventional observation conducted in private and public health centres in France under a compassionate use programme (CUP). To obtain this new - and, at the time, unauthorized - PHN treatment alternative, physicians (in accordance with French guidelines) had to complete standardized case report forms for each patient before his/her inclusion in the CUP. As it was a CUP and therefore a non-interventional observation, returning documented information on follow-up visits to the medication provider was voluntary, and only a limited number of physicians returned completed forms. Documentation was, however, mandatory for adverse events (AEs) occurrence. Depending on the size of the painful skin area, up to three lidocaine plasters daily were applied for a maximum of 12 hours with plaster-free intervals of at least 12 hours. The study assessed changes in the prescription of concomitant PHN medication from the start of lidocaine plaster treatment to the last follow-up visit, both in terms of the sum of all concomitant PHN treatments and stratified by type of treatment: antiepileptic drugs, tricyclic antidepressants (TCAs), serotonin reuptake inhibitors (SRIs), classical analgesics (classified as step 1, 2 or 3 according to the WHO cancer pain ladder), transcutaneous electrical nerve stimulation, and others (mainly NSAIDs). AEs were monitored for safety.
  
  
  RESULTS
  A total of 625 patients were included in the CUP and permitted to receive lidocaine plaster treatment. Physicians returned 273 documented follow-up visit report forms. The mean ± SD CUP duration (i.e. duration of lidocaine plaster treatment) was 2.4 ± 2.5 months (median 1 month). Efficacy was assessed in the group of patients with documented follow-up visits (n = 273; mean ± SD age 73.6 ± 11.2 years), of whom 184 were aged ≥70 years (elderly efficacy population). The safety analysis included 625 patients (mean ± SD age 73.2 ± 11.9 years). Lidocaine plaster treatment resulted in a significant mean reduction of one concomitant PHN treatment per patient in the overall efficacy population analysed at the end of the observation (p < 0.001). In both populations (overall efficacy and elderly efficacy population), significantly fewer patients received TCAs (p = 0.003 and p = 0.001, respectively), step 3 analgesics (p = 0.001 and p = 0.005, respectively), and other miscellaneous treatments (p < 0.001 for both populations); there was also a significant reduction in the proportion of patients who took step 2 analgesics (p = 0.009) in the overall efficacy group. AEs (mainly related to local plaster application) were documented for 2.6% of the patients in the safety population; none were considered serious.
  
  
  CONCLUSIONS
  In day-to-day clinical practice management of PHN, treatment with the 5% lidocaine medicated plaster permitted a significant quantitative reduction in concomitant treatments for neuropathic pain in the overall efficacy population. In the subgroup aged ≥70 years, the quantitative reduction was non-significant. However, in both populations, 5% lidocaine medicated plaster reduced use of TCAs and step 3 analgesics. An improved polymedication status and good tolerability in this likely multimorbid age group indicate that the plaster is a new therapeutic alternative for patients suffering from PHN in France.
authors.affiliation: Centre Hospitalier, Consultation Pluridisciplinaire de la Douleur, Chateauroux, France.
authors.forename: Florentin
authors.initials: F
authors.lastname: Clère
authors.forename: Claire
authors.initials: C
authors.lastname: Delorme-Morin
authors.forename: Brigitte
authors.initials: B
authors.lastname: George
authors.forename: Malou
authors.initials: M
authors.lastname: Navez
authors.forename: Bruno
authors.initials: B
authors.lastname: Rioult
authors.forename: Florence
authors.initials: F
authors.lastname: Tiberghien-Chatelain
authors.forename: Hervé
authors.initials: H
authors.lastname: Ganry
mesh_terms: D000368:Aged; D000927:Anticonvulsants / Q000627:therapeutic use; D000928:Antidepressive Agents / Q000627:therapeutic use; D002133:Calcium Sulfate / Q000008:administration & dosage*; D057176:Compassionate Use Trials / Q000379:methods*; D005260:Female; D005602:France; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage* / Q000627:therapeutic use*; D008297:Male; D051474:Neuralgia, Postherpetic / Q000188:drug therapy*; D017211:Treatment Failure
chemical_list: D000927:Anticonvulsants; D000928:Antidepressive Agents; D008012:Lidocaine; D002133:Calcium Sulfate