Efficacy and tolerability of a 5% lidocaine medicated plaster in adult patients with localized neuropathic pain: a retrospective analysis of open-label real-world data provided by the German Pain e-Registry (EVERS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  Evaluation of efficacy/tolerability in comparable patient populations of the German Pain e-Registry (GPeR) with insufficient pain relief following at least one first line oral therapy for P-LNP other than post herpetic neuralgia (PHN) (single drug or with addition of another drug) who either switched to topical 5% topical lidocaine medicated plaster or to other recommended oral 1st line drugs.
• Outcomes:
  Primary endpoint: Absolute change of the average 24h pain intensity (so called pain index, PIX, mm VAS) to baseline after a treatment duration of 4 weeks, 3 months, and 6 months vs baseline, measured using a 100 mm visual analogue scale (VAS), Differential efficacy in different subgroups of P-LNP (postherpetic neuralgia, diabetic polyneuropathiy, postsurgial neuropathic pain, and others), drug-related adverse events (systemic and local) and associated treatment discontinuations.
• Data analysis plan:
  The absolute change of the average 24h pain intensity (so called pain index, PIX, mm VAS) to baseline after a treatment duration of 4 weeks, 3 months, and 6 months vs baseline, measured using a 100 mm visual analogue scale (VAS). A mixed-model repeated measures (MMRM) analysis adjusted for potential confounding factors such as age, gender, average 24-hour baseline pain intensity, pain severity (von Korff scale), stage of chronification, history/duration of pain (<3/≥3 months), comorbidity, subtype of P-LNP indication and prior medication) will be the primary analytical technique to assess mean change in the primary efficacy measures. The secondary efficacy objectives will be addressed by conducting MMRM and/or ANCOVA analyses. Safety will be assessed by summarizing and analyzing the frequency and spectrum of drug-related adverse events (DRAEs), and treatment discontinuations (rates and reasons).