Analgesic efficacy of the 5% lidocaine patch (Versatis®) versus non-steroidal anti-inflammatory drugs (NSAIDs) in off-label indications ; Efficacité antalgique de l’emplâtre lidocaïne 5 % (Versatis®) versus celle des anti-inflammatoires non stéroïdiens (AINS) dans les indications hors Autorisation de mise sur le marché (AMM)

The 5% lidocaine patch (Versatis®) is recognized as a treatment for postherpetic neuropathic pain. However, its off-label use is common. Several authors suggest its efficacy on the neuropathic component of various pain disorders, including those traditionally considered nociceptive. For these conditions, nonsteroidal anti-inflammatory drugs (NSAIDs) are often the first-line treatment, despite modest effectiveness and associated risk of adverse effects. In 2023, we conducted an observational, retrospective, multicenter non-inferiority study in France, with data collection via questionnaires. The primary objective was to assess the non-inferiority of the 5% lidocaine patch in pain relief compared to oral NSAIDs, measured on a scale from 0 to 100%. Secondary objectives included describing the patient population characteristics and comparing changes in activity limitations and adverse effects of both treatments. We included 63 patients who used the patch off-label, with the majority using it for back pain (36.5%) and applying it to the lumbar region (39.7%). In a subsample of 46 patients who used both the 5% lidocaine patch and oral NSAIDs for the same indication, the patch proved non-inferior to NSAIDs (95% CI, p < 0.005) and had significantly fewer adverse effects (p = 0.004). Subgroup analysis revealed that the patch was also non-inferior to ibuprofen, both in the entire group that used ibuprofen (p = 0.002) and specifically for patients using ibuprofen for back pain (p = 0.003). Concerning the changes in activity limitations, there was no statistically significant difference between the patch and NSAIDs (p = 0.133). We suggest that the 5% lidocaine patch could provide comparable relief to oral NSAIDs in the pain management of syndromes for which it is prescribed off-label, especially for patients at high risk of adverse effects. Additional randomized prospective trials are needed to strengthen our conclusions. ; L‘utilisation hors autorisation de mise sur le marché (AMM) de l’emplâtre de lidocaïne 5 % ...