Efficacy and safety of 5% lidocaine-medicated plasters in localized pain with neuropathic and/or inflammatory characteristics: an observational, real-world study

摘要

OBJECTIVE: Based on clinical study results, 5% lidocaine-medicated plaster (5% LMP) is currently recommended for the treatment of localized peripheral neuropathic pain, such as post-herpetic neuralgia (PHN). However, its effective action, as well as the high safety, have indeed led to its use in clinical practice for pain conditions with similar pathophysiological mechanisms. In this study, the efficacy and safety of 5% LMP were investigated in patients with localized pain with neuropathic and/or inflammatory characteristics, such as PHN, post-traumatic/surgical or musculoskeletal pain. PATIENTS AND METHODS: 503 patients with localized pain treated with 5% LMP were evaluated at baseline (T0), after 30 days (T30) and after 60 days (T60). The primary endpoint was number and proportion of 30% responders at T60, whereas secondary endpoints included number and proportion of 30% responders at T30, mean pain intensity, mean extension of the painful area, dynamic mechanical allodynia and quality of sleep. Evaluations were assessed in all patients and subgroups based on different clinical entities. Concomitant treatments and adverse reactions were also recorded. RESULTS: 72% and 90% of all patients responded to 5% LMP treatment at T30 and T60, respectively. Comparable results were also obtained in subgroups such as PHN patients (72% and 68% at T30 and T60, respectively), and musculoskeletal pain (73% and 83% at T30 and T60, respectively). The mean pain intensity, as well as the extension of the painful area, significantly decreased during the study, in all patients and each subgroup. In addition, secondary endpoints significantly improved at each time-point compared with baseline, in all groups. CONCLUSIONS: The effectiveness and safety of 5% LMP were shown in localized pain conditions such as neuropathic and, importantly, in musculoskeletal pain, a condition never investigated with this product. This field-practice study suggests that topical pain-reducing strategies such as 5% LMP could be effective in neuropathic and/or inflammatory, localized pain conditions.