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Topical 5% Lidocaine (Lignocaine) Medicated Plaster Treatment for Post-Herpetic Neuralgia

Results of a Double-Blind, Placebo-Controlled, Multinational Efficacy and Safety Trial

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Abstract

Background and objective: Post-herpetic neuralgia (PHN) is a distressing neuropathic pain condition mainly affecting elderly patients. Neuropathic pain symptoms can be of a burning, shooting and stabbing nature, and may continue for prolonged periods and are often poorly controlled by polymedication. The aim of this study was to evaluate the analgesic efficacy and safety of topical analgesic treatment (5% lidocaine [lignocaine] medicated plaster) compared with placebo plaster in patients with PHN.

Methods: This was a double-blind, placebo plaster-controlled, parallel-group, multicentre study employing enriched enrolment with randomized withdrawal methodology. After an initial 8-week open-label, active run-in phase, responders entered a 2-week randomized, double-blind, placebo-controlled phase. The study was conducted at 33 outpatient investigational centres in 12 European countries. Patients with PHN were selected who were aged ≥50 years, had experienced neuropathic pain persisting for ≥3 months after rash healing, and had a mean pain intensity of ≥4 on an 11-point numerical rating scale. A total of 265 patients entered the open-label phase and subsequently a pre-defined number of 71 patients entered the randomized phase. Patients applied up to three 5% lidocaine medicated plasters for up to 12 hours per day. The primary endpoint of the study was time-to-exit due to a ≥2-point reduction in pain relief on two consecutive days of plaster application using a 6-point verbal rating scale.

Results: Of the 265 patients entering the run-in phase, 51.7% achieved at least moderate pain relief. In the double-blind phase (full analysis set, n = 71), median times-to-exit were 13.5 (range 2–14) and 9.0 (range 1–14) days for lidocaine and placebo plaster groups, respectively (p = 0.151). For per-protocol patients (n = 34), median time-to-exit was 14.0 (range 3–14) and 6.0 (range 1–14) days for lidocaine and placebo plaster groups, respectively (p = 0.0398). Drug-related adverse events occurred in 13.6% of patients. Treatment with 5% lidocaine medicated plaster was associated with improvements in pain, allodynia, quality of life and sleep measures.

Conclusions: This study adds to a growing body of evidence that the 5% lidocaine medicated plaster can be considered a valuable treatment option for patients with PHN, providing beneficial effects on pain, allodynia, quality of life and sleep, with minimal adverse effects.

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Acknowledgements

This study was funded by Grünenthal GmbH. The authors would like to thank the clinical investigators who took part in this study. Medical writing assistance was provided by Wolters Kluwer Health Medical Communications; this assistance was funded by Grünenthal GmbH.

A. Binder has received honoraria from Allergan, Schwarz, Pfizer and Grünenthal. J. Bruxelle is a consultant for Pfizer, Janssen-Cilag, Eli Lilly, Mundipharma, Grünenthal and Sanofi-Pasteur MSD. P. Rogers has received honoraria and research funding from Grünenthal. G. Hans has received research funding from Grünenthal and Pierre-Fabre. I. Bösl is an employee of Grünenthal. R. Baron has received honoraria from Allergan, Schwarz, Pfizer, Grünenthal, Sanofi-Pasteur and Genzyme and received research funding from Pfizer, Grünenthal and Genzyme.

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Authors and Affiliations

  1. Division of Neurological Pain Research and Therapy, Department of Neurology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Haus 41, Arnold-Heller-Str. 3, Kiel, 24105, Germany

    Andreas Binder & Ralf Baron

  2. Multidisciplinary Pain Center, Cochin Hospital - AP-HP, Paris, France

    Jean Bruxelle

  3. Department of Pain Medicine, St Mary’s Hospital, Portsmouth, UK

    Peter Rogers

  4. Multidisciplinary Pain Center (PCT), Antwerp University Hospital (UZA), Edegem, Belgium

    Guy Hans

  5. Grünenthal GmbH Development Science Analgesics, Aachen, Germany

    Irmgard Bösl

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  1. Andreas Binder
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  2. Jean Bruxelle
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Correspondence to Andreas Binder.

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Binder, A., Bruxelle, J., Rogers, P. et al. Topical 5% Lidocaine (Lignocaine) Medicated Plaster Treatment for Post-Herpetic Neuralgia. Clin. Drug Investig. 29, 393–408 (2009). https://doi.org/10.2165/00044011-200929060-00003

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