Lidocaine 700 mg Medicated Plaster for Postherpetic Neuralgia: Real-World Data from the German Pain E-Registry

Abstract

Aim: To provide real-world evidence for the effectiveness and tolerability of lidocaine 700 mg medicated plaster (LMP) compared with oral systemic first-line medications (OSM) in postherpetic neuralgia treatment. Patients & methods: Retrospective cohort study in patients refractory to at least one recommended OSM (single drug or a combination of drugs) using anonymized routine medical care data from the German Pain e-Registry. A matched pair approach using propensity score matching was employed. Results: A total of 1711 data sets of postherpetic neuralgia patients were identified per treatment group. The majority (>60%) had experienced pain for more than a year and reported a high burden of pain and reduced quality of life. Six months of LMP treatment provided significantly greater pain reductions, improvements in pain-related impairments and quality of life than OSM treatment (p < 0.001 for all parameters). Drug-related adverse events and treatment discontinuation due to drug-related adverse events also occurred less frequently under LMP treatment (p < 0.001). Conclusion: These real-world data confirm the effectiveness and good tolerability of LMP under routine medical care. The treatment was significantly more effective when compared with first-line oral systemic medications.

Lay abstract

Postherpetic neuralgia is the most common complication of shingles. It is a chronic condition causing burning pain that persists long after the shingles rash disappears. There are several oral and topical medications available for pain treatment. Our study compared the effectiveness and tolerability of the topical lidocaine 700 mg medicated plaster with oral medications using anonymized patient data from German clinical practices collected in a pain registry (1711 patient data sets per treatment). Six months of treatment with the lidocaine plaster resulted in better pain relief, fewer restrictions in daily life activities, and better quality of life for the patients than the oral medications investigated. The lidocaine plaster was also significantly better tolerated. The lidocaine 700 mg medicated plaster is effective and well tolerated in routine medical practice.

Keywords::

• lidocaine 700 mg medicated plaster
• neuropathic pain
• oral systemic medication
• postherpetic neuralgia
• real-word data
• registry data
• routine medical care
• topical treatment

Author contributions

MA Überall, I Bösl, I Sabatschus, E Hollanders and M Eerdekens contributed in conception and design. MA Überall contributed in data extraction and data analysis. MA Überall, I Bösl, I Sabatschus, E Hollanders, M Eerdekens contributed in data interpretation. All authors critically revised for important intellectual content, approved the final manuscript version and agreed to the submission.

Acknowledgments

The authors thank GHH Müller-Schwefe for his critical assessment and interpretation of the data.

Financial & competing interests disclosures

MA Überall is a physician, pain specialist, medical director of the Institute of Neurological Sciences, and CEO of O Meany-MDPM GmbH, which was responsible for data extraction and biometrical analyses. Data extraction and biometrical analyses have been paid for by Grünenthal GmbH, Germany. MA Überall received financial support and/or expenses in form of research money, consultancy fees and/or remunerations for lecture activities from: Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Glaxo Smith Kline, Grünenthal, Hapa Medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionoghi, Spectrum Therapeutics, Teva, and Tilray. M Eerdekens, I Bösl, E Hollanders, and I Sabatschus are employees of Grünenthal GmbH, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing and editorial assistance was provided by E Grosselindemann and B Brett and was paid for by Grünenthal GmbH, Germany.

Ethical conduct of research

The study is registered in the European Union electronic Registry of Post-Authorization Studies (EUPAS 32826) through the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance^® coordinated by the European Medicines Agency and was conducted in accordance with the Declaration of Helsinki and relevant national and regulatory requirements; approval was granted by the independent ethics committee of the German Pain Association. All patients provided written informed consent prior to participation in the registry. All analyses were carried out using only anonymized data to comply with German guidelines on protection of data privacy and with the European Union General Data Protection Regulation.

Additional information

Funding

MA Überall is a physician, pain specialist, medical director of the Institute of Neurological Sciences, and CEO of O Meany-MDPM GmbH, which was responsible for data extraction and biometrical analyses. Data extraction and biometrical analyses have been paid for by Grünenthal GmbH, Germany. MA Überall received financial support and/or expenses in form of research money, consultancy fees and/or remunerations for lecture activities from: Allergan, Almirall, Amicus Therapeutics, Aristo Pharma, Bionorica, Glaxo Smith Kline, Grünenthal, Hapa Medical, Hexal, IMC, Kyowa-Kirin, Labatec, Mucos, Mundipharma, Nestle, Pfizer, Recordati, Servier, SGP-Pharma, Shionoghi, Spectrum Therapeutics, Teva, and Tilray. M Eerdekens, I Bösl, E Hollanders, and I Sabatschus are employees of Grünenthal GmbH, Germany. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing and editorial assistance was provided by E Grosselindemann and B Brett and was paid for by Grünenthal GmbH, Germany.