Treatment of postherpetic neuralgia with 5% lidocaine medicated plaster in elderly patients – subgroup analyses from three European clinical trials

Abstract

Objective: To investigate short- and long-term effectiveness and safety of the 5% lidocaine medicated plaster in the treatment of postherpetic neuralgia (PHN) in elderly patients (≥70 years of age).

Methods: Data from three European clinical trials was compared after stratification according to age (<70 years and ≥70 years). Length of study phase investigated was 4 weeks for study 1, 8 weeks for study 2, and up to 12 months for study 3. Effectiveness outcome measures were pain intensity, pain relief, allodynia severity, Clinical Global Impression of Change, and Patient Global Impression of Change. Safety was assessed by adverse event documentation.

Results: Mean average pain intensity improved in the elderly by −2.1 (SD 2.1) vs. −2.5 (SD 2.0) for <70 year old patients after 4 weeks, by −1.4 (SD 1.8) vs. −1.7 (SD 1.3) after 8 weeks, and by −1.5 (SD 1.9) vs. −2.7 (SD 2.2) after 12 months. Most patients presented with allodynia (>85% of elderly, >78% of younger patients) which was described by >51% as painful or extremely painful. Allodynia severity was markedly reduced in both groups during all three trials. Drug-related adverse events occurred in <20% of elderly and <15% of <70 year old patients and were mainly skin related.

Conclusions: The 5% lidocaine medicated plaster provided pain relief and marked reductions in allodynia severity in elderly PHN patients with an excellent safety profile under short- and long-term treatment supporting the addition of the plaster to the treatment armamentarium for this age group.

Study limitations: All analyzed study phases were open-label and lacking a placebo control group.

Keywords:

• Effectiveness
• elderly
• 5% lidocaine medicated plaster
• pain
• postherpetic neuralgia
• safety
• topical treatment

Note

Transparency

Declaration of funding

This analysis was funded and performed by Grünenthal GmbH, Germany.

Author contributions: I.B., S.K. and B.B. were involved in conception and design of this analysis and in data analysis. All authors were involved in data interpretation, manuscript writing, and critical revision of the manuscript for intellectual content. All authors approved the final version to be published and agree to be accountable for all aspects of the work.

Declaration of financial/other relationships

R.S. and T.M. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. I.B., S.K. and B.B. have disclosed that they are employees of Grünenthal GmbH, Germany. R.B. has received grants/research support from Pfizer, Genzyme GmbH, Grünenthal GmbH, and Mundipharma; he is a member of the EU Project No 633491: DOLORisk; he is a member of the IMI “Europain” collaboration and industry members of this are: Astra Zeneca, Pfizer, Esteve, UCB-Pharma, Sanofi Aventis, Grünenthal GmbH, Eli Lilly and Boehringer Ingelheim Pharma GmbH & Co. KG; German Federal Ministry of Education and Research (BMBF): member of the ERA_NET NEU-RON/IM-PAIN Project, German Research Network on Neuropathic Pain, NoPain system biology and German Research Foundation (DFG); he has received speaking fees from Pfizer, Genzyme GmbH, Grünenthal GmbH, Mundipharma, Sanofi Pasteur, Medtronic Inc. Neuromodulation, Eisai Co. Ltd., Lilly GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Astellas, Desitin, Teva Pharma, Bayer Schering, MSD GmbH and Seqirus; he has been a consultant for Pfizer, Genzyme GmbH, Grünenthal GmbH, Mundipharma, Allergan, Sanofi Pasteur, Medtronic Inc. Neuromodulation, Eisai Co. Ltd., Lilly GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Astellas, Novartis, Bristol-Myers-Squibb, Biogenidec, AstraZeneca, Merck, Abbvie, Daiichi Sankyo, Glenmark Pharmaceuticals, Seqirus, Teva Pharma, Genentech and Galapagos NV.

CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no relevant financial or other relationships to disclose.

Acknowledgments

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

Notes

1 Versatis is a registered trade name of Grünenthal GmbH, Aachen, Germany