Patient perceptions associated with the 5% lidocaine medicated plaster in daily practice

Abstract

Objective:

To evaluate patients’ perceptions of 5% lidocaine medicated plaster for treatment of chronic neuropathic pain in daily clinical practice.

Research design and methods:

In a prospective, multicentre, non-interventional observation, patient-reported outcome data were collected in clinical practices in Germany using the German Pain Questionnaire for pre-treatment documentation and the German Pain Diary for documentation of weekly treatment-associated changes. Questionnaires were completed by the patients without input from their physicians.

Main outcome measures:

Mean changes over the 12-week treatment period in pain intensity, in impairments of daily activities (modified pain disability index, mPDI) and of quality of life (quality of life impairment by pain inventory, QLIP), in Hospital Anxiety and Depression Scale scores (HADS-A and HADS-D), and in overall burden of pain.

Results:

Data of 922 patients were evaluated. Mean average pain intensity over 24 h improved by 5.1 points (74%) from 6.9 ± 1.6 points at baseline. A 30% reduction in overall pain intensity was already observed within the first 2–3 weeks with continuous further reductions until end of observation. Marked improvements in anxiety and depression scores (40% and 52%, respectively), and in pain-related restrictions in daily life activities (66%) and quality of life (157%) were also noted. Burden of pain was reduced by 56.2 points (73%) from 77.5 points at baseline. Stratification by diagnosis showed a treatment effect of lidocaine plaster for all underlying conditions with highest treatment effects for diabetic polyneuropathy and postherpetic neuralgia.

Conclusions:

In a patient population where 46% of individuals already suffered from chronic to markedly chronic pain, patients perceive the 5% lidocaine medicated plaster as an efficacious topical treatment of chronic neuropathic pain in daily clinical practice. Strongest pain relief as well as associated improvements in pain-related restrictions were observed within the first five treatment weeks; however, beneficial effects continued until end of observation.

Keywords::

• 5% lidocaine medicated plaster
• Neuropathic pain
• Non-interventional observation
• Pain relief
• Patient perceptions
• Routine clinical practice
• Topical analgesic

Transparency

Declaration of funding

Grünenthal GmbH, Aachen, Germany acquired the analysed data and provided funding for all costs associated with the development and publication of the present manuscript. Grünenthal was given the opportunity to review the present manuscript and suggest changes; however, responsibility for both the content of the manuscript and the presented data lies with the authors.

The study was initiated by the German Pain Association (Deutsche Gesellschaft für Schmerztherapie) and the German Pain League (Deutsche Schmerzliga) and carried out by the Interdisciplinary Centre for Pain Therapy and Palliative Care, Göppingen, Germany and the Institute for Neurological Sciences, Algesiology and Paediatrics, Nürnberg, Germany.

Declaration of financial/other relationships

No honoraria were paid to the authors for the preparation of this article. M.A.Ü. has disclosed that he has received in the past 12 months compensation for consulting or speaking fees from Astellas, Bene-Arzneimittel, Eisai, Grünenthal, Janssen-Cilag, Mundipharma, Nycomed, Pfizer, PharmAllergan, ProStrakan and TEVA. G.H.H.M.-S. has disclosed that he has received compensation for consulting or speaking fees from Cephalon, Eisai, Grünenthal, Janssen-Cilag, Mundipharma, Pfizer, PharmAllergan and TEVA.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgement

The authors wish to thank all participating patients for their contributions. Further thanks go to Elke Grosselindemann (Brett Medical Writing, Australia) and Birgit Brett (Brett Medical Writing, Germany) for writing and editorial assistance and publication coordination. All costs associated with the publication of the manuscript were met by Grünenthal.

Part of the manuscript data were presented as a poster at the 6th Congress of the European Federation of IASP Chapters (EFIC), Lisbon, Portugal, 9–12 September 2009.

Notes

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