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Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study.
Curr Med Res Opin. 2009 May; 25(5):1295-305.CM

Abstract

OBJECTIVE

Evaluation of long-term efficacy and safety of the 5% lidocaine medicated plaster for neuropathic pain symptoms in patients with post-herpetic neuralgia (PHN).

MATERIALS AND METHODS

Design - a 12-month, open-label, phase III study with an open-label extension conducted at 34 outpatient clinics in 12 European countries. Patients - aged >or=50 years, newly recruited (average pain intensity >or=4) or pre-treated with the 5% lidocaine medicated plaster in a previous study. Interventions - application of up to three 5% lidocaine medicated plasters dependent upon size of the painful area for up to 12 hours per day. Outcome measures - efficacy measures included patients' recall of pain relief and pain intensity in the previous week. Adverse events (AEs) were also reported.

RESULTS

249 patients participated in the 12-month study, 247 were analysed (full analysis set, FAS). Newly recruited patients had a mean average pain intensity (11-point numerical rating scale [NRS]) of 5.9 +/- 1.4 at baseline, which decreased to 3.9 +/- 1.6 at week 12 and remained stable at 3.9 +/- 2.3 until the end of the 12-month study. In pre-treated patients, pain intensity decreased further from baseline (3.9 +/- 1.9) to study end (3.4 +/- 2.0). Pain relief values were consistent with pain intensity reductions and were sustained in patients continuing treatment in the extension phase (mainly >or=24 months treatment in total). The most common AEs tended to be infections such as bronchitis and nasopharyngitis. Forty-eight drug-related adverse events (DRAEs), mainly mild to moderate localised skin reactions, occurred in 31 (12.4%) patients in the first 12 months. The profile of DRAEs was similar in the extension phase.

CONCLUSIONS

This study suggests that long-term treatment with the 5% lidocaine medicated plaster may provide substantial and maintained reductions in pain intensity, and that it is continuously well tolerated in patients suffering from peripheral neuropathic pain associated with previous herpes zoster infection. These findings support the use of the 5% lidocaine medicated plaster as one of the first-line therapies in this population.

Authors+Show Affiliations

Multidisciplinary Pain Center (PCT), Antwerp University Hospital (UZA), Edegem, Belgium. guy.hans@uza.beNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19366301

Citation

Hans, Guy, et al. "Efficacy and Tolerability of a 5% Lidocaine Medicated Plaster for the Topical Treatment of Post-herpetic Neuralgia: Results of a Long-term Study." Current Medical Research and Opinion, vol. 25, no. 5, 2009, pp. 1295-305.
Hans G, Sabatowski R, Binder A, et al. Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study. Curr Med Res Opin. 2009;25(5):1295-305.
Hans, G., Sabatowski, R., Binder, A., Boesl, I., Rogers, P., & Baron, R. (2009). Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study. Current Medical Research and Opinion, 25(5), 1295-305. https://doi.org/10.1185/03007990902901368
Hans G, et al. Efficacy and Tolerability of a 5% Lidocaine Medicated Plaster for the Topical Treatment of Post-herpetic Neuralgia: Results of a Long-term Study. Curr Med Res Opin. 2009;25(5):1295-305. PubMed PMID: 19366301.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of a 5% lidocaine medicated plaster for the topical treatment of post-herpetic neuralgia: results of a long-term study. AU - Hans,Guy, AU - Sabatowski,Rainer, AU - Binder,Andreas, AU - Boesl,Irmgard, AU - Rogers,Peter, AU - Baron,Ralf, PY - 2009/4/16/entrez PY - 2009/4/16/pubmed PY - 2009/7/25/medline SP - 1295 EP - 305 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 25 IS - 5 N2 - OBJECTIVE: Evaluation of long-term efficacy and safety of the 5% lidocaine medicated plaster for neuropathic pain symptoms in patients with post-herpetic neuralgia (PHN). MATERIALS AND METHODS: Design - a 12-month, open-label, phase III study with an open-label extension conducted at 34 outpatient clinics in 12 European countries. Patients - aged >or=50 years, newly recruited (average pain intensity >or=4) or pre-treated with the 5% lidocaine medicated plaster in a previous study. Interventions - application of up to three 5% lidocaine medicated plasters dependent upon size of the painful area for up to 12 hours per day. Outcome measures - efficacy measures included patients' recall of pain relief and pain intensity in the previous week. Adverse events (AEs) were also reported. RESULTS: 249 patients participated in the 12-month study, 247 were analysed (full analysis set, FAS). Newly recruited patients had a mean average pain intensity (11-point numerical rating scale [NRS]) of 5.9 +/- 1.4 at baseline, which decreased to 3.9 +/- 1.6 at week 12 and remained stable at 3.9 +/- 2.3 until the end of the 12-month study. In pre-treated patients, pain intensity decreased further from baseline (3.9 +/- 1.9) to study end (3.4 +/- 2.0). Pain relief values were consistent with pain intensity reductions and were sustained in patients continuing treatment in the extension phase (mainly >or=24 months treatment in total). The most common AEs tended to be infections such as bronchitis and nasopharyngitis. Forty-eight drug-related adverse events (DRAEs), mainly mild to moderate localised skin reactions, occurred in 31 (12.4%) patients in the first 12 months. The profile of DRAEs was similar in the extension phase. CONCLUSIONS: This study suggests that long-term treatment with the 5% lidocaine medicated plaster may provide substantial and maintained reductions in pain intensity, and that it is continuously well tolerated in patients suffering from peripheral neuropathic pain associated with previous herpes zoster infection. These findings support the use of the 5% lidocaine medicated plaster as one of the first-line therapies in this population. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/19366301/Efficacy_and_tolerability_of_a_5_lidocaine_medicated_plaster_for_the_topical_treatment_of_post_herpetic_neuralgia:_results_of_a_long_term_study_ L2 - http://www.tandfonline.com/doi/full/10.1185/03007990902901368 DB - PRIME DP - Unbound Medicine ER -