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An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy.
Pain Med. 2005 Sep-Oct; 6(5):379-84.PM

Abstract

OBJECTIVE

Painful idiopathic distal sensory polyneuropathy is common, but has been largely ignored as a model for the evaluation of neuropathic pain therapies. We have therefore conducted a safety, tolerability, and effectiveness study of the lidocaine patch 5% in painful idiopathic distal sensory polyneuropathy.

DESIGN

A prospective open-label, flexible dosing, 3-week study period with a 5-week extension.

SETTING

Peripheral Neuropathy clinics and Anesthesiology Clinical Research Center at a tertiary care facility.

PATIENTS

Twenty subjects with a diagnosis of idiopathic distal sensory polyneuropathy (with or without associated impaired glucose tolerance), with a baseline mean pain daily rating of > or =4 on a visual analog scale. Intervention. Lidocaine patch 5%, maximum of four patches daily for 18 hours.

MAIN OUTCOME MEASURE

Change from baseline week to week 3 mean daily diary pain ratings. Secondary endpoints included assessments of safety and tolerability as well as quality of life measures.

RESULTS

Subjects with idiopathic distal sensory polyneuropathy, both with and without impaired glucose tolerance, showed significant improvements in pain and quality of life outcome measures over a 3-week treatment period. These improvements were maintained in a subgroup of patients treated for an additional 5 weeks and permitted a taper of concomitant analgesics in 25% of subjects. The lidocaine patch 5% was well tolerated.

CONCLUSIONS

The lidocaine patch 5% appeared well tolerated and potentially effective in the management of painful idiopathic distal sensory polyneuropathy. Idiopathic distal sensory polyneuropathy is an appropriate patient population for the conduct of clinical trials of neuropathic pain therapies.

Authors+Show Affiliations

Department of Neurology, University of Rochester, Rochester, New York 14642, USA. David_Herrmann@urmc.rochester.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16266359

Citation

Herrmann, David N., et al. "An Open-label Study of the Lidocaine Patch 5% in Painful Idiopathic Sensory Polyneuropathy." Pain Medicine (Malden, Mass.), vol. 6, no. 5, 2005, pp. 379-84.
Herrmann DN, Barbano RL, Hart-Gouleau S, et al. An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy. Pain Med. 2005;6(5):379-84.
Herrmann, D. N., Barbano, R. L., Hart-Gouleau, S., Pennella-Vaughan, J., & Dworkin, R. H. (2005). An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy. Pain Medicine (Malden, Mass.), 6(5), 379-84.
Herrmann DN, et al. An Open-label Study of the Lidocaine Patch 5% in Painful Idiopathic Sensory Polyneuropathy. Pain Med. 2005 Sep-Oct;6(5):379-84. PubMed PMID: 16266359.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An open-label study of the lidocaine patch 5% in painful idiopathic sensory polyneuropathy. AU - Herrmann,David N, AU - Barbano,Richard L, AU - Hart-Gouleau,Stephanie, AU - Pennella-Vaughan,Janet, AU - Dworkin,Robert H, PY - 2005/11/4/pubmed PY - 2006/6/9/medline PY - 2005/11/4/entrez SP - 379 EP - 84 JF - Pain medicine (Malden, Mass.) JO - Pain Med VL - 6 IS - 5 N2 - OBJECTIVE: Painful idiopathic distal sensory polyneuropathy is common, but has been largely ignored as a model for the evaluation of neuropathic pain therapies. We have therefore conducted a safety, tolerability, and effectiveness study of the lidocaine patch 5% in painful idiopathic distal sensory polyneuropathy. DESIGN: A prospective open-label, flexible dosing, 3-week study period with a 5-week extension. SETTING: Peripheral Neuropathy clinics and Anesthesiology Clinical Research Center at a tertiary care facility. PATIENTS: Twenty subjects with a diagnosis of idiopathic distal sensory polyneuropathy (with or without associated impaired glucose tolerance), with a baseline mean pain daily rating of > or =4 on a visual analog scale. Intervention. Lidocaine patch 5%, maximum of four patches daily for 18 hours. MAIN OUTCOME MEASURE: Change from baseline week to week 3 mean daily diary pain ratings. Secondary endpoints included assessments of safety and tolerability as well as quality of life measures. RESULTS: Subjects with idiopathic distal sensory polyneuropathy, both with and without impaired glucose tolerance, showed significant improvements in pain and quality of life outcome measures over a 3-week treatment period. These improvements were maintained in a subgroup of patients treated for an additional 5 weeks and permitted a taper of concomitant analgesics in 25% of subjects. The lidocaine patch 5% was well tolerated. CONCLUSIONS: The lidocaine patch 5% appeared well tolerated and potentially effective in the management of painful idiopathic distal sensory polyneuropathy. Idiopathic distal sensory polyneuropathy is an appropriate patient population for the conduct of clinical trials of neuropathic pain therapies. SN - 1526-2375 UR - https://www.unboundmedicine.com/medline/citation/16266359/An_open_label_study_of_the_lidocaine_patch_5_in_painful_idiopathic_sensory_polyneuropathy_ L2 - https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2005.00058.x DB - PRIME DP - Unbound Medicine ER -